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Behavioral Intervention

B-SAFE Program for Childhood Sleep Disorders

N/A
Recruiting
Research Sponsored by Candice A Alfano
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-months follow up
Awards & highlights

Study Summary

This trial will explore how to help foster kids get better sleep to cope with trauma. This could improve their long-term health & wellbeing.

Who is the study for?
This trial is for children aged 6-10 in foster care who have sleep problems at least twice a week. They must be living with their current foster family for at least one month, whether it's a non-relative or kinship placement.Check my eligibility
What is being tested?
The study tests the B-SAFE program, which adapts cognitive-behavioral treatment to improve sleep and overall adjustment for children in foster environments. It aims to help them recover from trauma by stabilizing their sleep patterns.See study design
What are the potential side effects?
Since B-SAFE is a behavioral intervention rather than medication, traditional side effects are not expected. However, changes in behavior or mood may occur as children adjust to new sleep routines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-months follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-months follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Emotional and behavioral regulation
Child average sleep onset latency (SOL)
Child average total sleep time (TST)
+3 more
Secondary outcome measures
Bedtime Routines Questionnaire (BRQ)
Children's Sleep Habits Questionnaire (CSHQ)
Pre-Sleep Arousal Scale for Children (PSAS-C)
Other outcome measures
Client Satisfaction Questionnaire (CSQ)
Homework Compliance
Parenting Stress Index -Short Form (PSI)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bolstering Sleep and Adjustment in Foster Environments (B-SAFE)Experimental Treatment1 Intervention
Brief, behavioral sleep intervention for children and caregivers
Group II: Delayed InterventionActive Control1 Intervention
Waitlist families will be monitored for 1 month before receiving the B-SAFE intervention

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Who is running the clinical trial?

Candice A AlfanoLead Sponsor
~17 spots leftby Jan 2025
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