Evaluating the Efficacy and Effectiveness of SCOPE - RCT

NCT03665363 | Completed

• 1 other identifier: SCOPERCT
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Transition

Keywords

Young adults; Psychoeducation; Internet-based intervention; Adolescents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hospital Anxiety and Depression Scale

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

• Acceptance and Action Questionnaire (AAQ-II)

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

• Brunnsviken Brief Quality of Life Inventory (BBQ)

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

Other Outcomes (1)

• The Treatment Credibility Scale (TCS)

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

Study Arms (3)

SCOPE

EXPERIMENTAL

Participants allocated to SCOPE, will receive an internet-based psychoeducation intervention, eight weeks of ASD-theme modules with coaching.

Other: SCOPE

Self-study

ACTIVE COMPARATOR

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

Wait-list controls/Treatment as usual

NO INTERVENTION

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.

Interventions

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.

SCOPE

Self-study OTHER

Active control consisting of directed self-studies on internet.

Self-study

Eligibility Criteria

• Age: 16 Years - 25 Years
• Gender Eligibility Details: Both biological sex or self-described gender identity will be registered.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Habilitering & Hälsa

Stockholm, Stockholm County, Sweden

Location

Related Publications (1)

• 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.

  PMID: 39608000 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Tatja Hirvikoski, Associate Professor

  Karolinska Insitutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 11, 2018
• Study Start: September 1, 2016
• Primary Completion: August 31, 2021
• Study Completion: December 9, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-12

Locations

SE (1)