Evaluating the Efficacy and Effectiveness of SCOPE - RCT
NCT ID: NCT03665363
Last Updated: 2021-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
144 participants
INTERVENTIONAL
2016-09-01
2021-12-09
Brief Summary
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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 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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SCOPE
Participants allocated to SCOPE, will receive an internet-based psychoeducation intervention, eight weeks of ASD-theme modules with coaching.
SCOPE
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
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.
Self-study
Active control consisting of directed self-studies on internet.
Wait-list controls/Treatment as usual
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.
No interventions assigned to this group
Interventions
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SCOPE
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
Active control consisting of directed self-studies on internet.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
16 Years
25 Years
ALL
Yes
Sponsors
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Stiftelsen Promobilia
UNKNOWN
Stiftelsen Sunnerdahls Handikappfond
OTHER
Stiftelsen Sven Jerrings fond
UNKNOWN
L.J. Boëthius stiftelse
UNKNOWN
Stiftelsen Frimurarna Barnhuset
UNKNOWN
Stockholm County Council ALF/PPG
UNKNOWN
Karolinska Institutet
OTHER
Responsible Party
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Tatja Hirvikoski
Associate Professor
Principal Investigators
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Tatja Hirvikoski, Associate Professor
Role: PRINCIPAL_INVESTIGATOR
Karolinska Insitutet
Locations
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Habilitering & Hälsa
Stockholm, Stockholm County, Sweden
Countries
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References
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Backman A, Roll-Pettersson L, Mellblom A, Norman-Claesson E, Sundqvist E, Zander E, Vigerland S, Hirvikoski T. Internet-Delivered Psychoeducation (SCOPE) for Transition-Aged Autistic Youth: Pragmatic Randomized Controlled Trial. J Med Internet Res. 2024 Nov 28;26:e49305. doi: 10.2196/49305.
Other Identifiers
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SCOPERCT
Identifier Type: -
Identifier Source: org_study_id