NCT06130852

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

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

Study Start

First participant enrolled

September 4, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

November 8, 2023

Last Update Submit

November 8, 2023

Conditions

Keywords

behavioral parent training

Outcome Measures

Primary Outcomes (2)

  • Motor Activity

    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

    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

Study Arms (2)

Behavioral Parent Training

EXPERIMENTAL

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.

Behavioral: Behavioral Parent Training

control group

NO INTERVENTION

no behavioral parent training

Interventions

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.

Behavioral Parent Training

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHToulouse

Toulouse Cedex9, 31059, France

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Yves CHAIX, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Non-pharmacological treatments focusing on parenting skills are found in many recommendations. Programs for families of children with behavioral problems (attention deficit hyperactivity disorder, oppositional defiant disorder or conduct disorder) have been developed in several countries and adapted to ADHD. These programs take a similar approach: providing information about the disorder, changing in parents' view of their child's disorders, and didactic techniques that are known to be effective. These treatments enable parents to regain confidence in their parenting role, thanks to means of analysis (ABC model) and action (behavioral tools, such as reinforcement practice, token economy, time-out).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 14, 2023

Study Start

September 4, 2021

Primary Completion

June 30, 2023

Study Completion

September 4, 2023

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations