NCT05086328

Brief Summary

In a Flemish sample of parents of children with psychiatric problems, this study evaluates the effect of a parent group training based on nonviolent resistance on family functioning, parenting variables and mental states of the parents, pre- and post-training.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

2.2 years

First QC Date

August 31, 2021

Last Update Submit

October 7, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change from baseline mean scores in four domains of Nonviolent Resistance as measured with the Parental Anchoring Scale (Flemish version)

    The Parental Anchoring Questionnaire (Flemish version = OAFS) measures Presence, Self-Control, Social Support, and Structure, on a 7-point scale. High scores mean more Nonviolent Resistance.

    T1 baseline = 1 to 2 weeks before first session; T2 = T1 + 12 to 14 weeks; T3 = T2 + three months; T4 = T2 + six months

  • Change from baseline mean scores in child behavior as measured with the Child Behavior Checklist (CBCL)

    The CBCL is a general questionnaire measuring internalizing and externalizing behavior of the child as perceived by the parents, using a 3-point scale. High scores mean more problems.

    T1 baseline = 1 to 2 weeks before first session; T2 = T1 + 12 to 14 weeks; T3 = T2 + three months; T4 = T2 + six months

  • Change from baseline mean scores in emotion regulation as measured with the Emotion Regulation Questionnaire (ERQ)

    The ERQ measures Reappraisal and Suppression as two distinct mechanisms to deal with emotional problems. Reappraisal is related more with healthy coping. A 7-point scale leads to scores pointing to high Reappraisal and high Suppression.

    T1 baseline = 1 to 2 weeks before first session; T2 = T1 + 12 to 14 weeks; T3 = T2 + three months; T4 = T2 + six months

Secondary Outcomes (4)

  • Change from baseline mean scores in attunement to the child as measured with the Parental Reflective Functioning Scale (PRFQ)

    T1 baseline = 1 to 2 weeks before first session; T2 = T1 + 12 to 14 weeks; T3 = T2 + three months; T4 = T2 + six months

  • Change from baseline mean scores in family functioning as measured with the Questionnaire for Family Functioning (VGFO)

    T1 baseline = 1 to 2 weeks before first session; T2 = T1 + 12 to 14 weeks; T3 = T2 + three months; T4 = T2 + six months

  • Change from baseline mean scores in parental burden as measured with the Parental Burden Questionnaire (OBVL)

    T1 baseline = 1 to 2 weeks before first session; T2 = T1 + 12 to 14 weeks; T3 = T2 + three months; T4 = T2 + six months

  • Change from baseline mean scores in parental behavior as measured with the Short Scale for Parental Behavior (VSOG)

    T1 baseline = 1 to 2 weeks before first session; T2 = T1 + 12 to 14 weeks; T3 = T2 + three months; T4 = T2 + six months

Interventions

Six two weekly sessions of two hours, based on nonviolent resistance Questionnaires pre and post intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- parents of child on the waiting list or already admitted for help in the child psychiatric clinic at the study location, with specific parental stress related to helplessness

You may qualify if:

  • Parents engage in the NVR training of the child psychiatric clinic at the study location for at least 5 out of 6 training sessions

You may not qualify if:

  • insufficient understanding of Dutch/Flemish language
  • simultaneously following a different parent group treatment, external to the study location

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Brussels, Belgium

Location

Related Publications (6)

  • Sherman, E. (2018). Group-Based Nonviolent Resistance Program: Development of a Short-Term Intervention and Preliminary Assessment of Its Feasibility and Acceptance. Tel Aviv University, Master Thesis

    BACKGROUND
  • Omer H, Lebowitz ER. Nonviolent Resistance: Helping Caregivers Reduce Problematic Behaviors in Children and Adolescents. J Marital Fam Ther. 2016 Oct;42(4):688-700. doi: 10.1111/jmft.12168. Epub 2016 Jun 13.

    PMID: 27292182BACKGROUND
  • Kiliçarslan, S. (2019). The Effect of the Non-violent Resistance Program for the Parents of Children with Violent Behaviors. Kastamonu Education, 27(2), 701-716. https://doi.org/10.24106/kefdergi.2691

    RESULT
  • Kiliçarslani, S., Ördem, S., Taltekin, A. & Ardiç, R. (2019). The Effect of Non-Violent Resistance Program on Family Relationships and Parentship Perceptions of Parents. PAU Journal of Education, 45, 211-234. doi: 10.9779/PUJE.2018.230

    RESULT
  • Schorr-Sapir I, Gershy N, Apter A, Omer H. Parent training in non-violent resistance for children with attention deficit hyperactivity disorder: a controlled outcome study. Eur Child Adolesc Psychiatry. 2022 Jun;31(6):929-938. doi: 10.1007/s00787-021-01723-8. Epub 2021 Feb 2.

  • Van Holen F, Vanderfaeillie J, Omer H. Adaptation and Evaluation of a Nonviolent Resistance Intervention for Foster Parents: A Progress Report. J Marital Fam Ther. 2016 Apr;42(2):256-71. doi: 10.1111/jmft.12125. Epub 2015 Apr 24.

Study Officials

  • Bart Colson, MA

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

August 31, 2021

First Posted

October 20, 2021

Study Start

October 1, 2021

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

October 20, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations