The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Group-based education
Waiting list
Standard treatment
Sponsored by
About this trial
This is an interventional other trial for Attention Deficit Disorder With Hyperactivity focused on measuring Behavior therapy, Peer groups, Patient satisfaction, Feasibility studies
Eligibility Criteria
Inclusion Criteria:
- Confirmed ADHD-diagnosis
- speaking a Scandinavian language
Exclusion Criteria:
- Unable to give informed consent
- Psychosis
- Severe learning difficulties
Sites / Locations
- Tiller DPS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Educational intervention
Waiting list
Arm Description
Patients randomized to the intervention group will start with a group-based educational program immediately after the randomization.
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.
Outcomes
Primary Outcome Measures
Change in client Satisfaction
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.
change in patient activation
Patient activation will be measured with the Norwegian version of the Patient Activation Measure Mental Health (PAM-MH) (Green et al 2010))
Secondary Outcome Measures
change in general self-efficacy
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)
change in ADHD-related symptoms
Hopkin's Symptom Checklist (SCL), 9-items scale with high scores on SCL-9 indicating ADHD-related symptom burden (Eich et al 2011)
change in ADHD-related symptoms
Norwegian version of the WHO Adult ADHD Self-report scale, ASRS Short Form (Kessler et al 2005)
change in Quality of Life
Adult Attention Deficit/Hyperactivity Disorder Quality of Life Scale, AAQoL short Form (Brod et al 2006)
Full Information
NCT ID
NCT03547843
First Posted
April 25, 2018
Last Updated
January 25, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03547843
Brief Title
The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity Disorder
Acronym
ADHD
Official Title
The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Behavior therapy, Peer groups, Patient satisfaction, Feasibility studies
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Pilot randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational intervention
Arm Type
Experimental
Arm Description
Patients randomized to the intervention group will start with a group-based educational program immediately after the randomization.
Arm Title
Waiting list
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group-based education
Other Intervention Name(s)
Patient education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Waiting list
Intervention Description
No educational intervention for the duration of the 10 weeks. During this period participants can receive standard treatment.
Intervention Type
Other
Intervention Name(s)
Standard treatment
Other Intervention Name(s)
Treatment as usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in client Satisfaction
Description
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.
Time Frame
from baseline to 2-weeks follow-up
Title
change in patient activation
Description
Patient activation will be measured with the Norwegian version of the Patient Activation Measure Mental Health (PAM-MH) (Green et al 2010))
Time Frame
from baseline to 10-weeks follow-up
Secondary Outcome Measure Information:
Title
change in general self-efficacy
Description
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)
Time Frame
from baseline to 10 weeks follow-up
Title
change in ADHD-related symptoms
Description
Hopkin's Symptom Checklist (SCL), 9-items scale with high scores on SCL-9 indicating ADHD-related symptom burden (Eich et al 2011)
Time Frame
from baseline to 10 weeks follow-up
Title
change in ADHD-related symptoms
Description
Norwegian version of the WHO Adult ADHD Self-report scale, ASRS Short Form (Kessler et al 2005)
Time Frame
from baseline to 10 weeks follow-up
Title
change in Quality of Life
Description
Adult Attention Deficit/Hyperactivity Disorder Quality of Life Scale, AAQoL short Form (Brod et al 2006)
Time Frame
from baseline to 10 weeks follow-up
Other Pre-specified Outcome Measures:
Title
Use of health services and work participation
Description
Self-reported work participation and received services: 3 questions about both work status and received treatment
Time Frame
through study completion, an average of 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed ADHD-diagnosis
speaking a Scandinavian language
Exclusion Criteria:
Unable to give informed consent
Psychosis
Severe learning difficulties
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Lise Løvaas, md phd
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tiller DPS
City
Trondheim
ZIP/Postal Code
7055
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity Disorder
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