Clinical trial NCT06155162: The HuggyPuppy Intervention for War-related Distress
Official title: Efficacy of Parent-delivered HuggyPuppy Intervention for Reducing War-related Distress in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Related Disorder
Keywords: psychological intervention
war-related stress
pediatric
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Stress reactions
timeFrame: This measure will be completed by parents at pre- and 3-weeks post-intervention.
Secondary outcomes:
measure: Intervention adherence and satisfaction
timeFrame: Post-treatment only
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
References: