Manualized social skills group training for children and adolescents with higher functioning autism spectrum disorder: protocol of a naturalistic multicenter, randomized controlled trial

STUDY PROTOCOL

Manualized social skills group training for children and adolescents with higher functioning autism spectrum disorder: protocol of a naturalistic multicenter, randomized controlled trial

Nora Choque Olsson1,2, Kristiina Tammimies1,2 and Sven Bölte1,2*

1Center of Neurodevelopmental Disorders (KIND), Pediatric Neuropsychiatry Unit, Department of Women’s and Children’s Health, Karolinska Institutet, Stockholm, Sweden, and 2Center for Psychiatry Research, Stockholm County Council, Stockholm, Sweden

Abstract

Autism spectrum disorder (ASD) is a lifelong neurodevelopmental disorder characterized by impairments in social communication and interaction, and the presence of stereotyped, repetitive and restricted behavior, interests, and activities. Despite prior studies showing moderate efficacy of social skills group training (SSGT) for children and adolescents with ASD, its effectiveness remains unclear. To investigate the efficacy and effectiveness of SSGT, we have initiated a large randomized controlled multicenter trial of the manualized SSGT program ‘KONTAKT’ in N=288 children and adolescents with high functioning ASD and psychiatric comorbidities (attention deficit hyperactivity disorder, anxiety, and depression) recruited from 14 clinical units. Based on stratification for age group (children vs. adolescents) and lengths of intervention (short vs. long), the participants are randomly assigned to SSGT KONTAKT training (n=144) or to treatment as usual (n=144). Outcomes are assessed by blinded teachers and unblinded parents on the Social Responsiveness Scale (primary outcomes), participant’s self-reports, and clinician ratings using well-established instruments for adaptive skills, general psychopathology, and experienced stress (secondary outcomes). We expect that participants receiving SSGT KONTAKT will show improved social responsiveness and everyday functioning, decreased general symptom severity, and perceived stress compared to standard care. Moreover, we predict that participant characteristics such as genetic predisposition, age, IQ, sex, verbal skills, and comorbidity moderate treatment effects.

Keywords: autism spectrum disorder; Asperger syndrome; treatment; social skills training; group training; comorbidity; intervention; evidence-based

Citation: Translational Developmental Psychiatry 2015, 3: 29825 - http://dx.doi.org/10.3402/tdp.v3.29825

Copyright: © 2015 Nora Choque Olsson et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License, permitting all non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Received: 20 September 2015; Revised: 4 November 2015; Accepted: 8 November 2015; Published: 14 December 2015

Competing interests and funding: Sven Bölte receives royalties for the German and Swedish KONTAKT manuals from Hogrefe Publishers. The other authors declare that there is no conflict of interests regarding the publication of this paper. The current study is supported by the Stockholm County Council, the Swedish Research Council in cooperation with all Swedish County Councils, Stiftelsen Barnforskningen, Stiftelsen Sunnerdahls Handikappfond, Majblomman, and Sällskapet Barnavård. Sven Bölte is supported by the Swedish Research Council (grant no. 523-2009-7054). Kristiina Tammimies is supported by Swedish Foundation of Strategic Research (grant no. ICA14-0028).

*Correspondence to: Sven Bölte, Center of Neurodevelopmental Disorders (KIND), Pediatric Neuropsychiatry Unit, Department of Women’s and Children’s Health, Karolinska Institutet, Gävlegatan 22B, SE-113 30 Stockholm, Sweden, Email: sven.bolte@ki.se

 

Autism spectrum disorder (ASD) is characterized by impairments in social communication and interaction alongside repetitive, stereotyped behavior and restricted interests. ASD is currently considered incurable (1), although treatable to varying degrees to prevent worse outcomes (2). The prevalence of ASD is at present estimated from 1% (3, 4) to almost 3% (5) of the population indicating a sharp rise during recent decades (6, 7). Social communication and interaction difficulties of ASD include a lack or uninformative use of verbal or non-verbal communication signals in social situations, poor peer relationships, social awareness, orientation, and social–emotional reciprocity. As demands become more complex with increasing age with a need of development towards independence, social difficulties might exacerbate (811). Research suggests that individuals with ASD are at increased risk for psychiatric disorders such as depression, obsessive–compulsive disorder (OCD), and anxiety disorders (12, 13), as well as low adaptive outcomes in adult life (14), which might even cause significant strain on family members (15, 16). The lifetime costs for health care and the loss of productivity per individual with ASD (without intellectual disability) have been estimated to be US$1.4 million in the USA and £0.92 million in the UK (17).

Despite the need for evidence-based interventions for individuals with ASD, few interventions have been rigorously evaluated (11, 1820). Social skills group training (SSGT; see Table 1) (2134) is widely applied as an intervention tool for school-aged children and adolescents with high functioning ASD (HFASD). Reviews conclude that there is some evidence for the efficacy of SSGT in children and adolescents with HFASD, but that more rigorous research is needed to draw robust conclusions (3539). Although recent studies have applied more methodological rigor in terms of randomized controlled trial (RCT) designs, issues of effectiveness remain widely neglected (35) (see Table 2). In addition, conducted RCT studies on SSGT exhibit several weaknesses in study design and reporting of outcomes. These include small sample size, no definition of primary outcome measures, and no information on the follow-up assessment. Furthermore, information about the examined population regarding, for instance, comorbid diagnoses and concurrent pharmacological and other interventions is often not provided (see Table 1 for an overview of previous SSGT studies).


