Post Traumatic ConcernsNCT07790588
Project Leo: Trauma-Informed Yoga for Preschool Children and Parents
A study testing Dyadic (Child-Parent) Yoga in people with Post Traumatic Concerns, run by Florida Atlantic University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Post Traumatic Concerns
- What is being tested?
- Dyadic (Child-Parent) Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Oct 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Noga Tsur, PhD contact
2 sites in 2 countries
United States1 site
Florida Atlantic University
Boca Raton, Florida, 33431
Israel1 site
Tel Aviv University
Tel Aviv
Noga Tsur, PhD, 0000000000, nogatsur@tauex.tau.ac.il
Noga Tsur, PhD
About this study
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?
Read more
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.
- Conditions
- Post Traumatic Concerns
- Being tested
- Dyadic (Child-Parent) Yoga
- Keywords
- Post-trauma, Children, Yoga, Child-Parent Dyad
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic (Child-Parent) YogaBehavioural
Participants will attend 8 weekly group sessions of dyadic (child and parent) yoga and engage in at-home practice at bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Dyadic (Child-Parent) Yoga Receives: Behavioral: Dyadic (Child-Parent) Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (9)
Child-Parent Relationship: Closeness
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.
Measured: 8 weeks
Child-Parent Relationship: Conflict
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.
Measured: 8 weeks
Parent's Stress Symptoms
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.
Measured: 8 weeks
Parent's Sleep Quality
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.
Measured: 8 weeks
Parental Self-Efficacy
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.
Measured: 8 weeks
Child's Pain Severity
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.
Measured: 8 weeks
Child's Pain Interference
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.
Measured: 8 weeks
Parent's Pain Severity
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.
Measured: 8 weeks
Parent's Pain Interference
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start5 Oct 2026 (estimated)
- Primary completion10 Feb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic ConcernsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Atlantic University
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Shahar Almog, Florida Atlantic University
- Investigators
- Shahar Almog, PhD, Principal investigator, Florida Atlantic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790588
- Sponsor's protocol ID
- IRB2602072
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Leo: Trauma-Informed Yoga for Preschool Children and Parents
- ClinicalTrials.gov ID
- NCT07790588
- Acronym / sponsor ID
- IRB2602072
- Conditions
- Post Traumatic Concerns
- Keywords
- Post-trauma, Children, Yoga, Child-Parent Dyad
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Florida Atlantic UniversityUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Aug 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Dyadic (Child-Parent) YogaDyadic (Child-Parent) Yoga |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Dyadic (Child-Parent) YogaParticipants will attend 8 weekly group sessions of dyadic (child and parent) yoga and engage in at-home practice at bedtime. | Behavioural | Intervention |
Primary outcome
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.
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.
9 secondary outcomes
Child-Parent Relationship: Closeness
Time frame: 8 weeks
Child-Parent Relationship: Conflict
Time frame: 8 weeks
Parent's Stress Symptoms
Time frame: 8 weeks
Parent's Sleep Quality
Time frame: 8 weeks
Parental Self-Efficacy
Time frame: 8 weeks
Child's Pain Severity
Time frame: 8 weeks
Child's Pain Interference
Time frame: 8 weeks
Parent's Pain Severity
Time frame: 8 weeks
Parent's Pain Interference
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Noga Tsur, PhD contact
Shahar Almog, PhD principal investigator
Florida Atlantic University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic (Child-Parent) Yoga in people with Post Traumatic Concerns, run by Florida Atlantic University at 2 sites in 2 countries.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shahar Almog, PhD (+1 (561) 2973461, salmog@fau.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child's Stress Symptoms (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 27 Aug 2026.