Home Within the Heart: a Playful Journey to Strengthen Family Resilience

NCT06592651 | Recruiting

• 1 other identifier: 003/24
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this clinical trial is to enhance open and secure communication within the family, strengthen the parent-child bond, and reinforce feelings of safety and stability, and strengthen family resilience. In addition,the investigators want to assess the effectiveness of a short-term therapeutic workshop in enhancing reflective functioning, beliefs about the malleability of emotions, the reported use of effective emotional regulation strategies, and the perceived parental self-efficacy and child behavior.

Conditions

Family Resilience; Short-term Therapy; The Integration of Narrative Therapy and Play Therapy

Keywords

Play therapy; Family Resilience; Reflective function; Situational anxiety; Children's mental well-being; Parental mental well-being

Outcome Measures

Primary Outcomes (1)

• Depression Anxiety Stress Scales-21 (DASS-21)

  DASS-21 is a widely used psychological assessment tool designed to measure the emotional states of depression, anxiety, and stress.Each item is scored on a 4-point Likert scale ranging from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time"). The scores for each subscale are summed and then multiplied by 2 to maintain consistency with the original DASS-42 scores.

  Up to 20 weeks

Secondary Outcomes (6)

• Mental Health Continuum-Short Form (MHC-SF)

  Up to 20 weeks

• Parental Reflective Functioning Questionnaire (PRFQ-18)

  Up to 20 weeks

• Political Life Events Exposure (PLE)

  Up to 20 weeks

• Stress Reaction Checklist (SRCL)

  Up to 20 weeks

• Child-Parent Relationship Scale - Short Form (CPRS-SF)

  Up to 20 weeks

Study Arms (1)

Parental Reflective Functioning intervention Group

EXPERIMENTAL

participants will attend four psycho-educational workshop sessions, where they will learn strategies for emotion regulation and mentalization to enhance open and secure communication within the family, strengthen the parent-child bond, and reinforce feelings of safety and stability.

Behavioral: Play Therapy Workshop

Interventions

Play Therapy Workshop BEHAVIORAL

4 session group intervention foucused on psycho-educational knowledge regarding tools for effective emotional coping with stressful events in the context of the "Iron Swords" war, focusing on building mental resilience in the parent-child dyad through play therapy. Each group consists of 5 parent-child dyads with children aged 3-6 years, who have been evacuated from war zones in the northern and southern regions of the country.

Parental Reflective Functioning intervention Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A parent who have been evacuated from war zones in the northern and southern regions of the country, and has a child of ages 3-6.

You may not qualify if:

• A parent under the age of 18.
• A parent who have not been evacuated from war zones.
• A parent who has a child under 3 years of age, or above 6 years of age.

Sponsors & Collaborators

• University of Haifa: lead

Study Sites (1)

University of Haifa

Haifa, 3103301, Israel

RECRUITING

Study Officials

• Yael Mayer, Phd

  University of Haifa

  PRINCIPAL INVESTIGATOR

• Yael Enav, Phd

  University of Haifa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yael Enav, PhD

CONTACT

72 50-726-1474; yaelenav12@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Emotiinal Regulation and Mentalization Lab

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: February 2, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 2 years after publication of the primary study results and will be available for 5 years.
• Access Criteria: Eligibility\*: Access restricted to reseachers affiliated with accredited academic institutions or healthcare organizations with relevant credentials. Application\*: Sumbit application form, research roposal, and CV to the principal investigator or designated contact. Review and Approval\*: Applications reviewed by the data access committee. Decision within 4-6 weeks. Conditions of Use\*: Data to be used solely for the approved project. Maintain confidentiality and data security. No third-party sharing withour approval. Publicatins and Reorting\*: Sumbit summary or findings within 12 months.Acknowledge original study in publications and provide copies to the principal investigator.

Locations

IL (1)