Project Leo: Trauma-Informed Yoga for Preschool Children and Parents
26 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
66
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Shahar Almog, PhD
- Telefoonnummer: +1 (561) 2973461
- E-mail: salmog@fau.edu
Studie Contact Back-up
- Naam: Noga Tsur, PhD
- E-mail: nogatsur@tauex.tau.ac.il
Studie Locaties
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Tel Aviv, Israël
- Tel Aviv University
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Contact:
- Noga Tsur, PhD
- Telefoonnummer: 0000000000
- E-mail: nogatsur@tauex.tau.ac.il
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Hoofdonderzoeker:
- Noga Tsur, PhD
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Florida
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Boca Raton, Florida, Verenigde Staten, 33431
- Florida Atlantic University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Intervention
Dyadic (Child-Parent) Yoga
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Participants will attend 8 weekly group sessions of dyadic (child and parent) yoga and engage in at-home practice at bedtime.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Child's Stress Symptoms
Tijdsspanne: 8 weeks
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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.
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8 weeks
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Child's Sleep Quality
Tijdsspanne: 8 weeks
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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.
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8 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Child-Parent Relationship: Closeness
Tijdsspanne: 8 weeks
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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.
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8 weeks
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Child-Parent Relationship: Conflict
Tijdsspanne: 8 weeks
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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.
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8 weeks
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Parent's Stress Symptoms
Tijdsspanne: 8 weeks
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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.
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8 weeks
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Parent's Sleep Quality
Tijdsspanne: 8 weeks
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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.
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8 weeks
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Parental Self-Efficacy
Tijdsspanne: 8 weeks
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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.
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8 weeks
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Child's Pain Severity
Tijdsspanne: 8 weeks
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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.
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8 weeks
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Child's Pain Interference
Tijdsspanne: 8 weeks
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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.
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8 weeks
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Parent's Pain Severity
Tijdsspanne: 8 weeks
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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.
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8 weeks
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Parent's Pain Interference
Tijdsspanne: 8 weeks
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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.
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8 weeks
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Feasibility: Recruitment
Tijdsspanne: Recruitment period, from initiation until the start day of the intervention
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Recruitment will be calculated as the proportion of enrolled participants to interested individuals during the recruitment period.
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Recruitment period, from initiation until the start day of the intervention
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Feasibility: Intervention Retention
Tijdsspanne: 8 weeks
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Retention will be calculated as the proportion of participants who completed the intervention to participants who gave their consent to participate.
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8 weeks
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Feasibility: Intervention Adherence
Tijdsspanne: 8 weeks
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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.
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8 weeks
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Acceptability: Liking
Tijdsspanne: 8 weeks
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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.
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8 weeks
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Acceptability: Recommending
Tijdsspanne: 8 weeks
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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.
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8 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Shahar Almog, PhD, Florida Atlantic University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
5 oktober 2026
Primaire voltooiing (Geschat)
10 februari 2027
Studie voltooiing (Geschat)
1 maart 2027
Studieregistratiedata
Eerst ingediend
19 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
26 augustus 2026
Eerst geplaatst (Werkelijk)
27 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
26 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB2602072
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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