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Project Leo: Trauma-Informed Yoga for Preschool Children and Parents

Project Leo: Trauma-Informed Yoga for Preschool Children and Parents

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07790588
Enrollment
66
Registered
2026-08-27
Start date
2026-10-05
Completion date
2027-03-01
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Concerns

Keywords

Post-trauma, Children, Yoga, Child-Parent Dyad

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.

Interventions

BEHAVIORALDyadic (Child-Parent) Yoga

Participants will attend 8 weekly group sessions of dyadic (child and parent) yoga and engage in at-home practice at bedtime.

Sponsors

Florida Atlantic University
Lead SponsorOTHER
Tel Aviv University
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Child's Sleep Quality8 weeksThe 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.
Child's Stress Symptoms8 weeksPresence 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.

Secondary

MeasureTime frameDescription
Child-Parent Relationship: Closeness8 weeksThe quality of the child-parent relationship will be assessed (parent-reported) using the Child-Parent Relationship Scale - Short Form (CPRS-SF), specifically the Closeness subscale. The 7-item subscale yields a sum score of 7 to 35, with higher scores indicating greater closeness. Higher closeness scores reflect better relationship between the child and the parent.
Child-Parent Relationship: Conflict8 weeksThe quality of the child-parent relationship will be assessed (parent-reported) using the Child-Parent Relationship Scale - Short Form (CPRS-SF), specifically the Conflict subscale. The 8-item subscale yields a sum score of 8 to 40, with higher scores indicating greater conflict. Lower conflict scores reflect better relationship between the child and the parent.
Parent's Stress Symptoms8 weeksPresence and severity of post-traumatic stress symptoms will be assessed (self-reported) using the PCL-5 scale. The 20-item scale yields a sum score ranging from 0 to 80, with higher scores indicating more severe post-traumatic stress symptoms.
Parent's Sleep Quality8 weeksThe parent's sleep quality will be assessed (self-reported) using the Sleep Disturbance PROMIS SF 8b. The 8-item scale yields a sum score ranging from 8 to 40, with higher scores indicating more severe sleep problems.
Parental Self-Efficacy8 weeksThe parent's self-confidence in their ability to handle their child's behavior problems will be assessed (self-reported) by the Brief Parental Self-Efficacy Scale. The 5-item scale yields a sum score ranging from 5 to 20, with higher scores indicating greater self-confidence.
Child's Pain Severity8 weeksIf the child experiences pain, pain severity will be assessed (parent-reported) using one item from the Brief Pain Inventory (BPI). Pain severity will be rated on a scale from 0 to 10, with higher rating indicating more severe pain.
Parent's Pain Severity8 weeksIf the parent experiences pain, pain severity will be assessed (self-reported) using one item from the Brief Pain Inventory (BPI). Pain severity will be rated on a scale from 0 to 10, with higher rating indicating more severe pain.
Child's Pain Interference8 weeksIf the child experiences pain, pain interference with routine activities will be assessed (parent-reported) using one item from the Brief Pain Inventory (BPI). The level of how much the pain interferes with routine activities will be rated on a scale from 0 to 10, with higher ratings indicating greater interference.
Parent's Pain Interference8 weeksIf the parent experiences pain, pain interference will be assessed (self-reported) using two items from the Brief Pain Inventory (BPI). The level of how much the pain interferes with (a) enjoyment in life and with (b) routine activities will be rated on a scale from 0 to 10, with higher ratings indicating greater interference.

Countries

Israel, United States

Contacts

CONTACTShahar Almog, PhD
salmog@fau.edu+1 (561) 2973461
CONTACTNoga Tsur, PhD
nogatsur@tauex.tau.ac.il
PRINCIPAL_INVESTIGATORShahar Almog, PhD

Florida Atlantic University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026