Attention Deficit Disorder With HyperactivityDP-KIDNCT03176108
Evaluation of a Parent/Child Cognitive-Behaviorial Therapy Program in ADHD Children With Emotional Dysregulation Profile
A study testing Cognitive Behavorial Therapy (CBT) and Body mediation in people with Attention Deficit Disorder With Hyperactivity and Attention-Deficit-Disordered Children, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Attention Deficit Disorder (ADD) with or without Hyperactivity/Impulsivity (ADHD) is a neurodevelopmental syndrome that has a lasting impact on the child's daily lifestyle and leads to functional impairment. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Attention-Deficit-Disordered Children
- What is being tested?
- Cognitive Behavorial Therapy (CBT) and Body mediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2017to 28 Mar 2025
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents aged 7-13 years ;
- Children with a diagnostic of ADHD (diagnostics criteria from DSM-V);
- Score CBCL-DP ≥ 180 (" Aggressive behavior ", " Anxious-depression " and " Attention problems ") ;
- Children follow-up in Montpellier University Hospital ;
- Parents and children benefit of social security.
Who cannot join
- Children with a developmental delay or severe language disorder ;
- Families non-french speaking ;
- Absence of consent signed by parents and child ;
- Children not living with at least one parent.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Montpellier
Montpellier, 34295
Cécile VACHER, PHD, VACHER CECILE <c-vacher@chu-montpellier.fr>
Elodie COURTABESSIS, MD PHD, COURTABESSIS ELODIE <e-courtabessis@chu-montpellier.fr>
About this study
Official title: Evaluation of a Parent/Child Cognitive-Behaviorial Therapy Program in ADHD Children With Emotional Dysregulation Profile : a Study Prospective, Controlled and Randomized
Attention Deficit Disorder (ADD) with or without Hyperactivity/Impulsivity (ADHD) is a neurodevelopmental syndrome that has a lasting impact on the child's daily lifestyle and leads to functional impairment. ADHD is recognized as the most common psychiatry disorder in children and it's considered as a public health problem.
ADHD is frequently associated with a new diagnostic entity " Disruptive Disorder with Emotional dysregulation ". This disorder is characterized by crisis of anger with verbal or physical aggression, intensity disproportionate to the context and developmental age.
Read more
Few studies have examined the elements of emotional dysregulation in ADHD in children. Many studies have shown the interest of CBT in multimodal management of ADHD symptoms and associated disorders.
The main objective is to evaluate the effectiveness of a Cognitive-Behavioral Therapy Parent/Child program versus a body mediation focused on emotional and behaviorial aspects in ADD children aged 7-13 years with dimensional emotional dysregulation at 6 months after intervention. Secondary objectives are to evaluate the impact of this program, at short-term (at the end of CBT) and at 6 months after intervention, on socio-communicative capacities, quality of life, children's functioning and parental stress.
It's a biomedical research, prospective, controlled, randomized, monocentric, two parallels, with an evaluation of the criteria of blind judgment.
Read the detailed description
68 patients (parents and children) will be recruited within Montpellier University Hospital. They will be divided into a CBT group and a control group (body mediation).
The CBT group benefits from an intervention based on the program "Better manage its anger and its frustrations" of 15 sessions for the children.
The control group participates in an intervention of body mediation (theatre) of 15 session for the children.
The parents of CBT and Control groups participate in an CBT intervention of 8 sessions every 15 days.
- Being tested
- Cognitive Behavorial Therapy (CBT), Body mediation
- 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.
Cognitive Behavorial Therapy (CBT)Behavioural
Cognitive Behaviorial Therapy (CBT)
Body mediationBehavioural
Body mediation (theatre)
| Study group | Role | What they receive |
|---|---|---|
| CBT Group | Experimental | The CBT group benefits of an intervention based on the program "Better manage its anger and its frustrations" of 15 sessions for the children.
Parents participate in an CBT intervention of 8 sessions every 15 days. The session allow to develop adapted behaviors, to manage the disruptive behaviors and to improve the relations parents/children. Receives: Behavioral: Cognitive Behavorial Therapy (CBT) |
| Control Group | Sham comparator | The control group participates in an intervention of body mediation (theatre) of 15 session for the children.