Table 1. Inclusion and exclusion criteria, tolerated comorbidity, recruitment, duration and setting of previous social skills group training trials of autism spectrum disorder
  Inclusion criteria     Recruitment from/by   Duration frequency/intensity Provider characteristics/supervision/training Setting characteristic/no. of settings Treatment fidelity
Reference Location Age M/F Diagnosis IQ Exclusion criteria Comorbidity Intervention (manual)
Baghdadli et al. (74) Montpellier, France 8–12 years 14/0 aAutism (ICD-10) confirmed by ADI-R ADOS VIQ>70 >1 h of travel time between the home and the center; participation in another social skills program; parental or child refusal   The Autism Resources Centre (University Hospital of Montpellier France) Social skills training group-based program (SST-GP) and Leisure Activities Group-based Program (LA-GP) 20 w
Weekly
90 min
Yes/yes/yes Yes/no reported Yes
Beaumont and Sofronoff (62) Queensland, Australia 7.5–11.7 years 44/5 aAS (DSM-IV) confirmed by SSQ-P and CAST IQ≥85     Announcements, Queensland AS support network newsletter, letters The Junior Detective Training Program (JDTP), group social skills training, parent training, teacher handouts, and a computer game 7 w.
Weekly
120 min
Yes/not reported/no reported Yes/no reported Yes
Begeer et al. (63) Amsterdam, The Netherlands 8–13 years 33/3 aAutism, AS, or PDD-NOS (DSM-IV TR), confirmed by SRS and AQ IQ≥70   ADHD Learning disorder Academic Centre for Child and Adolescent Psychiatry, Amsterdam, the Netherlands Manualized theory of mind training (TOMT) (21). Parents were involved in the training 16 w
Weekly
/90 min
Yes/yes/yes Yes/no reported Yes
DeRosier et al. (64) Cary, NC, USA 8–12 years 54/1 aHFA, AS, or PDD-NOS confirmed by SCQ, ASSQ, and CAST IQ≥85 Significant aggressive behavior (CBCL Aggressive Scale T-score >70)   Via local autism professionals, school counselors, pediatricians, and parent support groups Social Skills Group Intervention-High Functioning Autism (S.S.GRIN-HFA): parents were involved 15 w
Weekly
60 min
Yes/no reported/yes Yes/yes Yes
Frankel et al. (65) Los Angeles, CA, USA 6–11 years 58/10 aASD using ADOS, ADI-R, and ASSQ VIQ>60 Proscribed psychotropic medication; clinical seizure disorder; thought disorder   UCLA Outpatient Clinic Assessment Core of the UCLA Center for Autism Research and Treatment Parent-assisted Children’s Friendship Training (CFT) (22). Parents are integrated within separate concurrent sessions 12 w
Weekly
60 min
Yes/no reported/yes Yes/no reported Yes
Koenig et al. (66) New Haven, CT, USA 8–11 years 34/10 aPDD confirmed by ADOS, SCQ, and PDDBI IQ≥70 Severe psychiatric problems, aggression, self-injury, or oppositional behavior   Subjects were recruited through a university clinic Intervention based on social learning theory and principles of behavior theory and therapy, with the use of peer tutors 16 w
Weekly
75 min
Yes/no reported/no reported Yes/no reported Yes
Koning et al. (75) Alberta, Canada 10.3–12.2 years 17/0 aASD (DSM-IV) confirmed by ADOS NV IQ≥80 Significant behavioral difficulties; parental difficulty with English   Local autism society newsletter and a local autism clinic database CBT principles based on components of the (23) model, (24) manual, and (25, 26) 15 w
Weekly
120 min
Yes/no reported/no reported No reported/no reported Yes
Laugeson et al. (67) Los Angeles, CA, USA 13–17 years 28/5 aHFA, AS, or PDD-NOS VIQ≥70 Major mental illness (bipolar disorder, schizophrenia, psychosis); hearing, visual, or physical impairments   Regional centers and schools in Southern California and UCLA outpatient clinics Program for the Education and Enrichment of Relational Skills, PEERS (27) 12 w
Weekly
90 min
Yes/yes/yes No reported/no reported Yes
Lerner and Mikami (76) Charlottesville, VA, USA 11 years 13/0 aHFA confirmed by SCQ and SRS       Community-based lists of families of children who had received a previous HFA diagnosis Socio-Dramatic Affective Relational Intervention (SDARI) and Skill streaming, which focuses on didactically training the discrete steps of social interaction (28) 4 w
Weekly
90 min
Yes/yes/yes No reported/no reported Yes
Lopata et al. (68) Buffalo, NY, USA 7–12 years 34/2 aHFA, AS, and PDD-NOS IQ≥70 Severe physical aggression   Public announcements over a period of 6 months Social skills, face-emotion recognition, interest expansion, and interpretation of non-literal language, along with weekly parent training (29, 30) 5 w
Daily
70-min
Yes/no reported/yes Yes/no reported Yes
Schohl et al. (69) Wisconsin, USA 11–16 years 47/11 aASD using ADOS VIQ≥70 Major mental illness (bipolar disorder, schizophrenia, or psychosis); hearing, visual, or physical impairments Social anxiety Local intervention agencies, autism support groups, and an in-house waiting list for PEERS treatment Program for the Education and Enrichment of Relational Skills, PEERS (31) 14 w
Weekly
90 min
Yes/yes/yes Yes/no reported Yes
Solomon et al. (72) Davis, CA, USA 8–12 years 18/0 aHFA, AS, or PDD-NOS confirmed by ADOS and ADI-R IQ>75 Serious conduct problems Depression From the M.I.N.D. Institute website, M.I.N.D. Institute clinic, pediatricians and child psychiatrists, and local parent support groups Social skills group training (awareness of emotions; face processing; theory of mind; conversation; problem solving) detailed in appendices 20 w
Weekly
90 min
Yes/yes/no reported Yes/no reported Yes
Thomeer et al. (70) Buffalo, NY, USA 7–12 years 30/5 aHFA, AS, and PDD-NOS, confirmed by ADI-R IQ>70 Physical aggression     Skillstreaming Include modeling, role-playing, performance feedback, social interaction, face-emotion recognition, non-literal language skills, and expand interests (32) 5 w
Daily
70 min
Yes/no reported/yes Yes/no reported Yes
White et al. (73) Virginia, USA 12–17 years 23/7 aASD confirmed by ADOS and ADI-R VIQ≥70 Serious behavioral problems; a primary diagnosis of OCD, PD, or Agoraphobia SoP
GAD
SP
SAD
OCD
PD/Agor
PTSD
University-affiliated clinic specializing in the treatment of ASD, schools, and media advertisements Multimodal Anxiety and Social Skills Intervention (MASSI). CBT program which has tree modalities: individual, group and parent group. (33) 14 w
1–2 weekly
Individual 60–70 min
Group sessions
75 min
Yes/yes/yes No reported/no reported Yes
Yoo et al. (71) Seoul, South Korea 12–18 years 44/3 aPDD-NOS, AS, or autistic disorder (DSM-IV-TR) confirmed by ADOS and ADI-R VIQ>65 Major mental illness (schizophrenia, bipolar, depressive, or psychotic disorder); aggressive, oppositional behavior; hearing, visual, or physical disabilities Anxiety depression Child and adolescent psychiatric clinics at Seoul National University Hospital, Gil Hospital, Kyung Hee University Medical, Korean Academy Program for the Education and Enrichment of Relational Skills, PEERS®(34), Korean version (71) 14 w
Weekly
90 min
Yes/yes/yes Yes/no reported Yes
ADOS: The Autism Diagnostic Observation Schedule; ADI-R: The Autism Diagnostic Interview-Revised; ADHD: Attention Deficit Hyperactivity Disorder; AS: Asperger Syndrome; ASD: Autism Spectrum Disorder; ASSQ: Autism Spectrum Screening Questionnaire; AQ: Autism Spectrum Quotient; CAST: Childhood Asperger Syndrome Test; CBCL: Child Behavioral Checklist; CBT: Cognitive Behavior Therapy; DSM-IV: Diagnostic and Statistical Manual of Mental Disorders IV; GAD: Generalized Anxiety Disorder; HFA: High-Functioning Autism; ICD-10; International Classification of Diseases-10; IQ: Intelligence Quotient; VIQ: Verbal Intelligence Quotient; NV IQ: Non-verbal Intelligence Quotient; OCD: Obsessive–Compulsive Disorder; PD: Panic Disorder; PD/Agor: Panic Disorder with Agoraphobia; PDD: Pervasive Developmental Disorders; PDDBI: Pervasive Developmental Disorders Behavior Inventory; PDD-NOS: Pervasive Developmental Disorders Not Otherwise Specified; PTSD: Post-Traumatic Stress Disorder; SAD: Separation Anxiety Disorder; SCQ: Social Communication Questionnaire; SoP: Social Phobia; SP: Specific Phobia; SRS: Social Responsiveness Scale; SSQ-P: Social Skills Questionnaire-Parent version
aClinical diagnosis or previous diagnoses.


