NCT05567276

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
Last Updated

October 5, 2022

Status Verified

September 1, 2022

Enrollment Period

1.7 years

First QC Date

September 23, 2022

Last Update Submit

September 30, 2022

Conditions

Keywords

Child-To-Parent ViolenceSevere tyrannical behaviourNVRparental training program

Outcome Measures

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

    4 months from baseline

Secondary Outcomes (4)

  • Hospital Anxiety and Depression Scale (HADS)

    4 months from baseline

  • Child Behaviour Checklist (CBCL)

    4 months from baseline

  • Strength and Difficulties Questionnaire (SDQ)

    4 months from baseline

  • Kiddie Schedule for Affective Disorders and Schizophrenia Present/Lifetime version

    at baseline

Study Arms (2)

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

Non-Violent Resistance parental training

Group 1

Eligibility Criteria

Age6 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Parents of children with STB aged 6-20 years old

You may qualify if:

  • 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.

You may not qualify if:

  • predicted absence from at least half of the sessions
  • subject deprived of liberty
  • subject under guardianship or curatorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: NONE RETAINED

NC

MeSH Terms

Conditions

Oppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Diane Purper-Ouakil, M.D., Ph. D.

    UH Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2022

First Posted

October 5, 2022

Study Start

July 1, 2017

Primary Completion

March 30, 2019

Study Completion

July 30, 2019

Last Updated

October 5, 2022

Record last verified: 2022-09

Locations