Project Leo: Trauma-Informed Yoga for Preschool Children and Parents
26 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
66
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Shahar Almog, PhD
- Telefonnummer: +1 (561) 2973461
- E-post: salmog@fau.edu
Studera Kontakt Backup
- Namn: Noga Tsur, PhD
- E-post: nogatsur@tauex.tau.ac.il
Studieorter
-
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Florida
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Boca Raton, Florida, Förenta staterna, 33431
- Florida Atlantic University
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-
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-
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Tel Aviv, Israel
- Tel Aviv University
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Kontakt:
- Noga Tsur, PhD
- Telefonnummer: 0000000000
- E-post: nogatsur@tauex.tau.ac.il
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Huvudutredare:
- Noga Tsur, PhD
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Intervention
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Child's Stress Symptoms
Tidsram: 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.
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8 weeks
|
|
Child's Sleep Quality
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Child-Parent Relationship: Closeness
Tidsram: 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.
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8 weeks
|
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Child-Parent Relationship: Conflict
Tidsram: 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
Tidsram: 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
|
|
Parent's Sleep Quality
Tidsram: 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.
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8 weeks
|
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Parental Self-Efficacy
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Feasibility: Recruitment
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Shahar Almog, PhD, Florida Atlantic University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
5 oktober 2026
Primärt slutförande (Beräknad)
10 februari 2027
Avslutad studie (Beräknad)
1 mars 2027
Studieregistreringsdatum
Först inskickad
19 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
26 augusti 2026
Första postat (Faktisk)
27 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB2602072
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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