- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05567276
Responding to Children and Adolescents With Tyrannical Behaviour (REACT)
Non-Violent Resistance Parental Training Versus Treatment as Usual for Children and Adolescents With Severe Tyrannical Behaviour: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Montpellier, France, 34295
- Uhmontpellier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- predicted absence from at least half of the sessions
- subject deprived of liberty
- subject under guardianship or curatorship.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Group : Non-Violent Resistance parental training (NVR)
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Non-Violent Resistance parental training
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Group 2
Group 2 : Treatment as usual (TAU) = Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 months from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 4 months from baseline
|
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."
|
4 months from baseline
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Child Behaviour Checklist (CBCL)
Time Frame: 4 months from baseline
|
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 |
4 months from baseline
|
Strength and Difficulties Questionnaire (SDQ)
Time Frame: 4 months from baseline
|
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 |
4 months from baseline
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Kiddie Schedule for Affective Disorders and Schizophrenia Present/Lifetime version
Time Frame: at baseline
|
Kiddie Schedule for Affective Disorders and Schizophrenia Present/Lifetime
|
at baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL17_0155
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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