Deficit; AttentionPENDAHNCT06130852
Effects of Behavioral Training Groups for Parents of Children With Attention Deficit Hyperactivity Disorder
A study testing Behavioral Parent Training in people with Deficit; Attention, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Deficit; Attention
- What is being tested?
- Behavioral Parent Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2021to 4 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Deficit; Attention
- Being tested
- Behavioral Parent Training
- Keywords
- behavioral parent training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Parent TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Parent Training |
| control group | No intervention | no behavioral parent training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start4 Sep 2021
- Primary completion30 Jun 2023
- Study completion4 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deficit; AttentionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves CHAIX, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130852
- Sponsor's protocol ID
- RC31/20/0398
- Other IDs
- 2020-A02977-32
- Acronym
- PENDAH
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Workshops for Parents of Children With Attention Deficit Hyperactivity Disorder: Effects on the Child's Agitation. Preliminary Study.
- ClinicalTrials.gov ID
- NCT06130852
- Acronym / sponsor ID
- PENDAH / RC31/20/0398
- Conditions
- Deficit; Attention
- Keywords
- behavioral parent training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Behavioral Parent Training | Experimental | Behavioral: Behavioral Parent TrainingThis 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. |
| control group | No intervention | –no behavioral parent training |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Parent Training10 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. | Behavioural | Behavioral Parent Training |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves CHAIX, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Parent Training in people with Deficit; Attention, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Activity (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.