Effects of Behavioral Training Groups for Parents of Children With Attention Deficit Hyperactivity Disorder (PENDAH)

November 8, 2023 updated by: University Hospital, Toulouse

Training Workshops for Parents of Children With Attention Deficit Hyperactivity Disorder: Effects on the Child's Agitation. Preliminary Study.

The therapeutic care of Attention Deficit Hyperactivity Disorder (ADHD) children focuses on the child but also on his environment and in particular his family. This type of approach has long existed in Anglo-Saxon countries. This project aims to collect preliminary data to build study to valid efficacy of a parenting skills program for parents of ADHD children in France and on the child's hyperactivity.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Toulouse cedex9, France, 31059
        • UHToulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
No Intervention: control group
no behavioral parent training

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.
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yves CHAIX, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

September 4, 2023

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Estimated)

November 14, 2023

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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