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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-months follow up

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Candice A AlfanoLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for participation in this experiment at present?

"Affirmative, clinicaltrials.gov corroborates that this medical trial is actively recruiting patients. It was initially unveiled on January 1st 2023 and its most recent update took place in November 27th of the same year. Currently, 60 participants are necessary for enrolment at a single site."

Answered by AI

How many people are engaged in the current research project?

"Affirmative. The information on clinicaltrials.gov confirms that this research study is still actively recruiting patients, having been initially posted on January 1st 2023 and last edited November 27th of the same year. 60 participants across a single medical facility are needed for enrollment."

Answered by AI

Are participants of a minimum age requirement being admitted to this trial?

"As per the requirements for joining this trial, potential enrollees must range between 6 and 10 years of age."

Answered by AI

What are the eligibility criteria for involvement in this research project?

"This clinical trial requires 60 participants, aged 6 to 10 years old with a diagnosed sleep disorder. Additionally, the child must have been living in their non-relative or kinship foster family for at least one month and experience behavioral sleep problems two times each week."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trauma-Informed Sleep Intervention for Children in Foster Care

Candice A Alfano 2023. "A Trauma-Informed Sleep Intervention for Children in Foster Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05646095.

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