Organizational Skills Training for Children With ADHD (OST)

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.

Study Overview

• Status: Recruiting
• Conditions: ADHD
• Intervention / Treatment: Behavioral: Organizational skills training; Other: Treatment as usual

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 Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aida Bikic, Ph.D.; Phone Number: +45 29168216; Email: aida.bikic@rsyd.dk
• Study Contact Backup: Name: Søren Dalsgaard, MD, Ph.D.; Phone Number: sdalsgaard@econ.au.dk

Study Locations

• Denmark
  • Aabenraa, Denmark, 6200
    • Recruiting
    • Department of Child and Adolescent Mental Health Services
  • Vejle, Denmark
    • Recruiting
    • Department of Child and Adolescent Mental Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; The participants in the intervention group will receive treatment as usual + 10 sessions of organizational skills training	Behavioral: Organizational skills training; 10 sessions of parent and child training in a group format.; Other: Treatment as usual; Treatment as usual in the outpatient clinic
OTHER: Control; Control participants will receive treatment as usual.	Other: Treatment as usual; Treatment as usual in the outpatient clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children Organizational Skills Scale (COSS)-parent	organizational skills questionnaire	after 10 weeks of intervention

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior Rating Inventory of Executive Functions (BRIEF)-teacher	executive functions questionnaire	after 10 weeks of intervention
CANTAB Stop Signal Task (SST)	cognitive test	after 10 weeks of intervention
CANTAB one touch Stockings of Cambridge (SOC)	cognitive test	after 10 weeks of intervention
CANTAB Working Memory (WM)	cognitive test	after 10 weeks of intervention
Non-serious adverse events	adverse events	after 10 weeks of intervention
Serious adverse events	adverse events	after 10 weeks of intervention
Children Organizational Skills Scale (COSS)-parent	organizational skills questionnaire	24 weeks after ended intervention
Children Organizational Skills Scale (COSS)-teacher	organizational skills questionnaire	24 weeks after ended intervention
ADHD-Rating Scale (ADHD-RS) (parent edition)	ADHD symptoms questionnaire	24 weeks after ended intervention
ADHD-Rating Scale (ADHD-RS) (teacher edition)	ADHD symptoms questionnaire	24 weeks after ended intervention
Behavior Rating Inventory of Executive Functions (BRIEF)-parent	executive functions questionnaire	24 weeks after ended intervention
Behavior Rating Inventory of Executive Functions (BRIEF)-teacher	executive functions questionnaire	24 weeks after ended intervention
CANTAB Stop Signal Task (SST)	cognitive test	24 weeks after ended intervention
CANTAB one touch Stockings of Cambridge (SOC)	cognitive test	24 weeks after ended intervention
CANTAB Rapid Visual Movement (RVP)	cognitive test	24 weeks after ended intervention
CANTAB Working Memory (WM)	cognitive test	24 weeks after ended intervention
Weis's scale of disability-Parent Report (WFIRS-P)	functional outcome questionnaire	24 weeks after ended intervention
Non-serious adverse events	adverse events	24 weeks after ended intervention
Serious adverse events	adverse events	24 weeks after ended intervention
CANTAB Reaction time task (RTI)	reaction time	after 10 weeks of intervention
CANTAB Reaction time task (RTI)	reaction time	after 24 weeks of intervention
ADHD-Rating Scale (ADHD-RS) (teacher edition)	ADHD symptoms questionnaire	after 10 weeks of intervention

Collaborators and Investigators

• Sponsor: Region Syddanmark
• Investigators: Principal Investigator: Aida Bikic, Ph.D., Region of Southern Denmark and University of Southern Denmark

Publications and helpful links

General Publications

• Bikic A, Dalsgaard S, Olsen KD, Sukhodolsky DG. Organizational skills training for children with ADHD: study protocol for a randomized, controlled trial. Trials. 2021 Oct 29;22(1):752. doi: 10.1186/s13063-021-05499-9.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2017
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (ACTUAL): May 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 55772 S-20160180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: After the competition of the study, data will be stored in Danish National Archives, where data can be accessed after previous approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No