Table 2. Outcome measures, results, effect sizes, timing of assessments, and quality of outcome measures in previous social skills group training trials of autism spectrum disorder
    Results   Quality of outcome    
Reference Primary/secondary measures Intervention group, mean (SD/IQR) Control group, mean (SD/IQR) Differences and effect size between the groups Timing of outcome measurement Multiple sources Blinded observations raters/assessment Reliability or validity of outcome measure Report on incentives Randomization process
Baghdadli et al. (74) Child: DANVA2 (AF)a and (CF)a
Parent: HRQOL; Kidscreen-27 Parental Form
DANVA2 (AF)
Pre: 7.5 (6;9)
Post: 6.5 (4;7)
DANVA2 (CF)
Pre: 6.5 (3;9)
Post: 6.0 (4;7)
Pre: 7.0 (5;8)
Post: 6.0 (4;10)
Pre: 5.0 (4;7)
Post: 6.0 (3;9)
p=0.64
d=−0.3
p=0.62
d=−0.3
T1: 30 days before the treatment
T2: 30 days after the last session
Yes No/DANVA2 No No Yes
Beaumont and Sofronoff (62) Child: APEFE; APEPC; James and the Maths Test; Dylan is Being Teased
Parent and teacher: SSQ-P, ERSSQ-P
SSQ-P
Pre: 25.30 (7.43)
Post: 38.08 (9.84)
Pre: 23.16 (9.05)
Post: 25.11 (7.91)
η2=0.37 T1:
T2: 6-week follow-up,
T3: 5 months follow-up
Yes No/no Yes No No
Begeer et al. (63) Child: Self-Reported, ToM test, LEAS-C
Empathy, Parent: CSBQ
ToM
Pre: 50.89 (5.31) Post: 58.21 (4.00)
Pre: 54.00 (5.93)
Post: 58.00 (5.78)
p=0.03   Yes No/no No No No
DeRosier et al. (64) Child: Social Dissatisfaction Questionnaire and Social Self-efficacy Scale
Parent: SRS, ALQ, Social Self-efficacy Scale
SRS
Communication
Standardized change scores over time
0.38 (1.07)
Communication
Standardized change scores over time
0.50 (0.78)
d=−0.94 T1: 2 weeks before the intervention
T2: within 2 weeks after the treatment
Yes No/no Yes No No
Frankel et al. (65) Child: The Loneliness Scale, Piers-Harris Self-Concept Scale
Parent and Teacher: QPQ, PEI
Staff: SSRSa
SSRS-P Self-control
Pre: 10.2 (3.4)
Post: 12.2 (2.9)
Pre: 9.0 (3.9)
Post: 10.1 (3.7)
p<0.05 T1: Just prior the treatment
T2: 12 weeks after the treatment
T3: after 1–5 years
Yes No/no Yes No Yes
Koenig et al. (66) Parent: CGI,a SCI SCI–pro-social index
Pre: 2.52 (0.48)
Post: 2.83 (0.53)
CGI-I
Pre: 2.67 (0.64)
Post: 2.77 (0.56)
No much improved or very much improved
p=0.52 T1: Before
T2: After the treatment (timing was no specified)
No No/CGI No Yes Yes
    16 of 23 showed much improved or very much improved                
Koning et al. (75) Child: Social Knowledge Parent: SRS, Vineland-II
socialization Staff: CASP, PIM
SRS
Pre: 80.71 (5.22)
Post: 74.85 (11.61)
Pre: 85.00 (6.39)
Post: 79.62 (9.53)
p=0.92
d=0.00
T1: Before
T2: After the treatment, and control group after 12 weeks
  Yes/CASP, PIM Yes Yes  
Laugeson et al. (67) Child: FQS, QPQ
Parent: SSRS, QPQ
Teacher: SSRS
Tests: TASSK
SSRS-P
Pre: 80.2 (8.8) Post: 89.7 (12.1)
Pre: 77.9 (12.1)
Post: 79.8 (11.7)
p<0.05 T1: One week prior to receiving the intervention
T2: After the last night of the intervention (week 12)
Yes No/SSRS teachers Yes Yes No
Lerner and Mikami (76) Parent: SCQ,a SRS,a SSRS-P,a
Teacher: SSRS-T
Staff: SIOSa
Peers: Sociometricsa
SSRS-P
Pre: 77.57 (8.70)
Post: 79.71 (9.59)
Pre: 82.33 (17.76)
Post: 82.33 (15.65)
p>0.593 4 T1: After the first
T2: After the last sessions, and observations during sessions
Yes Yes/SCQ, SRS, SSRS-Parents; SIOS, staff Yes No No
Lopata et al. (68) Child: SKA,a DANVA2, CASL Idiomatic Languagea
Parent: SRS,a ASC,a BASC-2-PRSa withdrawal
BASC-2-PRSa: social skills
Staff: SRS, ACS, BASC-2
SRS
Pre: 79.94 (11.02) Post: 73.67 (11.42)
Pre: 81.12 (13.78)
Post: 82.53 (13.77)
p<0.001
d=−0.102
T1: 5 days prior to beginning treatment
T2: 5 days after treatment
Yes No/no Yes No Yes
Schohl et al. (69) Child: TASSK, QSQ-A-R, SIAS, FQS
Parent: SRS, SSRS, QSQ-P-R,
Teacher: SSRS-T, SRS
SRS
Pre: 101.17 (23.08) Post: 79.12 (20.21)
Pre: 106.28 (21.62)
Post: 98.55 (22.53)
p=0.005 T1: At week 1
T2: After 14 weeks for both groups
Yes No/SSRS, SRS, teachers No Yes No
Solomon et al. (72) Child: DANVA-2, Strange Stories Task, Faux Pas DANVA-total faces
Age 8–10
Pre: 24.8 (3.1)
Post: 24.0 (2.3)
Adult faces
p<0.05
No reported Yes No/no No Yes No
  Stories Task, TOPS, CDI
Parents: PBL, BDI
Pre: 23.8 (1.3)
Post: 26.6 (1.5)
Age 10–12
Pre: 22.5 (2.9)
Post: 24.8 (3.4)
Pre: 25.2 (3.3)
Post: 23.6 (3.3)
child faces
p<0.05
           
