NCT03547843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

May 31, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

January 27, 2022

Status Verified

August 1, 2021

Enrollment Period

1.8 years

First QC Date

April 25, 2018

Last Update Submit

January 25, 2022

Conditions

Keywords

Behavior therapyPeer groupsPatient satisfactionFeasibility studies

Outcome Measures

Primary Outcomes (2)

  • 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.

    from baseline to 2-weeks follow-up

  • 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))

    from baseline to 10-weeks follow-up

Secondary Outcomes (4)

  • change in general self-efficacy

    from baseline to 10 weeks follow-up

  • change in ADHD-related symptoms

    from baseline to 10 weeks follow-up

  • change in ADHD-related symptoms

    from baseline to 10 weeks follow-up

  • change in Quality of Life

    from baseline to 10 weeks follow-up

Other Outcomes (1)

  • Use of health services and work participation

    through study completion, an average of 24 weeks

Study Arms (2)

Educational intervention

EXPERIMENTAL

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

Behavioral: Group-based educationOther: Standard treatment

Waiting list

ACTIVE COMPARATOR

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 listOther: Standard treatment

Interventions

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.

Also known as: Patient education
Educational intervention
Waiting listBEHAVIORAL

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

Waiting list

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.

Also known as: Treatment as usual
Educational interventionWaiting list

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed ADHD-diagnosis
  • speaking a Scandinavian language

You may not qualify if:

  • Unable to give informed consent
  • Psychosis
  • Severe learning difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tiller DPS

Trondheim, 7055, Norway

Location

Related Publications (1)

  • Skliarova T, Grawe RW, Vaag J, Mandahl A, Kolltveit I, Lovas I, Torgersen T, Lara-Cabrera ML. Pilot randomised controlled trial on the feasibility and intervention satisfaction with an educational group programme for adults with attention deficit hyperactivity disorder and their caregivers. BMC Psychiatry. 2025 Feb 20;25(1):161. doi: 10.1186/s12888-025-06570-4.

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityPatient Satisfaction

Interventions

Patient Education as TopicWaiting ListsTherapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesAppointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Anne-Lise Løvaas, md phd

    St. Olavs Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Pilot randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2018

First Posted

June 6, 2018

Study Start

May 31, 2018

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

January 27, 2022

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations