Clinical trial NCT03665363: Evaluating the Efficacy and Effectiveness of SCOPE - RCT
Official title: Efficacy and Effectiveness of SCOPE for Intellectually Able Youths With Autism Spectrum Disorder- a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Transition
Keywords: Young adults
Psychoeducation
Internet-based intervention
Adolescents
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stiftelsen Promobilia
name: Stiftelsen Sunnerdahls Handikappfond
name: Stiftelsen Sven Jerrings fond
name: L.J. Boëthius stiftelse
name: Stiftelsen Frimurarna Barnhuset
name: Stockholm County Council ALF/PPG
First posted: 2018-09-11
Enrollment: 144
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in scores on the ASD Knowledge Quiz
timeFrame: Change in knowledge measured at baseline, immediately after the intervention and at three month follow-up
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: Measured at baseline, immediately after the intervention and at three month follow-up
measure: Acceptance and Action Questionnaire (AAQ-II)
timeFrame: Measured at baseline, immediately after the intervention and at three month follow-up
measure: Brunnsviken Brief Quality of Life Inventory (BBQ)
timeFrame: Measured at baseline, immediately after the intervention and at three month follow-up
Other outcomes:
measure: The Treatment Credibility Scale (TCS)
timeFrame: Measured at baseline, immediately after the intervention and at three month follow-up
Locations:
city: Stockholm
country: Sweden
facility: Habilitering & Hälsa
state: Stockholm County
Study officials:
affiliation: Karolinska Insitutet
name: Tatja Hirvikoski, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References: