- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05726812
Plan My Life Together; a Group Training for Adolescents With ADHD
A Group Training to Plan and Organize for Adolescents With ADHD: Effectiveness and Feasibility
This observational study is a first orientation on the effects and feasibility of a group training to plan and organize for adolescents with attention deficit disorder (ADHD). This study focuses on the following questions:
- Is there an improvement on planning skills after training?
- Are there fewer ADHD characteristics after training?
- Is there an improvement on self-esteem after training?
- How feasible is a group training for adolescents with ADHD?
- How satisfied are practitioners and adolescents about the training?
Based on the effect-size of the individual training variant, the literature on the effect of group treatment and the adolescent target group, in which the peer group gets more important, the hypothesis is that the group training Plan My Life Together will have a medium to large effect on planning skills. Furthermore, positive effects on ADHD characteristics and self-esteem are also expected. The assumption is that Plan My Life Together is feasible and suitable.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Attention deficit and/or hyperactivity and impulsivity disorder (ADHD) has a high prevalence in the adolescence. In this age stage, where independence and personal responsibility become increasingly important, ADHD is characterized mainly by problems in executive functions and there are often problems in planning schoolwork.This is frequently accompanied by tensions in the family. More co-morbidity also develops, including problems in self-image, as a result of negative feedback from the environment. Individual behavioral treatment has been found to be effective in reducing ADHD symptoms. In the ADHD guidelines (cognitive) behavioral therapy aimed at planning and organization, with consideration for motivational interviewing elements, is recommended for adolescents.
In the individual training Plan My Life, adolescents learn to plan their school and homework better through cognitive behavioral therapy (CBT) and motivational interviewing, so that they have fewer problems with their ADHD characteristics and have more positive experiences. The training is proven effective, few adolescents drop out, and parents and practitioners are positive about the training. The training was developed and studied on an individual basis.
There may be advantages to offering this training in a group setting. Among other things, the group can serve as a catalyst and experiences can be shared. Group therapy has been shown to work for several mental disorders, in some cases even better than the individual therapy. It is obvious that in adolescence the group is relatively even more important. Also, group treatment can be more efficient.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Eva Velthorst, PhD
- Phone Number: + 31 6 18644345
- Email: e.velthorst@ggz-nhn.nl
Study Contact Backup
- Name: Rosa van Mourik, PhD
- Phone Number: +31 613097498
- Email: r.vanmourik@ggz-nhn.nl
Study Locations
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Heerhugowaard, Netherlands, 1703WC
- Recruiting
- GGZ Noord-Holland-Noord
-
Contact:
- Manon van Hensbergen, MSc
- Phone Number: +31 6 20853373
- Email: m.vanhensbergen@ggz-nhn.nl
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- adolescents with an ADHD classification according to the DSM-5.
- age 12 to 16 years.
- outpatient treatment at "GGZ-NHN" (specialized mental health care service in the Netherlands))
- currently following secondary regular education
- Intention to participate in the group and willingness to fill out questionnaires several times.
Exclusion Criteria:
- a DSM-5 classification of autism
- acute crisis situation (acute suicidality, acute psychotic symptoms, addiction problems requiring immediate treatment, or unsafe home situation)
- Insufficient mastery of the Dutch language.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the subscale scores plan/organize - self rated (from BRIEF-2, see description))
Time Frame: Baseline (start study) - T0 (=9 weeks after start study, intervention starts) - T1 (=18 weeks after start study) - T2 (=27 weeks after start study)
|
Subscale plan/organize from the Behavior Rating Inventory of Executive Function - Adolescent version Higher scores indicated better planning/organizing scales. Subscale ranges from 8 - 24 |
Baseline (start study) - T0 (=9 weeks after start study, intervention starts) - T1 (=18 weeks after start study) - T2 (=27 weeks after start study)
|
Change in the subscale score plan/organize - parent rated (from BRIEF-2, see description)
Time Frame: Baseline (start study) - T0 (=9 weeks after start study, intervention starts) - T1 (=18 weeks after start study) - T2 (=27 weeks after start study)
|
Subscale plan/organize from the Behavior Rating Inventory of Executive Function - Parent version Higher scores indicated better planning/organizing scales. Subscale ranges from 8 - 24 |
Baseline (start study) - T0 (=9 weeks after start study, intervention starts) - T1 (=18 weeks after start study) - T2 (=27 weeks after start study)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in AVL - parent rated (see description)
Time Frame: Baseline (start study) - T0 (=9 weeks after start study, intervention starts) - T1 (=18 weeks after start study) - T2 (=27 weeks after start study)
|
ADHD Vragenlijst - ouders (ADHD rating scale, Dutch version) Higher scores indicate more ADHD-symptoms. Range: 0 - 72 |
Baseline (start study) - T0 (=9 weeks after start study, intervention starts) - T1 (=18 weeks after start study) - T2 (=27 weeks after start study)
|
Change in RSES - self rated (see description)
Time Frame: Baseline (start study) - T0 (=9 weeks after start study, intervention starts) - T1 (=18 weeks after start study) - T2 (=27 weeks after start study)
|
Rosenberg Self Esteem Scale - Adolescent version Higher scores indicate more self-esteem. Range: 0-40 |
Baseline (start study) - T0 (=9 weeks after start study, intervention starts) - T1 (=18 weeks after start study) - T2 (=27 weeks after start study)
|
Change in RSES - parent rated (see description)
Time Frame: Baseline (start study) - T0 (=9 weeks after start study, intervention starts) - T1 (=18 weeks after start study) - T2 (=27 weeks after start study)
|
Rosenberg Self Esteem Scale - Parent version Higher scores indicate more self-esteem. Range: 0-40 |
Baseline (start study) - T0 (=9 weeks after start study, intervention starts) - T1 (=18 weeks after start study) - T2 (=27 weeks after start study)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scale questions on satisfaction
Time Frame: Only at T2 (=27 weeks after start study)
|
Scale questions for practitioners and adolescents to measure satisfaction with the group training Higher scores indicate more satisfaction. Range: 1-10. |
Only at T2 (=27 weeks after start study)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Manon van Hensbergen, MSc, GGZ Noord-Holland-Noord
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GGZNHN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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