Journal Article

KONTAKT© for Australian adolescents on the autism spectrum: protocol of a randomized control trial

Falkmer, Marita, Coco, Christina, Lenhard, Fabian, Chen, Nigel T. M., Alach, Tasha, Fridell, Anna, Milne, Kelly, Girdler, Sonya, Afsharnejad, Bahareh, Bölte, Sven, Black, Melissa H.

2019

Overview

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 (1) replication of effects in additional clinical and cultural contexts, (2) designs that employ active control groups, (3) calculation of health economic benefits, (4) identification of the optimal training duration, and (5) measurement of individual goals and quality of life outcomes. Method/design With the aim of investigating the efficacy and cost-effectiveness of a SSGT, KONTAKT©, a two-armed randomized control trial with adolescents aged 12–17 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 programme. Participants will attend both programmes in groups of 6–8 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 the Goal Attainment Scaling during an interview with a blinded clinician. Secondary outcomes include adolescent self-reported interpersonal efficacy, quality of life, social anxiety, loneliness, face emotion recognition performance and associated gaze behaviour, and parent proxy reports of autistic traits, quality of life, social functioning, and emotion recognition and expression. Cost-effectiveness will be investigated in relation to direct and indirect societal and healthcare 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 on 31 July 2017. anzctr.org.au ClinicalTrials.gov, NCT03294668 . Registered on 22 September 2017. https://clinicaltrials.gov

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: adolescent / Adolescents / Anxiety / Australian / Autism / Autism spectrum disorder / Biomedicine / child / Child development / clinical effectiveness / clinical outcome / Clinical trials / Communication / controlled study / cooking / cost effectiveness analysis / emotion / face / female / gaze / gender / Goal Attainment Scale / Health aspects / health care cost / Health care costs / Health Sciences / human / intelligence quotient / Intervention / interview / KONTAKT / loneliness / major clinical study / male / Medical economics / Medicine / Medicine & Public Health / parent / peer group / Peers / Proxy / Quality of life / randomized controlled trial / rating scale / Retirement benefits / school child / self concept / Skill development / Social aspects / Social goals / social interaction / Social skills / social skills group training / Statistics for Life Sciences / Study Protocol / Teenagers / Training