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

ConditionPost Traumatic Concerns
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3+
SponsorFlorida Atlantic University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Dyadic (Child-Parent) Yoga

    Behavioral

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

Treatment groups

66 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
8 weeks
2

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.

Time frame
8 weeks

Secondary outcomes

1

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.

Time frame
8 weeks
2

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.

Time frame
8 weeks
3

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.

Time frame
8 weeks
4

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.

Time frame
8 weeks

Other outcomes

1

Feasibility: Recruitment

Recruitment will be calculated as the proportion of enrolled participants to interested individuals during the recruitment period.

Time frame
Recruitment period, from initiation until the start day of the intervention
2

Feasibility: Intervention Retention

Retention will be calculated as the proportion of participants who completed the intervention to participants who gave their consent to participate.

Time frame
8 weeks
3

Feasibility: Intervention Adherence

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.

Time frame
8 weeks
4

Acceptability: Liking

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.

Time frame
8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florida Atlantic University

Lead sponsor

Tel Aviv University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: