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Evaluating the Efficacy and Effectiveness of SCOPE - RCT (SCOPERCT)

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ClinicalTrials.gov Identifier: NCT03665363
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborators:
Stiftelsen Promobilia
Stiftelsen Sunnerdahls Handikappfond
Stiftelsen Sven Jerrings fond
L.J. Boëthius stiftelse
Stiftelsen Frimurarna Barnhuset
Stockholm County Council ALF/PPG
Information provided by (Responsible Party):
Tatja Hirvikoski, Karolinska Institutet

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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Transition Other: SCOPE Other: Self-study Not Applicable

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-lsit 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 assessment covers depression symptoms and suicidality using MADRS-R, functional impairment using WHODAS 2.0 (WHO), 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 gained knowledge about ASD. Secondary outcomes are mental health: anxiety and depression, and also acceptance of diagnosis as well as quality of life. In addition, measures of treatment credibility are also completed by the coaches. The measures will be analysed using a series of mixed design repeated measures ANOVAs (rmANOVAs).

The recommended first-line intervention for ASD is psychoeducation. Psychoeducational interventions for young adult individuals with ASD however 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 will carry on through until 2020 or until sufficient participant numbers have been met.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Efficacy and Effectiveness of SCOPE for Intellectually Able Youths With Autism Spectrum Disorder- a Randomized Controlled Study
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SCOPE
Participants allocated to SCOPE, will receive an internet-based psychoeducation intervention, eight weeks of ASD-theme modules with coaching.
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.

Active Comparator: 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.
Other: Self-study
Active control consisting of directed self-studies on internet.

No Intervention: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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?



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Both biological sex or self-described gender identity will be registered.
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665363


Contacts
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Contact: Tatja Hirvikoski, Associate Professor tatja.hirvikoski@ki.se
Contact: Anna N Backman, MSc anna.backman@ki.se

Locations
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Sweden
Habilitering & Hälsa Recruiting
Stockholm, Stockholm County, Sweden
Contact: Anna N Backman, MSc       anna.backman@ki.se   
Sponsors and Collaborators
Karolinska Institutet
Stiftelsen Promobilia
Stiftelsen Sunnerdahls Handikappfond
Stiftelsen Sven Jerrings fond
L.J. Boëthius stiftelse
Stiftelsen Frimurarna Barnhuset
Stockholm County Council ALF/PPG
Investigators
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Principal Investigator: Tatja Hirvikoski, Associate Professor Karolinska Insitutet

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Responsible Party: Tatja Hirvikoski, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03665363     History of Changes
Other Study ID Numbers: SCOPERCT
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tatja Hirvikoski, Karolinska Institutet:
Young adults
Psychoeducation
Internet-based intervention
Adolescents

Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders