NCT05726812

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

December 9, 2022

Last Update Submit

July 16, 2024

Conditions

Keywords

Planning and organization skillsPlan My LifeGroup Training

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (3)

  • Change in AVL - parent rated (see description)

    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)

    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)

    Baseline (start study) - T0 (=9 weeks after start study, intervention starts) - T1 (=18 weeks after start study) - T2 (=27 weeks after start study)

Other Outcomes (1)

  • Scale questions on satisfaction

    Only at T2 (=27 weeks after start study)

Interventions

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.

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GGZ Noord-Holland-Noord

Heerhugowaard, 1703WC, Netherlands

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Manon van Hensbergen, MSc

    GGZ Noord-Holland-Noord

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2022

First Posted

February 14, 2023

Study Start

March 1, 2023

Primary Completion

July 15, 2024

Study Completion

July 15, 2024

Last Updated

July 17, 2024

Record last verified: 2024-07

Locations