ADHDNCT05726812
Plan My Life Together; a Group Training for Adolescents With ADHD
An observational study of ADHD and Adolescence, run by GGZ Noord-Holland-Noord at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- ADHD, Adolescence
- What is being tested?
- Plan My Life Together
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2023to 15 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants are from the region "North-Holland" and receive mental health care for ADHD and possible other mental health problems. Medication use is allowed if participants function stable on medication.
Who may be able to join
- 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)) or at "Psychologenpraktijk Kuin" (first-line psychological mental health care, Haarlem)
- currently following secondary regular education
- Intention to participate in the group and willingness to fill out questionnaires several times.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- ADHD, Adolescence
- Being tested
- Plan My Life Together
- Keywords
- Planning and organization skills, Plan My Life, Group Training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plan My Life TogetherBehavioural
A group training for adolescents with ADHD in which they learn to plan and organize. The training consists of 8 weekly sessions of 90 minutes for the adolescent and 2 parent sessions of 90 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the subscale scores plan/organize - self rated (from BRIEF-2, see description))
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
Measured: 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)
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
Measured: Baseline (start study) - T0 (=9 weeks after start study, intervention starts) - T1 (=18 weeks after start study) - T2 (=27 weeks after start study)
Secondary outcomes (3)
Change in AVL - parent rated (see description)
ADHD Vragenlijst - ouders (ADHD rating scale, Dutch version)
Higher scores indicate more ADHD-symptoms. Range: 0 - 72
Measured: 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)
Rosenberg Self Esteem Scale - Adolescent version
Higher scores indicate more self-esteem. Range: 0-40
Measured: 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)
Rosenberg Self Esteem Scale - Parent version
Higher scores indicate more self-esteem. Range: 0-40
Measured: Baseline (start study) - T0 (=9 weeks after start study, intervention starts) - T1 (=18 weeks after start study) - T2 (=27 weeks after start study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start1 Mar 2023
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GGZ Noord-Holland-Noord
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Leiden
- Responsible party
- Sponsor
- Investigators
- Manon van Hensbergen, MSc, Principal investigator, GGZ Noord-Holland-Noord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726812
- Sponsor's protocol ID
- GGZNHN
- Status last verified
- Jul 2024
- First submitted
- 9 Dec 2022
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonimized data will be shared upon request and careful consideration of research plan by the principal investigators.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Group Training to Plan and Organize for Adolescents With ADHD: Effectiveness and Feasibility
- ClinicalTrials.gov ID
- NCT05726812
- Acronym / sponsor ID
- GGZNHN
- Conditions
- ADHD, Adolescence
- Keywords
- Planning and organization skills, Plan My Life, Group Training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GGZ Noord-Holland-NoordUniversity, hospital or other
- Collaborators
- Universiteit Leiden
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants are from the region "North-Holland" and receive mental health care for ADHD and possible other mental health problems. Medication use is allowed if participants function stable on medication.
Key inclusion criteria (5 listed)
- 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)) or at "Psychologenpraktijk Kuin" (first-line psychological mental health care, Haarlem)
- currently following secondary regular education
- Intention to participate in the group and willingness to fill out questionnaires several times.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plan My Life TogetherA group training for adolescents with ADHD in which they learn to plan and organize. The training consists of 8 weekly sessions of 90 minutes for the adolescent and 2 parent sessions of 90 minutes. | Behavioural | – |
Primary outcome
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
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
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Undecided. Anonimized data will be shared upon request and careful consideration of research plan by the principal investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manon van Hensbergen, MSc principal investigator
GGZ Noord-Holland-Noord
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD and Adolescence, run by GGZ Noord-Holland-Noord at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.