Organizational Skills Training for Children With ADHD

Not Applicable

• Conditions: ADHD
• Interventions: Other: Treatment as usual; Behavioral: Organizational skills training

• Registration Number: NCT03160378
• Lead Sponsor: Region Syddanmark

Brief Summary

The purpose of this trial is to investigate the effect of organizational skills training, a parent and child training approach on organizational skills, inattentive symptoms and functional outcome in children age 6-13 years. Half of the participants will receive treatment as usual (TAU) and organizational skills training and the other half will receive TAU.

Detailed Description

Organizational skills training (OST) is a behavioral intervention that has been increasingly used to address difficulties with time management and organization of materials in children with ADHD, that tend to persist despite medication and behavioral treatments. This randomized clinical superiority trial is going to investigate the effect of Organizational Skills Training, a group treatment approach for parents and children. The program is also involving a computerized program, vTime, that will help the children manage time more effectively. A total of 98 children with ADHD aged 6-13 years is expected to be randomized to either intervention or control group in a single blind design. Both groups will receive treatment-as-usual. The intervention group is going to participate in a group training for parents and children for 10 weekly sessions.

Study Timeline

• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-19
• Study Start: 2017-05-22
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-04-08
• Primary Completion: 2022-09-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. ADHD diagnosis after clinical interview K-SADS
2. age between 6-13 years, both inclusive; informed consent.
3. The child has to score at least one standard deviation (SD) above the mean on the Plan/Organize subscale on the Behavior Rating Inventory of Executive Functions (BRIEF) (parent edition) verifying problems with organizational skills.

Exclusion Criteria

1. autism spectrum disorder
2. serious psychopathology requiring immediate clinical attention (e.g., severe depression or aggressive behavior)
3. head injury or verified neurological disease
4. intelligence quotient (IQ <80)
5. medical condition, requiring primary treatment
6. no informed consent from custody.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Treatment as usual	Control participants will receive treatment as usual.
Intervention	Organizational skills training	The participants in the intervention group will receive treatment as usual + 10 sessions of organizational skills training
Intervention	Treatment as usual	The participants in the intervention group will receive treatment as usual + 10 sessions of organizational skills training

Primary Outcome Measures

Name	Time	Method
Children Organizational Skills Scale (COSS)-parent	after 10 weeks of intervention	organizational skills questionnaire

Secondary Outcome Measures

Name	Time	Method
ADHD-Rating Scale (ADHD-RS) (parent edition)	after 10 weeks of intervention	ADHD symptoms questionnaire
Behavior Rating Inventory of Executive Functions (BRIEF)-parent	after 10 weeks of intervention	executive functions questionnaire
Children Organizational Skills Scale (COSS)-teacher	after 10 weeks of intervention	organizational skills questionnaire
CANTAB Rapid Visual Movement (RVP)	after 10 weeks of intervention	cognitive test
Weis's scale of disability-Parent Report (WFIRS-P)	after 10 weeks of intervention	functional outcome questionnaire

Trial Locations

Locations (1)

Department of Child and Adolescent Mental Health Services; 🇩🇰 Vejle, Denmark