Thomeer et al. (70) Child: SKA,a DANVA-2,a CASLa
Parent: ASC,a SRS,a BASC-2a
SRS
Pre: 83.24 (17.27)
Post: 75.24 (13.54)
Pre: 83.06 (12.61)
Post: 84.29 (13.84)
p<0.001
d=−0.09
T1: 5 days prior to treatment,
T2: 5 days after treatment
T3: 2 to 3 months post treatment
Yes No/no No No No
White et al. (73) Parent: SRS,a CASI-Anxa
Staff: CGI, DD-CGAS, PARS
SRS
Pre: 88.87 (12.32) Post: 74.33 (12.63)
Pre: 85.73 (14.14)
Post: 80 (12.18)
d=1.03 T1: Over a 1-week period
T2: 1 week period
Yes No/CGI, PARS, DD-CGAS, staff Yes No No
Yoo et al. (71) Child: TASSK-R,a QPQ,a K-SSRS,a CDI, STAIC-T and STAIC-S,
Parent: EHWA-VABS,a QPQ,a SRS,a ASDS,a K-CBCL, BDI, STAI-T and STAI-S
Staff: ADOS,a SCQa
ADOS
Pre: 14.30 (3.14)
Post: 13.26 (2.91)
Pre: 14.92 (3.30)
Post: 15.13 (3.51)
p=0.00 T1: One week
T2: After the last session (week 14)
T3: 3 months after the last session
Yes No/ADOS (partially blinded) Yes No Yes
ADOS: The Autism Diagnostic Observation Schedule; ALQ: Achieved Learning Questionnaire; APEFE: Assessment of Perception of Emotion from Facial Expression; APEPC: Assessment of Perception of Emotion from Posture Cues; ASC: Adapted Skillstreaming Checklist; BASC-2: Behaviour Assessment for Children; BDI: Beck Depression Inventory; CASI-Anx: Child and Adolescent Symptom Inventory-4 ASD Anxiety; CASL: Comprehensive Assessment of Spoken Language; CASP: Comprehensive Assessment of Spoken Perception Measure; CDI: The Children’s Depression Inventory; Child and Adolescent Social Perception; CGI: Clinical Global Impressions-Improvement scale; CSBQ: The Children’s Social Behaviour Questionnaire; DANVA2-AF: Diagnostic Analysis of Non-verbal Accuracy 2 (AF, Adult face; CF, Child face); DD-CGAS: Developmental Disabilities Children’s Global Assessment Scale; EHWA-VABS: Korean version of the Vineland Adaptive Behaviour Scale; ERSSQ: Emotion Parents Regulation and Social Skills Questionnaire; FQS: Friendship Qualities Scale; HRQOL: Health-Related Quality of Life questionnaire; IQR: Inter Quartile Range; K-CBCL: Korean Version of the Child Behaviour Checklist; K-SSRS: Korean Version of the Social Skills Rating System; LEAS-C: The Levels of Emotional Awareness Scale for Children; PARS: Pediatric Anxiety Rating Scale; PBL: Problem Behaviour Logs; PEI: The Pupil Evaluation Inventory-Teacher PSI: The Pro-Social Index; PIM: Peer Interaction Measure; QPQ: The Quality of Play Questionnaire; QSQ-P-R: Quality of Socialization Questionnaire-Parent; SCI: Social Competence Inventory; SCQ: Social Communication Questionnaire; SIAS: Social Interaction Anxiety Scale; SIOS: Social Interaction Observation System; SKA: Skillstreaming Knowledge Assessment; SRS: Social Responsiveness Scale; SSQ: Social Skills Questionnaire; SSRS-P: Social Skills Rating System-Parent; SSRS-T: Social Skills Rating System-Teacher; STAI-T and STAI-S: State and Trait Anxiety Inventory; STAIC-T and STAIC-S: State and Trait Anxiety Inventory for Children; TASSK: Test of Adolescent Social Skills Knowledge; TASSK-R: Test of Adolescent Social Skills Knowledge-Revised; ToM: Theory of Mind; TOPS: Test of Problem Solving.
aPrimary outcome.

