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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05086328
Other study ID # 2021 GV OUG
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2021
Est. completion date March 2024

Study information

Verified date October 2021
Source Universitair Ziekenhuis Brussel
Contact Bart Colson, MA
Phone 003224776072
Email bart.colson@uzbrussel.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Nonviolent Resistance (NVR) is an intervention method for families and teams that are suffering from helplessness and hopelessness. By empowering individuals through specific focus points and techniques, they can re-establish their role as authority figures for the child. The child, exhibiting dangerous and/or coercive behavior, can feel reconnected and guided. Previous research has shown that parents score higher on General family functioning, Affective reactions and affective involvement, and Role definitions, but not Behavioral control, Problem solving and Communication. Positive effects were visible at a follow up moment, three months later. Parents reported significantly lower on anxiety for the aggression of their child, the self-efficiency about parental capacities and received social support. General parenting stress diminished significantly. A control group showed no such significant changes. Participants with specific problems and waiting to be admitted in the residential ward at the study location can receive pre-care, in the form of a parental group training based on NVR. In six two weekly sessions, combined with intermediate telephone support and home assignments, parents are involved in important parent-child-oriented aspects. This study will evaluate the effect of the training in a Flemish sample, focusing on family functioning, parenting variables and reflective functioning of the parents, pre- and post-training. T1 is at the time between invitation to participate and the first session; T2 is in the first week after the last session (T1 + 12 to 14 weeks); T3 is at three months after the last session; T4 is at six months after the last session. The following primary outcomes are expected after the parent group: - More behavior and mental states pointing towards NVR - More use of adequate emotion regulation - Less behavioral problems in the child Secondary outcomes are expected, according to previous research measuring indirect effects of NVR treatment - More adequate attunement to child - More cohesion and structure in the family - More adequate parenting behavior - Less stress and burdening for parents The investigators also expect parents with a more secure attachment style to benefit more (T2) and longer (T3 and T4) from the training.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 64
Est. completion date March 2024
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: Parents engage in the NVR training of the child psychiatric clinic at the study location for at least 5 out of 6 training sessions Exclusion Criteria: - insufficient understanding of Dutch/Flemish language - simultaneously following a different parent group treatment, external to the study location

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium UZ Brussel Brussel

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

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

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

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. Review. — View Citation

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. 2021 Feb 2. doi: 10.1007/s00787-021-01723-8. [Epub a — View Citation

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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Change from baseline mean scores in attunement to the child as measured with the Parental Reflective Functioning Scale (PRFQ) The PRFQ measures reflective functioning or mentalizing, a process essential in developing a secure attachment and positive attunement to the child. There are three subscales with a 7-point scale: Pre-mentalizing (PM), Certainty about Mental States (CMS), and Interest and Curiosity in Mental States (IC). T1 baseline = 1 to 2 weeks before first session; T2 = T1 + 12 to 14 weeks; T3 = T2 + three months; T4 = T2 + six months
Secondary Change from baseline mean scores in family functioning as measured with the Questionnaire for Family Functioning (VGFO) The VGFO measures Basic care, Education, Social contacts, Youth experiences (of parents), and the Partner relationship, each on a 5-point scale. T1 baseline = 1 to 2 weeks before first session; T2 = T1 + 12 to 14 weeks; T3 = T2 + three months; T4 = T2 + six months
Secondary Change from baseline mean scores in parental burden as measured with the Parental Burden Questionnaire (OBVL) The OBVL measures possible sources of burden for parents in five scales: Parent-child relationship, Parenting competency, Depressed mood (of the parent), Role restriction, Health complaints, all on a 4-point scale. Higher scores mean more burden for the parents. T1 baseline = 1 to 2 weeks before first session; T2 = T1 + 12 to 14 weeks; T3 = T2 + three months; T4 = T2 + six months
Secondary Change from baseline mean scores in parental behavior as measured with the Short Scale for Parental Behavior (VSOG) The VSOG measures five different types of parental behavior on a 5-point scale: Positive engagement, Setting/teaching rules, Material rewarding, Punishing, and Physical punishment. T1 baseline = 1 to 2 weeks before first session; T2 = T1 + 12 to 14 weeks; T3 = T2 + three months; T4 = T2 + six months
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