- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03547843
The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder
Peer co-led education describes educators who are expert patients, user representatives or former patients, participating and teaching in educational interventions in cooperation with health care professionals. Peer co-led education is included in the Norwegian national guidelines for treatment of mental disorders, but despite some promising results for the treatment of other conditions, still little is known about the efficacy of peer co-led educational group interventions interventions for adults with attention deficit and hyperactivity disorder (ADHD).
This pilot trial will evaluate patient satisfaction with and preliminary efficacy of a 2-session peer co-led educational group program designed to address specific challenges faced by adults diagnosed with ADHD at an outpatient clinics in mid-Norway.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Trondheim, Norway, 7055
- Tiller DPS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Confirmed ADHD-diagnosis
- speaking a Scandinavian language
Exclusion Criteria:
- Unable to give informed consent
- Psychosis
- Severe learning difficulties
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Educational intervention
Patients randomized to the intervention group will start with a group-based educational program immediately after the randomization.
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The group-based educational program consists of two sessions that run over two consecutive weeks.
Each session consists of a lecture from a recruited expert on the topic of the session and by expert patients with a following discussion of the topic facilitated by the course leader.
Other Names:
Diagnostic treatment with medication.
In addition, some patients receive cognitive behavioral therapy (not systematically given to every patient).
If needed, patients are also offered assistance with regard to economy, housing, education, and work as well as contact with family and network.
Other Names:
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Active Comparator: Waiting list
Participants randomized to the waiting list control group receive no educational intervention for the duration of the 10 weeks.
During this period participants can receive standard treatment, consisting of diagnostic treatment with medication.
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Diagnostic treatment with medication.
In addition, some patients receive cognitive behavioral therapy (not systematically given to every patient).
If needed, patients are also offered assistance with regard to economy, housing, education, and work as well as contact with family and network.
Other Names:
No educational intervention for the duration of the 10 weeks.
During this period participants can receive standard treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in client Satisfaction
Time Frame: from baseline to 2-weeks follow-up
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Client satisfaction will be measured with Client Satisfaction Questionnaire, short form (Attkisson & Zwick, 1982).
The scale consists of 8 items scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction).
Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
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from baseline to 2-weeks follow-up
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change in patient activation
Time Frame: from baseline to 10-weeks follow-up
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Patient activation will be measured with the Norwegian version of the Patient Activation Measure Mental Health (PAM-MH) (Green et al 2010))
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from baseline to 10-weeks follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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change in general self-efficacy
Time Frame: from baseline to 10 weeks follow-up
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General Self-Efficacy Scale, 6-item scale ranging from 1 ('not at all true') to 4 ('exactly true').
Total scores range from 6 to 24, with higher scores indicating greater self-efficacy.
(Romppel et al 2013)
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from baseline to 10 weeks follow-up
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change in ADHD-related symptoms
Time Frame: from baseline to 10 weeks follow-up
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Hopkin's Symptom Checklist (SCL), 9-items scale with high scores on SCL-9 indicating ADHD-related symptom burden (Eich et al 2011)
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from baseline to 10 weeks follow-up
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change in ADHD-related symptoms
Time Frame: from baseline to 10 weeks follow-up
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Norwegian version of the WHO Adult ADHD Self-report scale, ASRS Short Form (Kessler et al 2005)
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from baseline to 10 weeks follow-up
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change in Quality of Life
Time Frame: from baseline to 10 weeks follow-up
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Adult Attention Deficit/Hyperactivity Disorder Quality of Life Scale, AAQoL short Form (Brod et al 2006)
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from baseline to 10 weeks follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Use of health services and work participation
Time Frame: through study completion, an average of 24 weeks
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Self-reported work participation and received services: 3 questions about both work status and received treatment
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through study completion, an average of 24 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Anne-Lise Løvaas, md phd, St. Olavs hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/2405 REK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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