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Completed

NCT Number: NCT06130852

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

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.

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Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHToulouse

Toulouse Cedex9, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Parent Training

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: PENDAH

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2023
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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