Evaluating the Efficacy and Effectiveness of SCOPE - RCT

Study Overview
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Brief Summary
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The study will entail an evaluation of the feasibility, acceptability, efficacy and effectiveness of SCOPE coach supported internet-delivered psychoeducative program using a randomized controlled design in a clinical health care context. An estimated n=175 will be needed to enable block randomisation according a 2:1:1 ratio to: 1) SCOPE internet-based psychoeducation intervention, 2) Self-study controls, who receive eight weekly emails containing informative and relevant websites about Autism Spectrum Disorder (ASD), 3) Wait-list controls.

Detailed Description
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The internet-delivered intervention SCOPE was developed using a participatory research approach, i.e. in cooperation with the target group. SCOPE has eight ASD theme modules and weekly contact with an experienced clinician (coach) via a message function within the Swedish national platform for internet-delivered treatment (1177.se e-services). The three treatment arms means that the self-study controls as well as the wait-list controls will have the option to take part of SCOPE the following semester after having completed the data collection process. The assessment of eligibility is conducted on the national platform for internet-delivered interventions using a web camera application or phone interview. The intake assessment covers depression symptoms and suicidality using MADRS-R, functional impairment using WHODAS 2.0 (WHO), and validation of autism core symptoms using OSU Autism and Social Responsiveness Scale. Treatment expectancy and satisfaction will be measured using the Treatment Credibility Scale (see outcome measures) and an evaluation of each module.The criteria for feasibility were (1) attrition should be less than 40% and (2) the participants should attend at least 75% of the sessions. Efficacy-related measures will be gained through the primary outcome of improved knowledge about ASD. Secondary outcomes are mental health: symptoms of anxiety and depression; acceptance of diagnosis; and quality of life. In addition, measures of treatment credibility are also completed by the coaches. The measures will be analysed using a series of repeated measures ANOVAs (rmANOVAs) to analyse differences between treatment arms. The recommended first-line intervention for ASD is psychoeducation. Psychoeducational interventions for transition-aged autistic youth have a very limited evidence base. Therefore, the effect of psychoeducation for the target group is difficult to discern, the current study would contribute significantly to the research field. The findings will be important especially as psychoeducation is a clinically common intervention, provided in a non-standardized way and without sufficient information of its effects. Recruitment commenced during the autumn of 2016 and was completed in december 2020. Final n=144.

Official Title
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Efficacy and Effectiveness of SCOPE for Intellectually Able Youths With Autism Spectrum Disorder- a Randomized Controlled Study

Conditions
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Autism Spectrum Disorder, Transition

Intervention / Treatment
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* Other: SCOPE
* Other: Self-study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed autism spectrum disorder with IQ in the average range (>70) (diagnosed in accordance with the DSM or ICD-10 diagnostic manuals) relevant age group (16 to 25 years) active participation in the eight-week program sufficient Swedish language proficiency ability to log on and utilize an internet-based platform Exclusion Criteria: current substance misuse (including the past three months) suicidal ideation, diagnosed with intellectual disability (according to DSM or ICD), diagnosed with traumatic brain injury (e.g., stroke), other severe psychiatric disorders (e.g., psychosis) or adverse psychosocial circumstances (e.g., being homeless) that would render participation unlikely or impossible.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCOPE<br>Participants allocated to SCOPE, will receive an internet-based psychoeducation intervention, eight weeks of ASD-theme modules with coaching. | Other: SCOPE<br>* SCOPE is a internet-delivered, coach-guided, psychoeducational intervention, intended to serve as a first-line intervention for intellectually able adolescents and young adults with ASD. The SCOPE program is based on information comprising neuropsychology, pedagogy, and also interdisciplinary clinical experience regarding ASD. The content is aimed at providing information about typical and specific impairments of ASD, as well as the associated strengths.<br>|
| Active Comparator: Self-study<br>Participants allocated to self-study will receive eight weekly emails containing informative and relevant websites about ASD. The emails are accessed on the same platform as the experimental condition (SCOPE), no active contact with the coaches is available. | Other: Self-study<br>* Active control consisting of directed self-studies on internet.<br>|
| No Intervention: Wait-list controls/Treatment as usual<br>Participants allocated to wait-list will receive prompts to answer outcome measures but otherwise no other contact with the study coordinators or coaches. Participants may receive treatment as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores on the ASD Knowledge Quiz | 16 questions about general knowledge about ASD. The questions are based on the eight modules in the interventions. | Change in knowledge measured at baseline, immediately after the intervention and at three month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale | Has 14 items scored 0 (Often ) - 3 (Seldom), subsequently summarized for an overall score; high scores indicate higher levels of depression or anxiety. | Measured at baseline, immediately after the intervention and at three month follow-up | 
| Acceptance and Action Questionnaire (AAQ-II) | Acceptance of the diagnosis was estimated, using a modified version of the AAQ-II. The current version focuses on acceptance of having an ASD diagnosis, using a seven-item scale ranging from 1 (Never) to 7 (Always), and was then summarized for an overall score; high scores indicate low acceptance of the diagnosis. The item wording after adjustment to the current study were: (1) My diagnosis makes it difficult for me to lead a life I could value; (2) I am afraid of my diagnosis; (3) I worry about not being able to control my worries and my feelings regarding my diagnosis; (4) My diagnosis prevents me from leading a fulfilling life; (5) My diagnosis creates problems in my life; (6) I feel uncomfortable with my diagnosis; (7) My diagnosis gets in the way of my success. | Measured at baseline, immediately after the intervention and at three month follow-up | 
| Brunnsviken Brief Quality of Life Inventory (BBQ) | A measure estimating quality of life using 12 items: using a scale ranging from 1 (Not at all) to 4 (Very much), subsequently summarized for an overall score; high scores indicate high satisfaction with life. | Measured at baseline, immediately after the intervention and at three month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Young adults, Psychoeducation, Internet-based intervention, Adolescents