Responding to Children and Adolescents With Tyrannical Behaviour

Oppositional Defiant Disorder Clinical Trial

— REACT  

Official title:

Non-Violent Resistance Parental Training Versus Treatment as Usual for Children and Adolescents With Severe Tyrannical Behaviour: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05567276
• Other study ID #: RECHMPL17_0155
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: July 30, 2019

Study information

• Verified date: September 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 20 Years

Eligibility

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:

1. predicted absence from at least half of the sessions

2. subject deprived of liberty

3. subject under guardianship or curatorship.

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Oppositional Defiant Disorder

Intervention

Behavioral:
• Non-Violent Resistance parental training
Non-Violent Resistance parental training

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 months from baseline
Secondary	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."	4 months from baseline
Secondary	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	4 months from baseline
Secondary	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	4 months from baseline
Secondary	Kiddie Schedule for Affective Disorders and Schizophrenia Present/Lifetime version	Kiddie Schedule for Affective Disorders and Schizophrenia Present/Lifetime	at baseline