NCT05231486

Brief Summary

Developmental Coordination Disorder (DCD) is a neurodevelopmental disorder that causes difficulty in motor coordination both in their learning and in their execution. This disorder affects about 5% of school-age children. The Cognitive Orientation to daily Occupational Performance (CO-OP) approach is a non-drug intervention technique, focused on solving motor problems where the patient is taught cognitive strategies (in small groups) with a view to acquire and execute motor coordination effectively. It is part of Cognitive-Behavioral techniques (CBT). This is one of the approaches recommended internationally and in France for patients with Developmental Coordination Disorder. In addition, for DCD patients, non-drug interventions in small groups are recommended internationally for this condition. However, few studies are available to validate the CO-OP approach in this format. Since 2013, the Department of Child and Adolescent Psychological Medicine sector 2 (MPEA2) of the University Hospital of Montpellier has offered group interventions for children diagnosed with DCD who are referred to them in current care practice with the CO-OP approach. In view of the major repercussions of DCD on self-esteem, academic and academic success and the development of social ties, this group therapy will restore a life trajectory and improve the quality of life of these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

January 4, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

December 28, 2021

Last Update Submit

July 23, 2024

Conditions

Keywords

Cognitive Orientation to daily Occupational Performance (CO-OP)Single Case Experimental Design (SCED)Developmental Coordination Disorder (DCD)Group intervention

Outcome Measures

Primary Outcomes (1)

  • Performance Quality Rating Scale (PQRS)

    The performance quality rating scale (PQRS) is an observational, video-based tool intended to measure the actual performance of individual client-selected activities. The PQRS is a Likert scale from 1 (very low performance) to 10 (very high performance) classically used in the literature on CO-OP.

    Up to 23 weeks

Secondary Outcomes (2)

  • Free tapping

    Up to 23 weeks

  • KIDSCREEN-27

    Up to 23 weeks

Study Arms (5)

Cognitive Orientation to daily Occupational Performance 1

EXPERIMENTAL

This arm is the first group composed of four childrens who will do the CO-OP. CO-OP uses cognitive problem solving techniques to facilitate motor skill acquisition. The therapist facilitates with guided discovery the child to generate solution for problems in their performance areas. The four patients will begin the sessions one week apart each.

Behavioral: Cognitive Orientation to daily Occupational Performance

Cognitive Orientation to daily Occupational Performance 2

EXPERIMENTAL

This arm is the second group composed of four others childrens who will do the CO-OP. CO-OP uses cognitive problem solving techniques to facilitate motor skill acquisition. The therapist facilitates with guided discovery the child to generate solution for problems in their performance areas The four patients will begin the sessions one week apart each.

Behavioral: Cognitive Orientation to daily Occupational Performance

Cognitive Orientation to daily Occupational Performance 3

EXPERIMENTAL

This arm is the third group composed of four others childrens who will do the CO-OP. CO-OP uses cognitive problem solving techniques to facilitate motor skill acquisition. The therapist facilitates with guided discovery the child to generate solution for problems in their performance areas The four patients will begin the sessions one week apart each.

Behavioral: Cognitive Orientation to daily Occupational Performance

Cognitive Orientation to daily Occupational Performance 4

EXPERIMENTAL

This arm is the fourth group composed of four others childrens who will do the CO-OP. CO-OP uses cognitive problem solving techniques to facilitate motor skill acquisition. The therapist facilitates with guided discovery the child to generate solution for problems in their performance areas The four patients will begin the sessions one week apart each.

Behavioral: Cognitive Orientation to daily Occupational Performance

Cognitive Orientation to daily Occupational Performance 5

EXPERIMENTAL

This arm is the fifth group composed of four others childrens who will do the CO-OP. CO-OP uses cognitive problem solving techniques to facilitate motor skill acquisition. The therapist facilitates with guided discovery the child to generate solution for problems in their performance areas The four patients will begin the sessions one week apart each.

Behavioral: Cognitive Orientation to daily Occupational Performance

Interventions

CO-OP uses cognitive problem solving techniques to facilitate motor skill acquisition. The therapist facilitates with guided discovery the child to generate solution for problems in their performance areas.

Cognitive Orientation to daily Occupational Performance 1Cognitive Orientation to daily Occupational Performance 2Cognitive Orientation to daily Occupational Performance 3Cognitive Orientation to daily Occupational Performance 4Cognitive Orientation to daily Occupational Performance 5

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of DCD formally established during a multidisciplinary assessment, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
  • years
  • Present in wait list for CO-OP intervention
  • Parents consent

You may not qualify if:

  • Language disorder
  • High level of anxious
  • Low level of motivation
  • Participation to another intervention
  • Subject refusal to participate
  • Parental refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Colombière (CHU)

Montpellier, 34000, France

Location

Related Publications (1)

  • Madieu E, Therriault PY, Cantin N, Baghdadli A. Effectiveness of CO-OP group intervention for children with developmental coordination disorder: single-case experimental design study protocol. BMJ Open. 2023 Dec 30;13(12):e073854. doi: 10.1136/bmjopen-2023-073854.

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Amaria BAGHDADLI

    MPEA2, Département Universitaire de Pédopsychiatrie, CHU de Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: The study design is similar to a matched case-control study using Single Case Experimental Design (SCED) methodology with a multiple baseline design across subjects.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2021

First Posted

February 9, 2022

Study Start

January 4, 2023

Primary Completion

January 10, 2024

Study Completion

July 10, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. Data will be made available to persons who address a reasonable dataset request to the principal investigator (c/o Emmanuel Madieu). In accordance with current regulations in France, the data may be made available after obtaining approvals from regulatory bodies (CPP, CESREES, CNIL, etc.). In accordance with GDPR, participants must be individually informed of the sharing of their data. The data will then be available via Nextcloud CHU tools. The data can then be used for all analyses.

Shared Documents
STUDY PROTOCOL
Time Frame
Datasets can be requested 24 month after the end of the study. The protocol will be made available after publication in scientific journal.
Access Criteria
The conditions under which members of the public will be granted access to datasets are: * The data will be used/examined in a not-for-profit manner; * The data will not be used in an attempt to identify a participant or group of participants; * The user does not work for a private insurance company; * The data will not be used in support of any kind of private insurance policy or health penalties; * The data will be used/examined for the advancement of science/teaching while respecting participant/patient privacy and rights; * The user will state why they wish to access the data. * The appropriate CNIL approval has been obtained by the user.

Locations