ADHD: The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity Disorder

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT03547843

Collaborator

St. Olavs Hospital (Other)

Enrollment

Location

Arms

21.5

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity	Behavioral: Group-based education Behavioral: Waiting list Other: Standard treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Pilot randomized clinical trialPilot randomized clinical trial

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder

Actual Study Start Date :

May 31, 2018

Actual Primary Completion Date :

Mar 15, 2020

Actual Study Completion Date :

Mar 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Educational intervention Patients randomized to the intervention group will start with a group-based educational program immediately after the randomization.	Behavioral: Group-based education 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: Patient education Other: Standard treatment 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: Treatment as usual
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.	Behavioral: Waiting list No educational intervention for the duration of the 10 weeks. During this period participants can receive standard treatment. Other: Standard treatment 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: Treatment as usual

Arm

Intervention/Treatment

Experimental: Educational intervention

Patients randomized to the intervention group will start with a group-based educational program immediately after the randomization.

Behavioral: Group-based education

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:

Patient education

Other: Standard treatment

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:

Treatment as usual

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.

Behavioral: Waiting list

No educational intervention for the duration of the 10 weeks. During this period participants can receive standard treatment.

Other: Standard treatment

Other Names:

Treatment as usual

Outcome Measures

Primary Outcome Measures

Change in client Satisfaction [from baseline to 2-weeks follow-up]
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 [from baseline to 10-weeks follow-up]
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 [from baseline to 10 weeks follow-up]
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 [from baseline to 10 weeks follow-up]
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 [from baseline to 10 weeks follow-up]
Norwegian version of the WHO Adult ADHD Self-report scale, ASRS Short Form (Kessler et al 2005)
change in Quality of Life [from baseline to 10 weeks follow-up]
Adult Attention Deficit/Hyperactivity Disorder Quality of Life Scale, AAQoL short Form (Brod et al 2006)

Other Outcome Measures

Use of health services and work participation [through study completion, an average of 24 weeks]
Self-reported work participation and received services: 3 questions about both work status and received treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 67 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmed ADHD-diagnosis
speaking a Scandinavian language

Exclusion Criteria:

Unable to give informed consent
Psychosis
Severe learning difficulties

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tiller DPS	Trondheim		Norway	7055

Sponsors and Collaborators

Norwegian University of Science and Technology
St. Olavs Hospital

Investigators

Study Director: Anne-Lise Løvaas, md phd, St. Olavs Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Norwegian University of Science and Technology

ClinicalTrials.gov Identifier:

NCT03547843

Other Study ID Numbers:

2017/2405 REK

First Posted:

Jun 6, 2018

Last Update Posted:

Jan 27, 2022

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Norwegian University of Science and Technology

Additional relevant MeSH terms:

Hyperkinesis

Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Jan 27, 2022