Effectiveness of the Cognitive Orientation to Daily Occupational Performance Group Approach for Children With Developmental Coordination Disorder (DCD) - ECOOPG
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Performance Quality Rating Scale (PQRS)
Study Overview
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.
Detailed Description
Methodology:
The study design used is Single Case Experimental Design (SCED) methodology with multiple baseline design across subjects. The principle of SCED is based on the fact that each subject is his own control. The judgment criterion is repeated at least 5 times before initiating the intervention (Baseline phase), then repeated during the intervention (intervention phase) and after intervention (follow-up phase). It is the demonstration of 3 effects, represented here by at least 3 patients in parallel per group, which leads to the conclusion that the intervention is effective.
The children will be randomly integrated into the protocol according to the Wampold - Worsham procedure. Each child will be randomly assigned to the 4 potential positions, shifted in the multiple baseline plane of the SCED protocol of this study.
The SCED methodology uses an analysis of data and statistics specifics. The first phase of analysis will be a visual analysis of the differential between two contiguous phases on three specific aspects: the level, the trend and the variability of the dependent variable studied. Then, a statistical analysis specific to SCED protocols is possible. The use of random sequential introduction procedure such as Wampold - Worsham allows to extract a p value for each patient. This probability p is based on the rank of the mean corresponding to the real transitions among other hypothetical possible transitions of the SCED protocol. Then, the statistical analysis takes into account the overlap rate by calculating the number of overlapping points between the phases : the more overlap there is between two phases, the less the intervention effect is present. Conversely, if two phases show no overlap of measures, the intervention is likely to have a larger effect. Many overlap techniques exist. Those used for this study will be the "Non-overlap of All Pairs - NAP" technique, the Tau-U and Tau-U corrected from the baseline.
The main dependent variable is an evaluation of the performance level of target motor coordination worked for each patient in groups on video with the Performance Quality Rating Scales (PQRS). The PQRS is a 10-point Likert scale used to assess performance and change in performance directly during the patient's motor performance recorded on video for this study. The PQRS is a Likert scale from 1 (very poor performance) to 10 (very strong performance) conventionally used in the literature on CO-OP. The performance criteria will be determined for each point of the Likert scale a priori for each objective.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of DCD formally established during a multidisciplinary assessment, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
- •8-12 years
- •Present in wait list for CO-OP intervention
- •Parents consent
Exclusion Criteria
- •Language disorder
- •High level of anxious
- •Low level of motivation
- •Participation to another intervention
- •Subject refusal to participate
- •Parental refusal to participate
Outcomes
Primary Outcomes
Performance Quality Rating Scale (PQRS)
Time Frame: Up to 23 weeks
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.
Secondary Outcomes
- Free tapping(Up to 23 weeks)
- KIDSCREEN-27(Up to 23 weeks)