Most research on family burden associated with ASD suggests that parents show elevated rates of stress, sick leave, depression, and anxiety compared with parents of typically developing children (15, 40). Still another body of literature suggests that parents of children with ASD and other disabilities develop a particular resilience, adopt effective coping strategies for daily problems (41), and achieve feelings of self-efficacy that decrease levels of stress (42). Hence, it seems worthwhile to include family burden in SSGT studies. However, surprisingly little attention has been paid in prior SSGT research on parent stress.

Although intervention research typically examines an average group effect of a treatment, it appears reasonable to examine the influence of participant characteristics on treatment outcomes, in order to facilitate future personalized treatment decisions. However, factors such as sex, age, language level, medical history, cultural background, comorbidity, and genetic background have not been systematically studied as predictors of treatment outcome in the majority of previous SSGT studies. Particularly, therapy genetics have not yet been integrated in SSGT research. Although progress has been made in the area of ASD risk gene identification, and for about 16% of individuals with ASD a specific genetic cause is known (43), those etiological variants have not been systematically examined in treatment studies of ASD as a component affecting treatment response of any ASD intervention technique.

This protocol describes the evaluation of a manual-based SSGT for children and adolescents with HFASD, ‘KONTAKT’. The program was developed and has been piloted in Germany (44). KONTAKT has recently been adapted to Swedish settings and examined for feasibility (45). The results of the German pilot study showed preliminary evidence of improvements in social communication skills following the intervention, and identified that high IQ, good language abilities, as well as severe ASD phenotypes predict positive outcomes. The Swedish pilot study yielded improvements in social interaction, social awareness, and adaptive behaviors both using quantitative and qualitative assessments.

The current study protocol seeks to overcome several of the methodological shortcomings of previous RCTs on SSGT. In addition to the randomized controlled design, the large sample examined, the usage of a manual-based method, well-defined inclusion and exclusions criteria, psychometrically sound outcome measures (for social responsiveness, adaptive behaviors, symptom severity, and parent stress), multiple informants (participants, parents, clinicians, and blinded teachers), computerized randomization, and monitoring of the standard care control treatment, we introduce personalized medicine into SSGT of ASD. To increase the understanding of SSGT treatment mechanisms, moderators and mediators of treatment outcome are explored, especially genetic predisposition, age, IQ, sex, verbal skills, and comorbidity on treatment effects.

