Oppositional Defiant DisorderREACTNCT05567276
Responding to Children and Adolescents With Tyrannical Behaviour
An observational study of Oppositional Defiant Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This was a randomized controlled trial that compared the NVR intervention group with a TAU group during a four-months period in reducing stress in parents of children aged 6-20 years and displaying severe tyrannical behaviour (STB). Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Oppositional Defiant Disorder
- What is being tested?
- Non-Violent Resistance parental training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2017to 30 Jul 2019
- Phase
- Observational
- 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 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Parents of children with STB aged 6-20 years old
Who may be able to join
- being the parent of a child aged 6 - 20 years who endorses the DSM-5 criteria of IODD. In fact, ODD is considered a necessary but not a sufficient condition for tyranny behavior
- two or more positive answers to the custom quetions routinely used to identify STB in children/adolescents at the University Hospital of Montpellier), related to a 12 month period :
- Are you afraid of your child?
- Is your child physically or psychologically violent toward you?
- Do you think that your child is the decision maker in the family?
- Do you feel ashamed by your situation at home?
- being able to attend half of the sessions.
Who cannot join
- predicted absence from at least half of the sessions
- subject deprived of liberty
- subject under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Violent Resistance Parental Training Versus Treatment as Usual for Children and Adolescents With Severe Tyrannical Behaviour: a Randomized Controlled Trial
This was a randomized controlled trial that compared the NVR intervention group with a TAU group during a four-months period in reducing stress in parents of children aged 6-20 years and displaying severe tyrannical behaviour (STB).
- Conditions
- Oppositional Defiant Disorder
- Being tested
- Non-Violent Resistance parental training
- Keywords
- Child-To-Parent Violence, Severe tyrannical behaviour, NVR, parental training program
- Medical subject headings
- Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Violent Resistance parental trainingBehavioural
Non-Violent Resistance parental training
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group : Non-Violent Resistance parental training (NVR) Receives: Behavioral: Non-Violent Resistance parental training | |
| Group 2 | Group 2 : Treatment as usual (TAU) = Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Stress Index/Short Form(PSI-SF)
Parenting Stress Index/Short Form(PSI-SF) : PSI-SF has 36 items based on a five-point Likert scale where each value corresponds to a specific statement (1 = completely disagree; 5 = completely agree). The subscale scores range from 12 to 60, and the Total Stress score ranges from 36 to 180. The higher the score, the greater the level of parental stress
Measured: 4 months from baseline
Secondary outcomes (4)
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) : HADS is a 14-item measure designed to assess anxiety and depression symptoms in adults. Items are rated on a 4-point severity scale. The HADS produces a scale for anxiety (HADS-A) and for depression (HADS-D). To screen for parental anxiety and depressive symptoms, the following interpretation can be proposed for each of the scores: scores of 7 or less are considered no symptomatology; scores between 8 and 10 are considered doubtful symptomatology; scores of 11 and more are considered definite symptomatology."
Measured: 4 months from baseline
Child Behaviour Checklist (CBCL)
Child Behaviour Checklist (CBCL) : CBCL has 115-item and uses T-scores which allows a wide-ranging evaluation of the child's behavioural profile.
Raw scores are calculated and used to generate T-scores for eight clinical subscales, two composite scales, one total scale, and four competence scales.
T-scores ≥70 are in the clinical range for the clinical subscales, T-scores ≥64 are in the clinical range for the composite scales and total scale, and T-scores ≤30 are in the clinical range for the competence scales. Emotional dysregulation was defined as an aggregate T-score of ≥210 on the Attention Problems, Aggressive Behavior, and Anxious/Depressed scales
Measured: 4 months from baseline
Strength and Difficulties Questionnaire (SDQ)
Strength and Difficulties Questionnaire (SDQ) : The SDQ consists of 5 subscales, each containing 5 items. The scales measure emotional symptoms, conduct problems, hyperactivity-inattention, peer relationship problems, and prosocial behaviours.
