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Completed

NCT Number: NCT03665363

Evaluating the Efficacy and Effectiveness of SCOPE - RCT

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.

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Key information

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Habilitering & Hälsa

Stockholm, Stockholm County, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCOPE

Other

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.

Self-study

Other

Active control consisting of directed self-studies on internet.

Primary outcomes

  1. Change in scores on the ASD Knowledge Quiz

    Time frame: Change in knowledge measured at baseline, immediately after the intervention and at three month follow-up

    16 questions about general knowledge about ASD. The questions are based on the eight modules in the interventions.

Secondary outcomes

  1. Hospital Anxiety and Depression Scale

    Time frame: Measured at baseline, immediately after the intervention and at three month follow-up

    Has 14 items scored 0 ("Often" ) - 3 ("Seldom"), subsequently summarized for an overall score; high scores indicate higher levels of depression or anxiety.

  2. Acceptance and Action Questionnaire (AAQ-II)

    Time frame: Measured at baseline, immediately after the intervention and at three month follow-up

    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".

  3. Brunnsviken Brief Quality of Life Inventory (BBQ)

    Time frame: Measured at baseline, immediately after the intervention and at three month follow-up

    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.

Other outcomes

  1. The Treatment Credibility Scale (TCS)

    Time frame: Measured at baseline, immediately after the intervention and at three month follow-up

    As a measure of feasibility TCS is used to measure the expectation of improvement and treatment credibility. The TCS is a visual analogue scale rated from "Low credibility"/ "Not at all" (0) to "High credibility"/"Very much" (10) and the score calculated is a mean of all items. The TCS was administered after providing thorough information and presentation of the treatment content at baseline and after completion of the treatment. The item wording after adjustment to the current study were: (1) How logical does SCOPE seem to you?; (2) How confident are you that you will learn more about autism from SCOPE?; (3) Would you recommend SCOPE to a friend with ASD?; (4) How successful do you feel this type of program would be in teaching about other diagnoses?; (5) How much do you think you will have learned after completing the program?

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • L.J. Boëthius stiftelse
  • Stiftelsen Frimurarna Barnhuset
  • Stiftelsen Promobilia
  • Stiftelsen Sunnerdahls Handikappfond
  • Stiftelsen Sven Jerrings fond
  • Stockholm County Council ALF/PPG

Registry information

Official study title

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

Acronym: SCOPERCT

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Sep 11, 2018
Registry last updated
Dec 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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