Family ResilienceNCT06592651
Home Within the Heart: a Playful Journey to Strengthen Family Resilience
A study testing Play Therapy Workshop in people with Family Resilience and Short-term Therapy, run by University of Haifa at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Family Resilience, Short-term Therapy, The Integration of Narrative Therapy and Play Therapy
- What is being tested?
- Play Therapy Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Feb 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
University of Haifa
Haifa, 3103301
Yael Enav, PhD, +972507261474, yaelenav@edu.haifa.ac.il
Yael Mayer, PhD, +972548234426, yael.mayer@edu.haifa.ac.il
About this study
Official title: 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.
Read the 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.
- Conditions
- Family Resilience, Short-term Therapy, The Integration of Narrative Therapy and Play Therapy
- Being tested
- Play Therapy Workshop
- Keywords
- Play therapy, Family Resilience, Reflective function, Situational anxiety, Children's mental well-being, Parental mental well-being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play Therapy WorkshopBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Play Therapy Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 20 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Feb 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family ResilienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yael Enav, University of Haifa
- Investigators
- Yael Mayer, Phd, Principal investigator, University of HaifaYael Enav, Phd, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592651
- Sponsor's protocol ID
- 003/24
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD excluding personal information given by participants in interview (records and transcripts), however coded information for these interview will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Within the Heart
- ClinicalTrials.gov ID
- NCT06592651
- Acronym / sponsor ID
- 003/24
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parental Reflective Functioning intervention Group | Experimental | Behavioral: Play Therapy Workshopparticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Play Therapy Workshop4 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. | Behavioural | Parental Reflective Functioning intervention Group |
Primary outcome
Depression Anxiety Stress Scales-21 (DASS-21)
Time frame: Up to 20 weeks
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.
6 secondary outcomes
Mental Health Continuum-Short Form (MHC-SF)
Time frame: Up to 20 weeks
Parental Reflective Functioning Questionnaire (PRFQ-18)
Time frame: Up to 20 weeks
Political Life Events Exposure (PLE)
Time frame: Up to 20 weeks
Stress Reaction Checklist (SRCL)
Time frame: Up to 20 weeks
Child-Parent Relationship Scale - Short Form (CPRS-SF)
Time frame: Up to 20 weeks
Brief Parental Self-Efficacy Scale (BPSES)
Time frame: Up to 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. All IPD excluding personal information given by participants in interview (records and transcripts), however coded information for these interview will be shared.
Related trials for Family Resilience
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
RecruitingPhase 3
Influence of Art Workshops and Cognitive Support for Families of Children With Cancer.
Psychologic Resilience
Recruiting
SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
Substance Abuse, Intimate Partner Violence (IPV)
Recruiting
Resilience-Building for Advance Care Planning
Advanced Cancer, End of Life
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yael Mayer, Phd principal investigator
University of Haifa
Yael Enav, Phd principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Play Therapy Workshop in people with Family Resilience and Short-term Therapy, run by University of Haifa at 1 site in Israel.
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 3 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yael Enav, PhD (72 50-726-1474, yaelenav12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Anxiety Stress Scales-21 (DASS-21) (time frame: Up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.