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

Home Within the Heart

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.

Study Overview

• Status: Recruiting
• Conditions: Family Resilience; Short-term Therapy; The Integration of Narrative Therapy and Play Therapy
• Intervention / Treatment: Behavioral: Play Therapy Workshop

Detailed Description

The participants will:

Complete questionnaires and participate in clinical interviews regarding their relationship with their children and their mental functioning prior to the workshop.

The intervention group will engage in a 4-session workshop (held once a week) facilitated practitioners from various therapeutic disciplines, including clinical, educational, and developmental psychologists, as well as group facilitators.

During each session, observers document the quality of the interaction between the parent and child, focusing on aspects such as emotion, responsiveness, encouragement, and instruction.

After the workshop, participants will again complete questionnaires.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yael Enav, PhD; Phone Number: 72 50-726-1474; Email: yaelenav12@gmail.com

Study Locations

• Israel
  • Haifa, Israel, 3103301
    • Recruiting
    • University of Haifa
    • Contact: Yael Enav, PhD; Phone Number: +972507261474; Email: yaelenav@edu.haifa.ac.il
    • Contact: Yael Mayer, PhD; Phone Number: +972548234426; Email: yael.mayer@edu.haifa.ac.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Parental Reflective Functioning intervention Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental Health Continuum-Short Form (MHC-SF)	The MHC-SF is a shorter version of the Mental Health Continuum-Long Form (MHC-LF) and is designed to assess well-being across three dimensions: emotional well-being, social well-being, and psychological well-being.Each item is rated on a 6-point Likert scale, ranging from 0 ("never") to 5 ("every day"). The responses reflect the frequency of these positive experiences over the past month. Scores are calculated for each dimension, and a total score is obtained by summing the items. Higher scores indicate higher levels of well-being.	Up to 20 weeks
Parental Reflective Functioning Questionnaire (PRFQ-18)	The PRFQ-18 questionnaire consists of 18 items which respondents rate each item on a 7-point Likert scale, where higher scores indicate higher levels of reflective functioning.	Up to 20 weeks
Political Life Events Exposure (PLE)	Political Life Events Exposure will be measured using the PLE scale containing 20 items regarding injury to a family member as a result of war, terrorism or military circumstances. For each item, participants are asked to indicate if they were exposed over the past six months, and if so, how stressful it was for them on a 5-point Likert scale from 1 (not at all) to 5 (very stressful) .Two measures are calculated: objective exposure (the sum of events that individuals experience) and subjective exposure (the sum of ratings of the stress level associated with the event). There is no justification for calculating an internal consistency score for PLE, but test-retest reliability has revealed a high reliability of r=0.87.	Up to 20 weeks
Stress Reaction Checklist (SRCL)	The Stress Reaction Checklist (SRC) or Stress Reaction Checklist for Life Events (SRCL) is a psychological assessment tool designed to measure an individual's stress reactions following life events. This tool evaluates the cognitive, emotional, behavioral, and physical responses to stress, providing insights into how individuals cope with stressful situations.Responses are typically measured on a 5-point Likert scale,with higher scores indicating more severe or frequent stress reactions. The total score can be used to assess overall stress levels, while subscale scores can provide detailed information about specific types of stress responses.	Up to 20 weeks
Child-Parent Relationship Scale - Short Form (CPRS-SF)	The Child-Parent Relationship Scale - Short Form (CPRS-SF) consists of 15 items designed to assess the quality of the parent-child relationship. These items are divided into two subscales: Closeness Subscale and Conflict Subscale. Respondents (typically parents) rate each item on a Likert scale, often ranging from 1 (definitely does not apply) to 5 (definitely applies).The scale provides scores for the overall relationship quality as well as specific subscales for warmth, closeness, and conflict.	Up to 20 weeks
Brief Parental Self-Efficacy Scale (BPSES)	The BPSES typically consists of 6 to 10 items, although this can vary depending on the specific version used. Each item is rated on a 5-point Likert scale, often ranging from 1 (Strongly Disagree) to 5 (Strongly Agree), where parents indicate their level of agreement with statements about their parenting abilities.	Up to 20 weeks

Collaborators and Investigators

• Sponsor: University of Haifa
• Investigators: Principal Investigator: Yael Enav, Phd, University of Haifa; Principal Investigator: Yael Mayer, Phd, University of Haifa

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Estimated): September 12, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 15, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Play therapy; Reflective function; Family Resilience; Situational anxiety; Children's mental well-being; Parental mental well-being
• Other Study ID Numbers: 003/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD excluding personal information given by participants in interview (records and transcripts), however coded information for these interview will be shared.
• IPD Sharing Time Frame: Data will be available beginning 2 years after publication of the primary study results and will be available for 5 years.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No