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

August 26, 2026 updated by: Shahar Almog, Florida Atlantic University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shahar Almog, PhD
  • Phone Number: +1 (561) 2973461
  • Email: salmog@fau.edu

Study Contact Backup

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Tel Aviv University
        • Contact:
        • Principal Investigator:
          • Noga Tsur, PhD
  • United States
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Florida Atlantic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Dyadic (Child-Parent) Yoga
Behavioral: Dyadic (Child-Parent) Yoga
Participants will attend 8 weekly group sessions of dyadic (child and parent) yoga and engage in at-home practice at bedtime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child's Stress Symptoms
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child-Parent Relationship: Closeness
Time Frame: 8 weeks
The 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.
8 weeks
Child-Parent Relationship: Conflict
Time Frame: 8 weeks
The 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.
8 weeks
Parent's Stress Symptoms
Time Frame: 8 weeks
Presence 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.
8 weeks
Parent's Sleep Quality
Time Frame: 8 weeks
The 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.
8 weeks
Parental Self-Efficacy
Time Frame: 8 weeks
The 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.
8 weeks
Child's Pain Severity
Time Frame: 8 weeks
If 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.
8 weeks
Child's Pain Interference
Time Frame: 8 weeks
If 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.
8 weeks
Parent's Pain Severity
Time Frame: 8 weeks
If 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.
8 weeks
Parent's Pain Interference
Time Frame: 8 weeks
If 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.
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: Recruitment
Time Frame: Recruitment period, from initiation until the start day of the intervention
Recruitment will be calculated as the proportion of enrolled participants to interested individuals during the recruitment period.
Recruitment period, from initiation until the start day of the intervention
Feasibility: Intervention Retention
Time Frame: 8 weeks
Retention will be calculated as the proportion of participants who completed the intervention to participants who gave their consent to participate.
8 weeks
Feasibility: Intervention Adherence
Time Frame: 8 weeks
Percentage of participants completing at least 75% of the group sessions AND at least 4 at-home practices per week. Group session attendance will be monitored by the research team. At-home practice will be self-reported via a daily practice log.
8 weeks
Acceptability: Liking
Time Frame: 8 weeks
Parents will be asked if they liked the intervention on a scale of 0 to 10, with higher ratings indicating greater liking and better acceptability of the intervention among parents.
8 weeks
Acceptability: Recommending
Time Frame: 8 weeks
Parents will be asked about the likelihood that they would recommend the program to others, rated from 0 to 100%, with higher ratings indicating a greater likelihood of recommending the intervention and better acceptability of the intervention among parents.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida Atlantic University

Collaborators

Tel Aviv University

Investigators

  • Principal Investigator: Shahar Almog, PhD, Florida Atlantic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 5, 2026

Primary Completion (Estimated)

February 10, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

August 19, 2026

First Submitted That Met QC Criteria

August 26, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2602072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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