The HuggyPuppy Intervention for War-related Distress
Efficacy of Parent-delivered HuggyPuppy Intervention for Reducing War-related Distress in Young Children
1 other identifier
interventional
160
1 country
1
Brief Summary
This clinical trial will test the efficacy of parent-delivered HuggyPuppy Intervention in alleviating war-related stress in children aged 3-8 during the Gaza-Israel war. Moreover, it will test whether the type of doll provided moderates the efficacy of the intervention. Children will be provided a doll ('Huggy') of to their homes or places of shelter, and asked to take care of it. Five different types of dolls will be randomly assigned to children. Pre-intervention, parents will complete a brief questionnaire asking about the child's past week stress symptoms, and exposure to traumatic war-experiences. Three weeks following the intervention, parents will be asked to complete a post-intervention questionnaire, asking about the child's symptoms, their own anxiety, depression, and stress, as well as their use of the intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2023
CompletedFirst Submitted
Initial submission to the registry
November 24, 2023
CompletedFirst Posted
Study publicly available on registry
December 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2024
CompletedApril 10, 2024
April 1, 2024
4 months
November 24, 2023
April 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stress reactions
A stress reaction checklist (SRCL) will be used to assess children's level of stress-related symptoms. These include 15 items, such as "excessive crying", "experiencing nighttime awakenings or nightmares", and "frequently speaks about death". A general item pertaining to the child's level of distress on a 5-point scale will also be administered.
This measure will be completed by parents at pre- and 3-weeks post-intervention.
Secondary Outcomes (1)
Intervention adherence and satisfaction
Post-treatment only
Study Arms (5)
Original HuggyPuppy doll
EXPERIMENTALThe original puppy doll used in Sadeh et al., 2006 is a sad dog with Velcro on its paws will be provided to children allocated to this treatment arm.
Monkey with velcro on paws, neutral expression
EXPERIMENTALA monkey doll with a neutral expression and with Velcro on its paws will be provided to children allocated to this treatment arm.
Dog without velcro on paws, neutral expression
EXPERIMENTALA puppy doll with a neutral expression and without Velcro on its paws will be provided to children allocated to this treatment arm.
Bear, smiling
EXPERIMENTALA smiling bear doll with a neutral expression and without Velcro on its paws will be provided to children allocated to this treatment arm.
Rabbit, neutral expression
EXPERIMENTALA bunny-rabbit doll with a neutral expression and without Velcro on its paws will be provided to children allocated to this treatment arm.
Interventions
The HuggyPuppy Intervention, originally designed to alleviate war-related stress in children (Sadeh et al., 2006), is a concise psychosocial intervention featuring a soft plush toy, originally a puppy, accompanied by a 'cover story.' This narrative informs the child that 'Huggy' is seeking care, prompting the child to adopt and comfort the toy. In the parent-delivered version tested in this trial, parents will receive three instructional videos (each lasting 1.5-5 minutes), guiding them on introducing the doll to their child. These videos encourage parents to foster a strong bond between the child and the doll, emphasizing activities such as hugging and expressing emotions through this comforting companion.
The HuggyPuppy Intervention, originally designed to alleviate war-related stress in children (Sadeh et al., 2006), is a concise psychosocial intervention featuring a soft plush toy, originally a puppy, accompanied by a 'cover story.' This narrative informs the child that 'Huggy' is seeking care, prompting the child to adopt and comfort the toy. In this version children receive a plush monkey doll. In the parent-delivered version tested in this trial, parents will receive three instructional videos (each lasting 1.5-5 minutes), guiding them on introducing the doll to their child. These videos encourage parents to foster a strong bond between the child and the doll, emphasizing activities such as hugging and expressing emotions through this comforting companion.
The HuggyPuppy Intervention, originally designed to alleviate war-related stress in children (Sadeh et al., 2006), is a concise psychosocial intervention featuring a soft plush toy, originally a puppy, accompanied by a 'cover story.' This narrative informs the child that 'Huggy' is seeking care, prompting the child to adopt and comfort the toy. In this version children receive a plush dog doll, without velcro in palms. In the parent-delivered version tested in this trial, parents will receive three instructional videos (each lasting 1.5-5 minutes), guiding them on introducing the doll to their child. These videos encourage parents to foster a strong bond between the child and the doll, emphasizing activities such as hugging and expressing emotions through this comforting companion.
The HuggyPuppy Intervention, originally designed to alleviate war-related stress in children (Sadeh et al., 2006), is a concise psychosocial intervention featuring a soft plush toy, originally a puppy, accompanied by a 'cover story.' This narrative informs the child that 'Huggy' is seeking care, prompting the child to adopt and comfort the toy. In this version children receive a plush smiling bear doll. In the parent-delivered version tested in this trial, parents will receive three instructional videos (each lasting 1.5-5 minutes), guiding them on introducing the doll to their child. These videos encourage parents to foster a strong bond between the child and the doll, emphasizing activities such as hugging and expressing emotions through this comforting companion.
The HuggyPuppy Intervention, originally designed to alleviate war-related stress in children (Sadeh et al., 2006), is a concise psychosocial intervention featuring a soft plush toy, originally a puppy, accompanied by a 'cover story.' This narrative informs the child that 'Huggy' is seeking care, prompting the child to adopt and comfort the toy. In this version children receive a plush rabbit doll, with a neutral expression. In the parent-delivered version tested in this trial, parents will receive three instructional videos (each lasting 1.5-5 minutes), guiding them on introducing the doll to their child. These videos encourage parents to foster a strong bond between the child and the doll, emphasizing activities such as hugging and expressing emotions through this comforting companion.
Eligibility Criteria
You may qualify if:
- Child aged 3-8 years old
- Parents perceive child to be in distress due to the war (\<1 on a scale from 1-5, 1=not at all distressed, and 5=very high distress).
- Parent proficiency in Hebrew
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tel Aviv University
Tel Aviv, Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Parents will not be masked to the purpose of the intervention, but will be unaware that there are different types of dolls that are being tested.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior lecturer
Study Record Dates
First Submitted
November 24, 2023
First Posted
December 4, 2023
Study Start
November 8, 2023
Primary Completion
March 15, 2024
Study Completion
March 15, 2024
Last Updated
April 10, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will become available upon completion of recruitment.
- Access Criteria
- Request from Primary Investigator
The study protocol, analysis plan, all forms and measures, and the clinical report will be available to any requesting party, that plans to use this for educational or research purposes.