Methods

Design

A stratified (age group [children, adolescents], length of treatment [short, long], clinic) randomized controlled naturalistic (embeddedness in obligatory health care) multicenter trial with an active treatment group (manualized SSGT KONTAKT plus treatment as usual [TAU]) vs. a waiting list TAU-only control group, three points of assessment (baseline, post, follow-up), specified inclusion and exclusion criteria, defined primary (blinded and unblinded) and secondary outcome measures.

Participants

All participants are recruited from 14 child and adolescent psychiatric units located in Stockholm and Örebro County (see below) by internal referral and by self-referral through contacting the project coordinator (NCO) or trainers at the centers. Self-referred participants are directed to an available unit based on the participant’s preference (e.g. distance from home). Written consent is obtained from both parents and children after they receive detailed written and verbal information about the treatment content, structure, and time plan in an intake interview. A total of N=288 participants with HFASD and psychiatric comorbidity, namely attention deficit hyperactivity disorder (ADHD), anxiety, and depression, aged 8–17 years are included. The participants are stratified for age group, long and short treatment, and center and then randomly designed to the active KONTAKT (plus TAU) training group (n=144) or TAU-only control group (n=144) (Fig. 1). Randomization is conducted by the research coordinator using computer-generated random numbers. Blocking with randomly varying groups of 4–6 will be used to restrict randomization within the strata. Participants are assessed at baseline, post-treatment, and at 3-month follow-up.

Fig 1

Fig. 1. Trial flowchart.

Inclusion criteria

Participants will be included in the study when the following criteria are met 1) a prior clinical consensus diagnosis of HFASD, as defined by either of the following ICD-10 (46) diagnoses: F84.0, F84.1, F84.5, or F84.9; 2) above cut-off for ASD on the Autism Diagnostic Observation Schedule (47); 3) have an IQ>70 on the Wechsler Intelligence Scale for Children – third or fourth edition (48, 49); 4) have an additional prior clinical consensus diagnosis of ADHD (F90.0 or F90.8), anxiety (F40, F41, or F43), or depression (F32 or F33). The comorbid conditions are corroborated by results from the Schedule of Affective Disorders and Schizophrenia for School-Aged Children [K-SADS] (50).

Exclusion criteria

Participants with the following prior clinical consensus diagnoses are excluded from the current trial: conduct disorder (F91), hyperkinetic conduct disorder (F90.1), antisocial personality disorder (F60.2), borderline personality disorder (F60.3), and any form of schizophrenia or related disorders (F20–F29). Moreover, individuals with clinically assessed self-injury, low intrinsic motivation, and insufficient Swedish language skills are excluded.

Manualized SSGT treatment program KONTAKT

KONTAKT (German and Swedish for ‘contact’, no acronym) is a manual-based SSGT for children and adolescents with HFASD. KONTAKT uses principles of cognitive-behavioral therapy, behavioral activation, observational learning, psychoeducation, and social cognition training. The groups meet weekly, 1 h for children and 1½ h for adolescents. Each group consists of 4–8 participants and two trainers. For the ongoing KONTAKT SSGT RCT trial, 12 sessions (short treatment) and 24 sessions (long treatment) are fully standardized. Prior to the current study protocol, the original German KONTAKT manual was translated into Swedish by a group of professional translators and experienced Swedish clinicians working in child and adolescent psychiatry (51). The KONTAKT manual has three supplementary workbooks (for participants, parents, and trainers) [unpublished, in preparation] in order to enhance clinical feasibility as well as treatment integrity and adherence. The workbook for participants consists of homework assignments, which are tailored based on the participants own and prioritized treatment goals. Among the goals of KONTAKT are to improve the participant’s initiation of social overtures, conversation skills, understanding of social rules and social relationships, skills to identify and interpret verbal and non-verbal social signals, conflict management, learning of coping strategies, and self-confidence in social context. The program has more and less structured elements (Table 3). The structured parts include sessions to convey knowledge of common social rules and norms as well as conflict solving strategies, group discussions, social play exercises, emotion recognition and expression training, role-plays, and homework assignments. A rather non-structured format is ‘Fika’ (traditional Swedish coffee break/snack-time) in the middle of each training session, which offers a possibility for social communication in a casual (but sheltered) social situation. Parent involvement (e.g. three information meetings) as well as teacher cooperation is also embedded into the KONTAKT program.


Table 3. KONTAKT treatment formats and objectives
Treatment format Examples/descriptions Objectives
Opening the session Say hello to each other. Give an account of an experience from the past few days and of one’s mood at the beginning of the session
‘I give the word to …’ (name, eye-contact)
Warm-up activity, contact initiation, promotion of interaction between group members, promote eye-contact
Homework assignment follow-up Reinforce and give feedback on completed assignment. Troubleshooting if necessary
Group exercise Role play Practical solutions and strategies for difficult social situations
  Group activities (e.g. baking together) Foster a feeling of group cohesion, practice cooperation, and social skills
  Social interaction games (e. g. spin the bottle) Basic interaction and communication games, cooperation, recognition of non-verbal signals, eye-contact
  Affect recognition, FEFA (computer-based) Recognition and interpretation of facial expressions
Snack time The children interact in a non-structured situation. The group leaders encourage social skills at snack-time Practice small-talk and turn-taking in unstructured conversation
Group discussion Examples of discussion topics: What is ASD? How can I tell what somebody else is feeling? How do I initiate a conversation? Exchange experiences, social cognition, social
relationships
Homework assignment Setting individual goals
‘Analyze a difficult situation’
‘Evaluate alternative coping behaviors’
‘Make an appointment with a classmate’
Generalization of skills to everyday situations
Closing the session Recap of the day – what has been good or less good? Participants give suggestions for improvement. Participants take turns the same way as in the opening Evaluation of sessions, promotion
of interaction between group members
FEFA=Frankfurt Test and Training for Facial Affect Recognition.