Parents participate in an CBT intervention of 8 sessions every 15 days. The session allow to develop adapted behaviors, to manage the disruptive behaviors and to improve the relations parents/children. Receives: Behavioral: Body mediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation between the initial assessment and the month evaluation atfer the end of the intervention on the score of the " Aggressive behavior " subscale at the CBCL (Child Behavior Checklist)
The Questionnaire is completed by parents
Measured: Evaluation at inclusion, 6 months and 12 months
Secondary outcomes (7)
:* Variation of total score on CBCL and score on " Dysregulation profile " (CBCL-DP) on Child Behavior Checklist
The Questionnaire is completed by parents
Measured: Evaluation at inclusion, 6 months and 12 months
Variation of scores on " Strengths and Difficulties Questionnaire "
Description: The Questionnaire is completed by parents and teachers
Measured: Evaluation at inclusion, 6 months and 12 months
Variation of scores on " Parenting Stress Index "
The Questionnaire is completed by parents
Measured: Evaluation at inclusion, 6 months and 12 months
Variation of score on " Beck Depression Inventory "
The Questionnaire is completed by parents
Measured: Evaluation at inclusion, 6 months and 12 months
Variation of scores on " Kidscreen-27 "
The Questionnaire is completed by parents
Measured: Evaluation at inclusion, 6 months and 12 months
Variation of score on " PAR-ENT-Qol "
The Questionnaire is completed by parents
Measured: Evaluation at inclusion, 6 months and 12 months
Variation of score on " Children's Global Assessment Scale " (C-GAS)
The Questionnaire is completed by the evaluator who receive parents and their child.
Measured: Evaluation at inclusion, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start28 Jun 2017
- Primary completion28 Mar 2024 (estimated)
- Study completion28 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elodie COURTABESSIS, MD PHD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176108
- Sponsor's protocol ID
- 9729
- Acronym
- DP-KID
- Status last verified
- Jan 2023
- First submitted
- 30 May 2017
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vacher C, Romo L, Dereure M, Soler M, Picot MC, Purper-Ouakil D. Efficacy of cognitive behavioral therapy on aggressive behavior in children with attention deficit hyperactivity disorder and emotion dysregulation: study protocol of a randomized controlled trial. Trials. 2022 Feb 7;23(1):124. doi: 10.1186/s13063-022-05996-5.
PubMed 35130934
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Parent/Child Cognitive-Behaviorial Therapy Program in ADHD Children With Emotional Dysregulation Profile : a Study Prospective, Controlled and Randomized
- ClinicalTrials.gov ID
- NCT03176108
- Acronym / sponsor ID
- DP-KID / 9729
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 28 Mar 2024 (estimated)
- Study completion
- 28 Mar 2025 (estimated)
- First posted
- 5 Jun 2017 (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.
Attention Deficit Disorder (ADD) with or without Hyperactivity/Impulsivity (ADHD) is a neurodevelopmental syndrome that has a lasting impact on the child's daily lifestyle and leads to functional impairment. ADHD is recognized as the most common psychiatry disorder in children and it's considered as a public health problem.
ADHD is frequently associated with a new diagnostic entity " Disruptive Disorder with Emotional dysregulation ". This disorder is characterized by crisis of anger with verbal or physical aggression, intensity disproportionate to the context and developmental age.
Few studies have examined the elements of emotional dysregulation in ADHD in children. Many studies have shown the interest of CBT in multimodal management of ADHD symptoms and associated disorders.
The main objective is to evaluate the effectiveness of a Cognitive-Behavioral Therapy Parent/Child program versus a body mediation focused on emotional and behaviorial aspects in ADD children aged 7-13 years with dimensional emotional dysregulation at 6 months after intervention. Secondary objectives are to evaluate the impact of this program, at short-term (at the end of CBT) and at 6 months after intervention, on socio-communicative capacities, quality of life, children's functioning and parental stress.
It's a biomedical research, prospective, controlled, randomized, monocentric, two parallels, with an evaluation of the criteria of blind judgment.
