The HuggyPuppy Intervention for War-related Distress

Stress Related Disorder Clinical Trial

Official title:

Efficacy of Parent-delivered HuggyPuppy Intervention for Reducing War-related Distress in Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06155162
• Other study ID #: 0007481
• Status: Completed
• Phase: N/A
• Start date: November 8, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: April 2024
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The goal of this clinical trial is to test the efficacy of parent-delivered HuggyPuppy Intervention in alleviating war-related stress in children aged 3-8 during the Gaza-Israel war. The trial also aims to examine whether the type of doll provided moderates the efficacy of the intervention, and whether parent and child attachment to the doll and adherence to the intervention are associated with its outcomes.

Participants will be 160 children aged 3-8 from across Israel, whose parents perceive them to be distressed due to the war. Parents will undergo a brief phone interview to confirm the child's age and distress level. Subsequently, parents will be directed to complete a concise online survey, detailing their child's stress symptoms over the past week and exposure to traumatic war experiences. Demographic information, such as parent marital status, will also be collected.

The HuggyPuppy Intervention will then be delivered to all children via their parents. This brief psychosocial intervention was originally developed to reduce war-related stress in children (Sadeh et al., 2006). It involves a soft plush toy - originally a puppy - provided to the child along with a 'cover story', telling the child that 'Huggy' (the puppy) is far from home and looking for someone to look after it. The child is then asked to adopt Huggy, and take care of it when it is sad and lonely.

Children will be randomly assigned to receive one of five different types of dolls (dog with Velcro in palms, dog without Velcro in palms, monkey with Velcro in palms, bear, and rabbit). The doll will be delivered to their homes or places of shelter. During the course of 1 week of intervention, parents will receive three instructional videos (each lasting 1.5-5 minutes), guiding them on how to introduce the doll to their child. They will be encouraged to nurture a bond between the child and the doll, promoting activities like hugging and expressing emotions through it. Three weeks after the intervention, parents will be requested to complete a post-intervention questionnaire. This questionnaire will cover the child's symptoms, as well as the parent's anxiety, depression, and stress levels. Additionally, parents will provide feedback on their adherence to and experiences with the intervention.

The expected results of this study will provide empirical evidence on the effectiveness of the parent-delivered HuggyPuppy Intervention in ameliorating war-related stress in young children. Moreover, the study aims to enhance our understanding of potential moderating factors, such as the type of doll provided, and shed light on the crucial role of parent and child attachment to the intervention, offering valuable insights for the development of targeted interventions in the context of conflict-related stress.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Stress Related Disorder

Intervention

Behavioral:
• The HuggyPuppy Intervention: Original doll
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: Monkey doll
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: Dog without velcro doll
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: Bear doll
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: Rabbit doll
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.

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intervention adherence and satisfaction	Parents will complete a series of questions about their use and experience of the intervention. Items will refer to child attachment to the doll, and parent perception of and compliance with instructions (e.g., watching all 3 instructional videos), as well as their satisfaction with the intervention.	Post-treatment only