Psychoeducational Groups for Adults With ADHD

July 14, 2020 updated by: Norwegian University of Science and Technology

Psychoeducational Groups for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder (ADHD): a Randomized Waitlist-controlled Multicenter Pilot Trial

This pilot study aims to assess patient satisfaction and preliminary efficacy of a psychoeducational group treatment, using a randomized waitlist-controlled trial, at two different outpatient clinics in mid-Norway. All participants will receive standard treatment during the intervention period. Assessment of client satisfaction (CSQ 8), general self-efficacy (GSE-6), ADHD-related quality of life (AAQoL) symptoms of ADHD (SCL-9; ASRS), and work participation will be conducted at time of recruitment prior to randomization (T0), pre- (T1), post-treatment (T2), with a 10 week follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • N-T
      • Levanger, N-T, Norway
        • Levanger Hospital, Nord-Trøndelag Hospital Trust
    • S-T
      • Trondheim, S-T, Norway, 7040
        • Tiller DPS - St. Olavs University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • confirmed ADHD diagnosis
  • speaking a Scandinavian language

Exclusion Criteria:

  • not able or willing to give informed consent
  • psychosis
  • severe learning difficulties

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: psychoeducational groups
Psychoeducational group therapy and standard treatment (ADHD treatment as usual)
Behavioral: Psychoeducational group therapy
The group-based psychoeducational program consists of 10 sessions, run over 10 consecutive weeks. Each session consist of a lecture, given by a recruited expert on the topic of the session (20 minutes) with a following discussion of the topic (45 minutes), facilitated by the course leader. All sessions are organized and led by the course leader, which also includes keeping structure in time, discussion and closing of the session. Psychoeducation comes in addition to standard treatment (ADHD treatment as usual).
Other: Standard treatment
Standard treatment consists of diagnostic assessment of ADHD and comorbidity, as well as treatment with medication. In addition, some patients receive cognitive behavioral therapy, although this is 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
Waiting list and standard treatment (ADHD treatment as usual)
Other: Standard treatment
Standard treatment consists of diagnostic assessment of ADHD and comorbidity, as well as treatment with medication. In addition, some patients receive cognitive behavioral therapy, although this is 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
Behavioral: Waiting list
Waiting list and standard treatment (ADHD treatment as usual)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient satisfaction
Time Frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Measured with a modified version of the Client Satisfaction Questionnaire (CSQ-8). The scale consists of 8 items measured on a scale from 1 to 4. A sum score between 8 and 32 indicate the level of satisfaction with services provided.
Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Change in general self-efficacy
Time Frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Measured with General Self-Efficacy Scale (GSE-6), a short-form measure of self-efficacy. Self-efficacy is regarded as a protective factor in adapting to stress and chronic illness. The scale consists of 6 items, measured on a 4-point scale, with a possible range of 6-24.
Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ADHD-related symptoms (ASRS)
Time Frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Measured with ASRS, a self-reporting scale for ADHD-related symptoms in adults. The scale consists of 18 items, based on DSM-V diagnostic criteria for ADHD. The items are measured on a 5-point scale, with a possible range of 0-72.
Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Change in ADHD-related symptoms (SCL-9)
Time Frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Measured with 9 items from the SCL-90. SCL-9 is an ADHD-specific scale, consisting of 9 items of the original 90. SCL-9 covers the specific characteristic traits of ADHD.
Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Change in ADHD-related quality of life
Time Frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Measured with AAQoL - which covers ADHD-specific quality of life and function. AAQoL consists of 29 questions measuring health related quality of life among adults with ADHD.
Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

Helse Nord-Trøndelag HF

Investigators

  • Principal Investigator: Terje Torgersen, phd, St. Olavs Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2017

Primary Completion (Actual)

June 15, 2019

Study Completion (Actual)

June 15, 2019

Study Registration Dates

First Submitted

November 2, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (Actual)

November 9, 2017

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/1885

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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