KONTAKT© in Australian Adolescents on the Autism Spectrum: Protocol of a Randomized Control Trial

BACKGROUND: Individuals diagnosed with Autism Spectrum Disorder (ASD) experience impairing challenges in social communication and interaction across multiple contexts. While social skills group training (SSGT) has shown moderate effects on various sociability outcomes in ASD, there is a need for (i) replication of effects in additional clinical and cultural contexts, (ii) designs which employ active control groups, (iii) calculation of health economic benefits, (iv) identification of the optimal training duration, and (v) measurement of individual goal and quality of life outcomes. METHOD: With the aim of investigating the efficacy and cost-effectiveness of a SSGT, KONTAKT©, a two-armed randomized control trial with adolescents aged 12 to17 years (N=90) with ASD and an intelligence quotient (IQ) of over 70 will be undertaken. Following stratification for centre and gender, participants will be randomly assigned to either KONTAKT© or to an active control group, a group-based cooking program. Participants will attend both programs in groups of 6 to 8 adolescents, over 16 one and a half hour sessions. The primary outcome examined is adolescent self-rated achievement of personally meaningful social goals as assessed via Goal Attainment Scaling during an interview with a blinded clinician. Secondary outcomes include adolescent self-reported interpersonal efficacy, quality of life, social anxiety, and loneliness, face emotion recognition performance and associated gaze behaviour, and parent proxy reports of autistic traits, quality of life, social functioning, emotion recognition and expression. Cost-effectiveness will be investigated in relation to direct and indirect societal and health care costs. DISCUSSION: The primary outcomes of this study will be evidenced in the anticipated achievement of adolescents’ personally meaningful social goals following participation in KONTAKT© as compared to the active control group. This design will enable rigorous evaluation of the efficacy of KONTAKT©, exercising control over the possibly confounding effect of exposure to a social context of peers with a diagnosis of ASD. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12617001117303, registered 31 July 2017, anzctr.org.au; ClinicalTrials.gov: NCT03294668 registered 22 September 2017, https://clinicaltrials.gov.