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

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ClinicalTrials.gov Identifier: NCT03547843
Recruitment Status : Not yet recruiting
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Pilot 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
Estimated Study Start Date : June 10, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Treatment as usual




Primary Outcome Measures :
  1. Change in client Satisfaction [ Time Frame: 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.

  2. change in patient activation [ Time Frame: 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 :
  1. change in general self-efficacy [ Time Frame: 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)

  2. change in ADHD-related symptoms [ Time Frame: 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)

  3. change in ADHD-related symptoms [ Time Frame: from baseline to 10 weeks follow-up ]
    Norwegian version of the WHO Adult ADHD Self-report scale, ASRS Short Form (Kessler et al 2005)

  4. change in Quality of Life [ Time Frame: 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:
  1. Use of health services and work participation [ Time Frame: through study completion, an average of 24 weeks ]
    Self-reported work participation and received services: 3 questions about both work status and received treatment



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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed ADHD-diagnosis
  • speaking a Scandinavian language

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547843


Contacts
Contact: Mariela L. Lara-Cabrera, PhD 004748280188 mariela.lara@ntnu.no
Contact: Terje Torgersen, PhD 004793419909 terje.torgersen@ntnu.no

Locations
Norway
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

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03547843     History of Changes
Other Study ID Numbers: 2017/2405 REK
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Behavior therapy
Peer groups
Patient satisfaction
Feasibility studies

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms