Stress Related DisorderNCT06155162
The HuggyPuppy Intervention for War-related Distress
A study testing The HuggyPuppy Intervention: Original doll, The HuggyPuppy Intervention: Monkey doll and The HuggyPuppy Intervention: Dog without velcro doll in people with Stress Related Disorder, run by Tel Aviv University at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Stress Related Disorder
- What is being tested?
- The HuggyPuppy Intervention: Original doll, The HuggyPuppy Intervention: Monkey doll and The HuggyPuppy Intervention: Dog without velcro doll
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Nov 2023to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Parent-delivered HuggyPuppy Intervention for Reducing War-related Distress in Young Children
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.
Read the 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.
- Conditions
- Stress Related Disorder
- Being tested
- The HuggyPuppy Intervention: Original doll, The HuggyPuppy Intervention: Monkey doll, The HuggyPuppy Intervention: Dog without velcro doll, The HuggyPuppy Intervention: Bear doll, The HuggyPuppy Intervention: Rabbit doll
- Keywords
- psychological intervention, war-related stress, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The HuggyPuppy Intervention: Original dollBehavioural
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 dollBehavioural
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 dollBehavioural
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 dollBehavioural
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 dollBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Original HuggyPuppy doll | Experimental | The 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. Receives: Behavioral: The HuggyPuppy Intervention: Original doll |
| Monkey with velcro on paws, neutral expression | Experimental | A monkey doll with a neutral expression and with Velcro on its paws will be provided to children allocated to this treatment arm. Receives: Behavioral: The HuggyPuppy Intervention: Monkey doll |
| Dog without velcro on paws, neutral expression | Experimental | A puppy doll with a neutral expression and without Velcro on its paws will be provided to children allocated to this treatment arm. Receives: Behavioral: The HuggyPuppy Intervention: Dog without velcro doll |
| Bear, smiling | Experimental | A smiling bear doll with a neutral expression and without Velcro on its paws will be provided to children allocated to this treatment arm. Receives: Behavioral: The HuggyPuppy Intervention: Bear doll |
| Rabbit, neutral expression | Experimental | A bunny-rabbit doll with a neutral expression and without Velcro on its paws will be provided to children allocated to this treatment arm. Receives: Behavioral: The HuggyPuppy Intervention: Rabbit doll |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This measure will be completed by parents at pre- and 3-weeks post-intervention.
Secondary outcomes (1)
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.
Measured: Post-treatment only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start8 Nov 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Related DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Kahn, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155162
- Sponsor's protocol ID
- 0007481
- Status last verified
- Apr 2024
- First submitted
- 24 Nov 2023
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Parent-delivered HuggyPuppy Intervention for Reducing War-related Distress in Young Children
- ClinicalTrials.gov ID
- NCT06155162
- Acronym / sponsor ID
- 0007481
- Conditions
- Stress Related Disorder
- Keywords
- psychological intervention, war-related stress, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 4 Dec 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Original HuggyPuppy doll | Experimental | Behavioral: The HuggyPuppy Intervention: Original dollThe 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 | Experimental | Behavioral: The HuggyPuppy Intervention: Monkey dollA 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 | Experimental | Behavioral: The HuggyPuppy Intervention: Dog without velcro dollA puppy doll with a neutral expression and without Velcro on its paws will be provided to children allocated to this treatment arm. |
| Bear, smiling | Experimental | Behavioral: The HuggyPuppy Intervention: Bear dollA 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 | Experimental | Behavioral: The HuggyPuppy Intervention: Rabbit dollA bunny-rabbit doll with a neutral expression and without Velcro on its paws will be provided to children allocated to this treatment arm. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| The HuggyPuppy Intervention: Original dollThe 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. | Behavioural | Original HuggyPuppy doll |
| The HuggyPuppy Intervention: Monkey dollThe 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. | Behavioural | Monkey with velcro on paws, neutral expression |
| The HuggyPuppy Intervention: Dog without velcro dollThe 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. | Behavioural | Dog without velcro on paws, neutral expression |
| The HuggyPuppy Intervention: Bear dollThe 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. | Behavioural | Bear, smiling |
| The HuggyPuppy Intervention: Rabbit dollThe 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. | Behavioural | Rabbit, neutral expression |
Primary outcome
Stress reactions
Time frame: This measure will be completed by parents at pre- and 3-weeks post-intervention.
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.
1 secondary outcome
Intervention adherence and satisfaction
Time frame: Post-treatment only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The HuggyPuppy Intervention: Original doll, The HuggyPuppy Intervention: Monkey doll and The HuggyPuppy Intervention: Dog without velcro doll in people with Stress Related Disorder, run by Tel Aviv University 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 10 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress reactions (time frame: This measure will be completed by parents at pre- and 3-weeks post-intervention.). 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 10 Apr 2024.