- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02300597
Internet-based Support for Young People With ADHD and Autism - a Controlled Study
May 20, 2019 updated by: Elisabet Wentz, Göteborg University
Internet-based Support and Coaching for Adolescents and Young Adults With ADHD and Autism Spectrum Disorders - a Controlled Study
Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered internet-based support and coaching during eight weeks (chat and e-mail).
Data is collected before and after the intervention and six months after end of treatment using self-report questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive and anxiety symptoms and socioeconomic status.
Parents complete an assessment scale for the next of kin.
After treatment the young people are interviewed regarding the quality of the intervention.
A comparison group matched for age, gender and neuropsychiatric diagnosis is offered treatment as usual and is assessed at the same time points as the intervention group.
The individuals are not randomized due to difficulties to recruit if the individuals do not know group assignment in advance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are consecutively included in the project and are offered coaching and support during eight weeks over the internet (chat and e-mail) twice a week.
Data is collected before and after the intervention as well as six months after end of treatment using self-report questionnaires (Sense of Coherence (SOC), Rosenberg Self Esteem Scale, Manchester Short Assessment of Quality of Life (MANSA), Montgomery Asberg Depression Rating Scale (MADRS), and Hospital Anxiety and Depression Scale (HAD)).
A parent or a partner completes an assessment scale for the next of kin.
When treatment is completed, the young people are interviewed using a structured interview pertaining to the quality of the intervention.
A comparison group matched for age, gender and neuropsychiatric diagnosis is offered treatment as usual (TAU) and is assessed at the same time points as the intervention group.
The individuals are not randomized to the intervention and comparison groups due to difficulties to recruit if the individuals do not know group assignment in advance.
In all, 24 individuals will be offered the intervention and 24 individuals will receive TAU.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gothenburg, Sweden, SE-413 45
- Department of Psychiatry and Neurochemistry, Institute of Neurosceince and Physiology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 30 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ADHD and/or autism spectrum disorder
- Age 15 to 30
Exclusion Criteria:
- No current antisocial behaviour, psychotic symptoms and/or alcohol/substance abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Internet based support and coaching
Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered internet-based support and coaching during eight weeks (chat and e-mail).
Data is collected before and after the intervention and six months after end of treatment using self-report questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive and anxiety symptoms and socioeconomic status.
Parents complete an assessment scale for the next of kin.
After treatment the young people are interviewed regarding the quality of the intervention.
|
Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered internet-based support and coaching during eight weeks (chat and e-mail).
Data is collected before and after the intervention and six months after end of treatment using self-report questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive and anxiety symptoms and socioeconomic status.
Parents complete an assessment scale for the next of kin.
After treatment the young people are interviewed regarding the quality of the intervention.
|
|
NO_INTERVENTION: Treatment as usual (TAU)
A comparison group matched for age, gender and neuropsychiatric diagnosis is offered treatment as usual and is assessed at the same time points as the intervention group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
QoL
Time Frame: T2: immediately after intervention; T3: 6 months after intervention. Outcome Measure is going to report a change.
|
Self report questionnaire; Manchester Short Assesment of Quality of Life (MANSA), Priebe et.
al. 1999.
|
T2: immediately after intervention; T3: 6 months after intervention. Outcome Measure is going to report a change.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self esteem
Time Frame: T2: immediately after intervention; T3: 6 months after intervention
|
Self report questionnaire; Rosenberg Self-Esteem Scale (Rosenberg, 1965, 1989)
|
T2: immediately after intervention; T3: 6 months after intervention
|
|
Sense of coherence
Time Frame: T2: immediately after intervention; T3: 6 months after intervention
|
Self report questionnaire; Sense of Coherence (SOC-29), Antonovsky, 1987.
|
T2: immediately after intervention; T3: 6 months after intervention
|
|
Anxiety and depressive symptoms
Time Frame: T2: immediately after intervention; T3: 6 months after intervention
|
Self report questionnaire; Hospital Anxiety and Depression Scale (HAD), Zigmond & Snaith, 1983.
|
T2: immediately after intervention; T3: 6 months after intervention
|
|
Depressive symptoms
Time Frame: T2: immediately after intervention; T3: 6 months after intervention
|
Self report questionnaire; Montgomery Asberg Depression Rating Scale (MADRS), Montgomery & Asberg, 1979.
|
T2: immediately after intervention; T3: 6 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (ACTUAL)
June 1, 2015
Study Completion (ACTUAL)
June 1, 2015
Study Registration Dates
First Submitted
November 10, 2014
First Submitted That Met QC Criteria
November 24, 2014
First Posted (ESTIMATE)
November 25, 2014
Study Record Updates
Last Update Posted (ACTUAL)
May 21, 2019
Last Update Submitted That Met QC Criteria
May 20, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBSC-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.