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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05726812
Other study ID # GGZNHN
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date December 2024

Study information

Verified date October 2023
Source GGZ Noord-Holland-Noord
Contact Eva Velthorst, PhD
Phone + 31 6 18644345
Email e.velthorst@ggz-nhn.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Plan My Life Together
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.

Locations

Country Name City State
Netherlands GGZ Noord-Holland-Noord Heerhugowaard

Sponsors (2)

Lead Sponsor Collaborator
GGZ Noord-Holland-Noord Universiteit Leiden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Scale questions on satisfaction 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)
Primary 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
Baseline (start study) - T0 (=9 weeks after start study, intervention starts) - T1 (=18 weeks after start study) - T2 (=27 weeks after start study)
Primary 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
Baseline (start study) - T0 (=9 weeks after start study, intervention starts) - T1 (=18 weeks after start study) - T2 (=27 weeks after start study)
Secondary Change in AVL - parent rated (see description) 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)
Secondary Change in RSES - self rated (see description) 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)
Secondary Change in RSES - parent rated (see description) 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)
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