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CompletedNCT05567276REACTUpdated Oct 5, 2022

Responding to Children and Adolescents With Tyrannical Behaviour

An observational study in Oppositional Defiant Disorder, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 6 Years to 20 Years. Per ClinicalTrials.gov, last updated 2022-10-05.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
82
Ages
6 Years to 20 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Oppositional Defiant Disorder

Keywords

  • Child-To-Parent Violence
  • Severe tyrannical behaviour
  • NVR
  • parental training program
03

Who can participate

Ages eligible
6 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Parents of children with STB aged 6-20 years old

Inclusion criteria

  1. 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
  2. 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?
  3. being able to attend half of the sessions.

Exclusion criteria

Exclusion criteria:

  1. predicted absence from at least half of the sessions
  2. subject deprived of liberty
  3. subject under guardianship or curatorship.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
82 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • Group 1

    Group : Non-Violent Resistance parental training (NVR)

    Behavioral: Non-Violent Resistance parental training

  • Group 2

    Group 2 : Treatment as usual (TAU) = Control

Interventions

  • BehavioralNon-Violent Resistance parental training

    Non-Violent Resistance parental training

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 4 months from baseline

Secondary outcomes

  1. 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."

    Time frame: 4 months from baseline

  2. 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

    Time frame: 4 months from baseline

  3. 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

    Time frame: 4 months from baseline

  4. Kiddie Schedule for Affective Disorders and Schizophrenia Present/Lifetime version

    Kiddie Schedule for Affective Disorders and Schizophrenia Present/Lifetime

    Time frame: at baseline

06

Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
07

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05567276
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Oct 5, 2022
Start date
Jul 1, 2017
Primary completion
Mar 30, 2019
Completion
Jul 30, 2019
Last update
Oct 5, 2022

Study contacts

Diane Purper-Ouakil, M.D., Ph. D.
study director · UH Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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