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Helplessness, LearnedNCT05086328

The Effect of Nonviolent Resistance in Parent Group Training in Child Psychiatric Care

An observational study of Helplessness, Learned and Family Conflict, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
What is being tested?
Nonviolent Resistance
How many people
64 participants
Where
1 siteBelgium
Study dates
Oct 2021to Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Bart Colson, MA contact

003224776072

bart.colson@uzbrussel.be

Edward Campforts, MD contact

003224776072

edward.campforts@uzbrussel.be

Belgium1 site

  • UZ Brussel

    Brussels

    Bart Colson, MA, 00324776072, bart.colson@uzbrussel.be

    Edward Campforts, MD, 00324776072, edward.campforts@uzbrussel.be

Other trials in Belgium

About this study

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.

Read the detailed 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.

Being tested
Nonviolent Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nonviolent ResistanceBehavioural

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

    Measured: 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)

  1. 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).

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2021
  2. Study startOct 2021 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05086328
Sponsor's protocol ID
2021 GV OUG
Status last verified
Oct 2021
First submitted
31 Aug 2021
Last updated
20 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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.

    PubMed 27292182

  • 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

  • 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.

    PubMed 33528659

  • 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.

    PubMed 25907660

Questions about this trial

What is this clinical trial studying?

An observational study of Helplessness, Learned and Family Conflict, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bart Colson, MA (003224776072, bart.colson@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline mean scores in four domains of Nonviolent Resistance as measured with the Parental Anchoring Scale (Flemish version) (time frame: T1 baseline = 1 to 2 weeks before first session; T2 = T1 + 12 to 14 weeks; T3 = T2 + three months; T4 = T2 + six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05086328, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.

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