NCT03160378

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 8, 2022

Status Verified

April 1, 2022

Enrollment Period

5.3 years

First QC Date

May 16, 2017

Last Update Submit

April 7, 2022

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

  • Children Organizational Skills Scale (COSS)-parent

    organizational skills questionnaire

    after 10 weeks of intervention

Secondary Outcomes (5)

  • Children Organizational Skills Scale (COSS)-teacher

    after 10 weeks of intervention

  • ADHD-Rating Scale (ADHD-RS) (parent edition)

    after 10 weeks of intervention

  • Behavior Rating Inventory of Executive Functions (BRIEF)-parent

    after 10 weeks of intervention

  • CANTAB Rapid Visual Movement (RVP)

    after 10 weeks of intervention

  • Weis's scale of disability-Parent Report (WFIRS-P)

    after 10 weeks of intervention

Other Outcomes (22)

  • Behavior Rating Inventory of Executive Functions (BRIEF)-teacher

    after 10 weeks of intervention

  • CANTAB Stop Signal Task (SST)

    after 10 weeks of intervention

  • CANTAB one touch Stockings of Cambridge (SOC)

    after 10 weeks of intervention

  • +19 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

The participants in the intervention group will receive treatment as usual + 10 sessions of organizational skills training

Behavioral: Organizational skills trainingOther: Treatment as usual

Control

OTHER

Control participants will receive treatment as usual.

Other: Treatment as usual

Interventions

Organizational skills trainingBEHAVIORAL

10 sessions of parent and child training in a group format.

Intervention
Treatment as usualOTHER

Treatment as usual in the outpatient clinic

ControlIntervention

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ADHD diagnosis after clinical interview K-SADS
  • age between 6-13 years, both inclusive; informed consent.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Child and Adolescent Mental Health Services

Aabenraa, 6200, Denmark

RECRUITING

Department of Child and Adolescent Mental Health Services

Vejle, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34715906DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Aida Bikic, Ph.D.

    Region of Southern Denmark and University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aida Bikic, Ph.D.

CONTACT

+45 29168216aida.bikic@rsyd.dk

Søren Dalsgaard, MD, Ph.D.

CONTACT

sdalsgaard@econ.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D., clinical psychologist

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 19, 2017

Study Start

May 22, 2017

Primary Completion

September 1, 2022

Study Completion

December 1, 2022

Last Updated

April 8, 2022

Record last verified: 2022-04

Locations

DK(2)