Dyadic (Child-Parent) Yoga
BehavioralParticipants will attend 8 weekly group sessions of dyadic (child and parent) yoga and engage in at-home practice at bedtime.
NCT Number: NCT07790588
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 opening soon.
Get Notified3 year and older
All sexes
Interventional
Not applicable
Tel Aviv University, Tel Aviv, Israel
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Participants will attend 8 weekly group sessions of dyadic (child and parent) yoga and engage in at-home practice at bedtime.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Noga Tsur, PhD
CONTACT
Shahar Almog, PhD
CONTACT
Florida Atlantic University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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