Detailed description
68 patients (parents and children) will be recruited within Montpellier University Hospital. They will be divided into a CBT group and a control group (body mediation).
The CBT group benefits from an intervention based on the program "Better manage its anger and its frustrations" of 15 sessions for the children.
The control group participates in an intervention of body mediation (theatre) of 15 session for the children.
The parents of CBT and Control groups participate in an CBT intervention of 8 sessions every 15 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT Group | Experimental | Behavioral: Cognitive Behavorial Therapy (CBT)The CBT group benefits of an intervention based on the program "Better manage its anger and its frustrations" of 15 sessions for the children. Parents participate in an CBT intervention of 8 sessions every 15 days. The session allow to develop adapted behaviors, to manage the disruptive behaviors and to improve the relations parents/children. |
| Control Group | Sham comparator | Behavioral: Body mediationThe control group participates in an intervention of body mediation (theatre) of 15 session for the children. Parents participate in an CBT intervention of 8 sessions every 15 days. The session allow to develop adapted behaviors, to manage the disruptive behaviors and to improve the relations parents/children. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children and adolescents aged 7-13 years ;
- Children with a diagnostic of ADHD (diagnostics criteria from DSM-V);
- Score CBCL-DP ≥ 180 (" Aggressive behavior ", " Anxious-depression " and " Attention problems ") ;
- Children follow-up in Montpellier University Hospital ;
- Parents and children benefit of social security.
Key exclusion criteria (4 listed)
- Children with a developmental delay or severe language disorder ;
- Families non-french speaking ;
- Absence of consent signed by parents and child ;
- Children not living with at least one parent.
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 |
|---|---|---|
| Cognitive Behavorial Therapy (CBT)Cognitive Behaviorial Therapy (CBT) | Behavioural | CBT Group |
| Body mediationBody mediation (theatre) | Behavioural | Control Group |
Primary outcome
Variation between the initial assessment and the month evaluation atfer the end of the intervention on the score of the " Aggressive behavior " subscale at the CBCL (Child Behavior Checklist)
Time frame: Evaluation at inclusion, 6 months and 12 months
The Questionnaire is completed by parents
7 secondary outcomes
:* Variation of total score on CBCL and score on " Dysregulation profile " (CBCL-DP) on Child Behavior Checklist
Time frame: Evaluation at inclusion, 6 months and 12 months
Variation of scores on " Strengths and Difficulties Questionnaire "
Time frame: Evaluation at inclusion, 6 months and 12 months
Variation of scores on " Parenting Stress Index "
Time frame: Evaluation at inclusion, 6 months and 12 months
Variation of score on " Beck Depression Inventory "
Time frame: Evaluation at inclusion, 6 months and 12 months
Variation of scores on " Kidscreen-27 "
Time frame: Evaluation at inclusion, 6 months and 12 months
Variation of score on " PAR-ENT-Qol "
Time frame: Evaluation at inclusion, 6 months and 12 months
Variation of score on " Children's Global Assessment Scale " (C-GAS)
Time frame: Evaluation at inclusion, 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Derived from this study: PubMed 35130934Vacher C, Romo L, Dereure M, Soler M, Picot MC, Purper-Ouakil D. Efficacy of cognitive behavioral therapy on aggressive behavior in children with attention deficit hyperactivity disorder and emotion dysregulation: study protocol of a randomized controlled trial. Trials. 2022 Feb 7;23(1):124. doi: 10.1186/s13063-022-05996-5.
- 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.
Elodie COURTABESSIS, MD PHD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavorial Therapy (CBT) and Body mediation in people with Attention Deficit Disorder With Hyperactivity and Attention-Deficit-Disordered Children, run by University Hospital, Montpellier 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Jan 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecile VACHER, Psychologist (+33.4.64.33.71.97, c-vacher@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation between the initial assessment and the month evaluation atfer the end of the intervention on the score of the " Aggressive behavior " subscale at the CBCL (Child Behavior Checklist) (time frame: Evaluation at inclusion, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03176108, which also lists 1 linked publication.
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 23 Jan 2023.