Each psychological attribute is scored on a 0-10 scale. A score of 0 is the best outcome concerning the emotional, conduct, hyperactivity, and peer relationship fields (note that these four attributes add up to a total difficulties/overall stress score scored on a 0-40 scale). This scoring reverses for pro-social/score for kind and helpful behaviour, where a score of 10 shows the least amount of difficulty
Measured: 4 months from baseline
Kiddie Schedule for Affective Disorders and Schizophrenia Present/Lifetime version
Kiddie Schedule for Affective Disorders and Schizophrenia Present/Lifetime
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Jul 2017
- Primary completion30 Mar 2019
- Study completion30 Jul 2019
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 Oppositional Defiant DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diane Purper-Ouakil, M.D., Ph. D., Study director, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567276
- Sponsor's protocol ID
- RECHMPL17_0155
- Acronym
- REACT
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Fongaro E, Aouinti S, Picot MC, Pupier F, Omer H, Franc N, Purper-Ouakil D. Non-violent resistance parental training versus treatment as usual for children and adolescents with severe tyrannical behavior: a randomized controlled trial. Front Psychiatry. 2023 May 4;14:1124028. doi: 10.3389/fpsyt.2023.1124028. eCollection 2023.
PubMed 37215679
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Violent Resistance Parental Training Versus Treatment as Usual for Children and Adolescents With Severe Tyrannical Behaviour: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05567276
- Acronym / sponsor ID
- REACT / RECHMPL17_0155
- Conditions
- Oppositional Defiant Disorder
- Keywords
- Child-To-Parent Violence, Severe tyrannical behaviour, NVR, parental training program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 5 Oct 2022 (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.
This was a randomized controlled trial that compared the NVR intervention group with a TAU group during a four-months period in reducing stress in parents of children aged 6-20 years and displaying severe tyrannical behaviour (STB).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: Non-Violent Resistance parental trainingGroup : Non-Violent Resistance parental training (NVR) |
| Group 2 | – | –Group 2 : Treatment as usual (TAU) = Control |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Parents of children with STB aged 6-20 years old
Key inclusion criteria (7 listed)
- being the parent of a child aged 6 - 20 years who endorses the DSM-5 criteria of IODD. In fact, ODD is considered a necessary but not a sufficient condition for tyranny behavior
- two or more positive answers to the custom quetions routinely used to identify STB in children/adolescents at the University Hospital of Montpellier), related to a 12 month period :
- being able to attend half of the sessions.
Key exclusion criteria (3 listed)
- predicted absence from at least half of the sessions
- subject deprived of liberty
- subject under guardianship or curatorship.
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 |
|---|---|---|
| Non-Violent Resistance parental trainingNon-Violent Resistance parental training | Behavioural | Group 1 |
Primary outcome
Parenting Stress Index/Short Form(PSI-SF)
Time frame: 4 months from baseline
Parenting Stress Index/Short Form(PSI-SF) : PSI-SF has 36 items based on a five-point Likert scale where each value corresponds to a specific statement (1 = completely disagree; 5 = completely agree). The subscale scores range from 12 to 60, and the Total Stress score ranges from 36 to 180. The higher the score, the greater the level of parental stress
4 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: 4 months from baseline
Child Behaviour Checklist (CBCL)
Time frame: 4 months from baseline
Strength and Difficulties Questionnaire (SDQ)
Time frame: 4 months from baseline
Kiddie Schedule for Affective Disorders and Schizophrenia Present/Lifetime version
Time frame: at baseline
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 5 Oct 2022.
- Derived from this study: PubMed 37215679Fongaro E, Aouinti S, Picot MC, Pupier F, Omer H, Franc N, Purper-Ouakil D. Non-violent resistance parental training versus treatment as usual for children and adolescents with severe tyrannical behavior: a randomized controlled trial. Front Psychiatry. 2023 May 4;14:1124028. doi: 10.3389/fpsyt.2023.1124028. eCollection 2023.
- Individual participant dataSharing planned: Undecided. NC
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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.
Diane Purper-Ouakil, M.D., Ph. D. study director
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oppositional Defiant Disorder, 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 7 inclusion and 3 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 5 Oct 2022. 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?
Parenting Stress Index/Short Form(PSI-SF) (time frame: 4 months from baseline). 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 NCT05567276, 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 5 Oct 2022.