Treatment-as-usual (TAU), standard care

The waiting list control group not receiving KONTAKT only receives any kind of ongoing TAU in standard care that is delivered by the participating departments or other caregivers. TAU will be monitored in detail and usually consists of pharmacological treatment, individual psychological treatment (e.g. CBT), and general counseling or rehabilitation interventions (typically parental education or the prescription of weighted blankets for co-existing sleep problems) (52).

Recruitment and training centers

The study is conducted at 14 regular healthcare child and adolescent psychiatry clinical outpatient units: 11 departments of Child and Adolescent Psychiatry, Stockholm County Council (Brommaplan, KIND, Danderyd, Jakobsberg, Mellanvård Nordost, Mellanvård Sydväst, Solna, Sollentuna, Södertälje, Skärholmen, and Täby), one private child and adolescent psychiatry clinic in Stockholm (Prima Barn, Järva), and one child and adolescent psychiatric clinic in Örebro County (Child and Adolescent Habilitation Services, BUH).

Primary outcome measures

Social Responsiveness Scale

Social communication is assessed by blinded school teachers (blinding ensured by blindness questionnaire) and parents using the Social Responsiveness Scale (SRS) (53). The SRS is a dimensional 65-item questionnaire assessing autism traits in children and adolescents aged 4–18 years. Items are rated on a 0–3 Likert scale and compose five treatment subscales: social awareness, social cognition, social communication, social motivation, and autistic mannerisms. Total scores range between 0 and 195 with increasing values indicating increasing severity of autistic traits. The expected value for individuals with a primary diagnosis of ASD is approximately 100, and about 25 in typical development (53). The original SRS and cross-cultural adaptations have shown excellent psychometric properties (54). As recommended for research, SRS raw scores are used in this study for total and treatment and subscales.

Secondary outcome measures

Adaptive Behavior Assessment System II

Adaptive behavior capacities are measured by parent and school teacher ratings using the Adaptive Behavior Assessment System II (ABAS-II), a scale of adaptive functioning that indexes real-word abilities and disabilities, and has demonstrated usefulness in studies of ASD (55). The ABAS-II assesses a participant’s skills across a range of domains (communication, social, community use, functional academics, school/home living, health and safety, leisure, self-care, and self-direction). Four composite scores are derived: general adaptive composite, conceptual, social, and practical.

Developmental Disabilities Children’s Global Assessment Scale

The Developmental Disabilities Children’s Global Assessment Scale (DD-CGAS) (56) is an instrument used by clinicians to rate patients’ global adaptive functioning. The scale ranges from ‘1’ indicating an extremely and consistently reduced ability to ‘100’ indicating excellent functioning in all areas of life (e.g. at home, school, and in social relations). Scores below 70 on the DD-CGAS indicate clinically relevant atypical functioning. The DD-CGAS is a modified version of the standard CGAS to better fit children and adolescents with ASD. The scale has previously been translated into Swedish and was successfully evaluated for psychometric properties (57).

OSU Autism Clinical Global Impression – Severity

The OSU Autism Clinical Global Impression – Severity (58) is a clinician-based rating scale to estimate current severity of general psychopathology. The global clinical impression is rated on a 7-point scale for ASD and other symptom severity with ‘7’ indicating extremely severe symptomatology and ‘1’ indicating no sign of clinical symptomatology. It is a modified version of the standard CGI to better fit individuals with ASD and has been adapted to Swedish clinical settings (57).

Perceived Stress Scale

The Perceived Stress Scale (59) is a 14-item global assessment of an individual’s perception of current psychological stress. Each item is rated on a 5-point scale. Scores are calculated after reverse keying positive items and totaling the scores. Possible total scores range from 0 to 52, a higher score indicating greater stress.

Children in Stress

The Children in Stress (CiS) (60) is a 21-item self-report questionnaire to assess stress in children. The CiS has demonstrated solid correlations with the Beck Youth Inventories of Emotional and Social Impairment, and good internal consistency.

Therapy genetics

Saliva samples for DNA extraction are collected from each of the consenting participants using the Oragene DNA OG500 kit (DNA Genotek). Genome-wide methods such as single-nucleotide polymorphism microarrays and next-generation sequencing will be used to identify any causative genetic mutations in the participants as well as to investigate variations/burden in specific genes and gene sets that could be used as reliable genetic predictors of the SSGT response.

Sample size estimation and statistical analyses

The sample size calculation refers to the two primary outcome endpoints, change in SRS total scores and subscales for parent and blinded teacher ratings between baseline and follow-up assessment, in the Intention to Treat (ITT) population. Concluded from the open German pilot study (44), the current study sought high power (1−β=90%) to detect even small to medium effects (Cohen’s f=0.20) at conventional error probability (α=5%) for social communication improvement on the SRS following KONTAKT (plus TAU) versus TAU only. Applying this objective in a MANOVA for repeated measures (within-between interaction) in the ITT yields a resulting total sample size of N=288 (2×(n=144)) (G-Power 3.1.7). Mixed-effect models will be used to investigate the change in social communication skills over the treatment period by using parent- and teacher-rated SRS scores as a dependent variable. The model is specified by using time (pre, post, or follow-up), group (KONTAKT and TAU vs. TAU), and the interaction time*group as fixed effects, with a random intercept for each study group (child and adolescent group). All data provided by participants will be included in the analyses. Data will be tested for normality and homogeneity of variance. To verify that the treatment group and control groups are comparable for continuous and categorical demographic variables at pretreatment, a series of independent sample t-tests and chi-square tests will be conducted. As for primary outcomes, analyses for secondary outcomes (changes in adaptive behavior, clinical severity, and perceived stress) will be conducted according to ITT principles. To analyze for the significance of potential factors predicting outcomes (age, IQ, language abilities, sex, comorbidity, and genetic variants) in the active KONTAKT training group, these are run in logistic regression to explain dichotomized (by median-split) SRS outcomes as dependent variable.

