Evaluating the Efficacy and Effectiveness of SCOPE - RCT

Autism Spectrum Disorder Clinical Trial

— SCOPERCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665363
• Other study ID #: SCOPERCT
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: December 9, 2021

Study information

• Verified date: December 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 9, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Transition

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Sweden	Habilitering & Hälsa	Stockholm	Stockholm County

Sponsors (7)

Lead Sponsor	Collaborator
Karolinska Institutet	L.J. Boëthius stiftelse, Stiftelsen Frimurarna Barnhuset, Stiftelsen Promobilia, Stiftelsen Sunnerdahls Handikappfond, Stiftelsen Sven Jerrings fond, Stockholm County Council ALF/PPG

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Treatment Credibility Scale (TCS)	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?	Measured at baseline, immediately after the intervention and at three month follow-up
Primary	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	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
Secondary	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
Secondary	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