Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05567276
Other study ID # RECHMPL17_0155
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Completed NCT02485587 - Arousal-Biofeedback for the Treatment of Aggressive Behavior in Children and Adolescents N/A
Completed NCT00819429 - Supplements and Social Skills Intervention Study N/A
Completed NCT01085305 - The Effectiveness of Parent-Child Interaction Therapy (PCIT) N/A
Completed NCT00250354 - A Study of the Safety and Effectiveness of Risperidone for the Treatment of Conduct Disorder and Other Disruptive Behavior Disorders in Children Ages 5 to 12 With Mild, Moderate, or Borderline Mental Retardation Phase 3
Completed NCT05496140 - Remote School-Home Program to Improve Youth Attention and Behavior in Mexican Students N/A
Completed NCT05425966 - Adapting a Web-Based Professional Development for Mexican School Mental Health Providers Delivering Evidence-Based Intervention for ADHD and ODD N/A
Active, not recruiting NCT05049356 - Symptoms and Mechanisms of Child Psychiatric Disorders
Completed NCT03698240 - Mindfulness-based Program for Children With Disruptive Behavior Disorder N/A
Completed NCT02766101 - Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges N/A
Completed NCT00404911 - Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth N/A
Completed NCT00192023 - An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD). Phase 3
Completed NCT03292848 - Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders Phase 1
Recruiting NCT05637320 - Big Feelings: A Study on Children's Emotions in Therapy N/A
Recruiting NCT06373484 - Matching Assessment and Treatment for Children With Disruptive Behaviour and Their Parents N/A
Completed NCT03729154 - Preschool First Step to Success: An Efficacy Replication Study N/A
Completed NCT02281825 - Correlating Real and Virtual World Behavioral Fluctuations in Adolescence N/A
Completed NCT01822392 - On-line Treatment for Conduct Problems N/A
Completed NCT00406354 - Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany Phase 4
Completed NCT02783560 - Behavioral Sleep Intervention in Children With Disruptive Behaviors N/A