Ethical approval and trial registration

All parts of the study are approved by the Regional Ethical Review Board in Stockholm (registration number 2012/385-31/4). The study is registered in Clinical Trials.gov [NCT01854346].

Discussion

Efficacy and effectiveness

Most published SSGT research so far has focused on treatment efficacy. Reviews of SSGT studies conducted in 2007 and 2008 consistently recommended improving research quality in terms of using RCT designs, manualized programs, and larger sized samples (10, 38). Another more recent review conducted in 2012 summarized five RCT studies, indicating low-to-moderate evidence for SSGT, but still concluded the need for better powered studies to enable drawing robust conclusions (11). Despite definite methodological improvements of studies and increasing support of SSGT efficacy in the last 5 years (36), the effectiveness of conducted studies remains unclear (35, 61). The current protocol describes the largest sized RCT of SSGT to date using a manualized program. Our study is strictly embedded into obligatory clinical care routines, uses regular clinical personnel, and patients with complex HFASD phenotypes. Taken together, this is likely to lead to results of both high efficacy and effectiveness.

Sample size

A frequent methodological flaw of previous SSGT research has been too small sample size to reach sufficient power to detect differences and endorse generalizations. Nine studies had more than 25 participants (4857), and no study had a sample size exceeding N=70. Larger samples are needed to allow for better control over subject variability, thereby increasing both internal and external validity. In this study, we examine by far the largest sample within a SSGT trial to date (N=288).

Description of eligible population

Few studies provided information of clinical phenotypes beyond primary diagnosis of the eligible population, for instance psychiatric comorbidity has not been consequently reported (63, 69, 7173). The latter is unfortunate as secondary psychiatric symptoms are known to be the rule rather than the exceptions in ASD (e.g. depression, OCD, anxiety disorders) and might influence outcomes (12, 13). We include HFASD children and adolescents with common psychiatric comorbidities, which is typical for clinically referred populations, and investigate their effect on outcomes.

Treatment as usual

A limitation of the current and many other previous SSGT studies is the lack of an active control group. Waiting list controls in this protocol receive standard care only. However, TAU in this study is closely monitored and registered, and likely not to reflect inactivity, but in most cases a combination of several other interventions, predominantly pharmacological treatment and individual CBT. Moreover, as the study is embedded into standard care routines provided in Stockholm and Örebro County, and the background aim of the study is to investigate whether KONTAKT adds to existing care, this design seems justified for the purpose.

Manualized programs

The use of manualized SSGT has been recommended recurrently (3538). There have been improvements in the reporting of the duration and frequency, intensity, and treatment fidelity of SSGT (6276). The KONTAKT program evaluated here is a manualized treatment that has been evaluated in two pilot studies (44, 51). The Swedish version was specifically adapted in order to enhance cross-cultural transferability. Furthermore, workbooks for participants, trainers, and parents have been generated to increase treatment standardization and adherence.

Outcome measures

Only half of the SSGT studies published so far reported primary outcome measures (65, 66, 68, 70, 71, 73, 74, 76). There is no consensus on which outcome measures to use in studies of SSGT. The most frequently used outcome measure in SSGT research is the SRS (64, 6870, 73, 76), which is also applied in this protocol as primary outcome measure. Aside from unblinded parent rating, this study, for one of the first times, uses blinded teacher ratings, which markedly increases the scientific rigor of the findings and reduces the risk of bias (38). Our study also reports the stability of effects over time using a 3-month follow-up assessment. Only a minority of SSGT studies reported the follow-up effect of group*time (62, 64, 68, 70, 73, 75).

Multicenter setting

An aspect limiting the generalizability of many study findings is single center setting (35). Only two studies reported the number of settings (64). The majority of more recent SSGT RCT studies were conducted in specialized university-based treatment clinics. Only a few studies were implemented in common community-based settings, with the intervention being delivered by practitioners. To examine the effectiveness of KONTAKT, we are conducting a multicenter study including a total of 14 community-based clinical units and the majority of participants recruited via regular health care.

Implication of the study

This study is the largest randomized controlled multicenter trial for HFASD to date conducted in regular clinical settings, which allows evaluating the intervention in naturalistic settings and a high degree of generalizability. The results of this study will therefore considerably improve the evidence base (both efficacy and effectiveness) of treatment options in HFASD and psychiatric comorbidity and show whether long SSGT is superior to short SSGT or equally effective, which provides important information to policymakers and healthcare providers in terms of economy and resource planning decisions. In addition, moderator analyses and therapy genetics will make possible more individualized tailored treatment decisions to achieve the best health gain, minimizing invaluable action.

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About The Authors

Nora Choque Olsson

Sweden

Kristiina Tammimies

Sweden

Sven Bölte

Sweden

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