Project Leo: Trauma-Informed Yoga for Preschool Children and Parents
1 other identifier
interventional
66
2 countries
2
Brief Summary
The goal of this pilot clinical trial is to examine feasibility, acceptability, and direction of effect of a dyadic (child and parent) trauma-informed yoga intervention on stress symptoms and sleep in young children (age 3-6) after war. The main questions it aims to answer are:
- Is the intervention feasible and liked by the participants?
- Does the child-parent yoga intervention reduce the child's stress symptoms and improve their sleep?
- Does the child-parent yoga intervention improve the child-parent relationship? Participants (child-parent dyads) will:
- Children and parents will participate together in 8 weekly group yoga sessions.
- Children and parents will engage together in a short daily at-home practice before bedtime.
- Parents will complete online surveys before and after the 8-week program, and at one-month follow-up.
- Parents will complete a daily practice-sleep log.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2026
Shorter than P25 for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
August 19, 2026
CompletedFirst Posted
Study publicly available on registry
August 27, 2026
CompletedStudy Start
First participant enrolled
October 5, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2027
Study Completion
Last participant's last visit for all outcomes
March 1, 2027
August 27, 2026
August 1, 2026
4 months
August 19, 2026
August 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Child's Stress Symptoms
Presence and severity of stress symptoms will be assessed (parent-reported) using the Young Child PTSD Checklist (YCPC). The 30-item scale yields a sum score ranging from 0 to 120, with higher scores indicating more severe stress symptoms.
8 weeks
Child's Sleep Quality
The child's sleep quality will be assessed (parent-reported) using the Children's Sleep Habits Questionnaire Abbreviated (CSHQ). The 22-item scale yields a sum score ranging from 0 to 88, with higher scores indicating more severe sleep problems.
8 weeks
Secondary Outcomes (9)
Child-Parent Relationship: Closeness
8 weeks
Child-Parent Relationship: Conflict
8 weeks
Parent's Stress Symptoms
8 weeks
Parent's Sleep Quality
8 weeks
Parental Self-Efficacy
8 weeks
- +4 more secondary outcomes
Other Outcomes (5)
Feasibility: Recruitment
Recruitment period, from initiation until the start day of the intervention
Feasibility: Intervention Retention
8 weeks
Feasibility: Intervention Adherence
8 weeks
- +2 more other outcomes
Study Arms (1)
Intervention
EXPERIMENTALDyadic (Child-Parent) Yoga
Interventions
Participants will attend 8 weekly group sessions of dyadic (child and parent) yoga and engage in at-home practice at bedtime.
Eligibility Criteria
You may qualify if:
- Children: Age 3-6. Per the parent's report, the child exhibits at least one stress-related symptom.
- Parents: Preferably, the same parent can attend all group sessions. Having internet access at home to complete online surveys.
You may not qualify if:
- Children: Any physical disability that prevents participating safely in yoga sessions.
- Parents: Self-reported pregnancy. Any physical disability that prevents participating safely in gentle yoga sessions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Florida Atlantic Universitylead
- Tel Aviv Universitycollaborator
Study Sites (2)
Florida Atlantic University
Boca Raton, Florida, 33431, United States
Tel Aviv University
Tel Aviv, Israel
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shahar Almog, PhD
Florida Atlantic University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Research Fellow
Study Record Dates
First Submitted
August 19, 2026
First Posted
August 27, 2026
Study Start (Estimated)
October 5, 2026
Primary Completion (Estimated)
February 10, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
August 27, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share