- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06130852
Effects of Behavioral Training Groups for Parents of Children With Attention Deficit Hyperactivity Disorder (PENDAH)
Training Workshops for Parents of Children With Attention Deficit Hyperactivity Disorder: Effects on the Child's Agitation. Preliminary Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Attention deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder affecting approximately 3-5% of an age group in France. Its manifestations affect individual in its everyday life. In 2014, the High Authority of the Health proposes recommendations for the children and the teenagers susceptible to present ADHD both for the screening and for the therapeutic. In this document, an important place is given to the family of these patients. Strong links are found between negative parental behaviours and a negative trajectory of ADHD symptomatology.
It seems essential to support and to guide these parents of children working in a different way, and for whom the specific educational approaches are known. Numerous counseling and parent training programs have been launched in the Anglo-Saxon countries since the 1980s. One of the most common methods is that proposed, which consists of a short therapy group, centered around a pedagogy on ADHD and its ecological consequences, as well as on the transmission of tools from behavioral theories aimed at reducing negative manifestations with the aim of improving relations between the ADHD children and his parents. This method come from a society different from ours and adaptation to French families is necessary. After several years of clinical experience in the care of ADHD children and their families, we developed a new program that draws heavily on the Barkley program for its beneficial effects, but combines the teaching of other recognized methods. We have been experimenting this program in current practice for 4 years at the CHU Toulouse at the rate of one session per year. At the moment, we only have family satisfaction evaluations. Nevertheless, the various Anglo-Saxon cognitive and behavioural programmes mentioned above show an overall improvement in the quality of life of families and in particular in the acceptance and management of everyday disorders.
The classically found effects are an improvement in the quality of life of families and in particular in the acceptance and management of disorders on a daily basis. Few or no effects are observed directly on the child using conventional assessment methods.
The main goal of this study is to collect preliminary data of the effects of the PENDAH Workshops on motor activity ADHD children.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Toulouse cedex9, France, 31059
- UHToulouse
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parents of children with mixed ADHD or hyperactive/impulsive according to DSM5 criteria (children will arrive with a pre-established diagnosis, verified and validated by a team doctor)
- Children aged 7 to 11 years (± 6 months)
- Existence of a parental complaint or a request for specific help in managing the child's daily problems
- Parents who have agreed to participate in the PENDAH program
- No opposition from both parents
- French language spoken and understood by workshop participants
Exclusion Criteria:
- Parental conflict incompatible with obtaining the non-opposition of both parents
- For the child and based on the DSM-5 criteria:
- Gille de la Tourette syndrome
- A conduct disorder
- Autism spectrum disorder
- A suspected or proven intellectual deficit based on the child's medical assessments sent to the investigating doctor
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Behavioral Parent Training
This program includes 10 thematic sessions aimed at changing the parent's view of their child by encouraging them to focus on appropriate behaviors. The sessions focus on specific themes such as positive attention, the principle of reinforcement, or even homework management. This program combines knowledge about ADHD with behavioral and cognitive techniques. |
10 thematic sessions aimed at changing the parent's view of their child by encouraging them to focus on appropriate behaviors.
The sessions focus on specific themes such as positive attention, the principle of reinforcement, or even homework management.
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No Intervention: control group
no behavioral parent training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor Activity
Time Frame: 5 months
|
Accelerometer was calibrated at 30 Hz. Data were poached at 60 seconds.
The variable used is the vector magnitude (VM), which accounts for accelerations of motion in the three planes of space and is expressed in counts/minute.
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5 months
|
|
Motor Activity
Time Frame: 10 months
|
Accelerometer was calibrated at 30 Hz. Data were poached at 60 seconds.
The variable used is the vector magnitude (VM), which accounts for accelerations of motion in the three planes of space and is expressed in counts/minute.
|
10 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yves CHAIX, MD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/20/0398
- 2020-A02977-32 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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