Implementing Evidence-based Behavioral Sleep Intervention in Urban Primary Care: Aim 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Retention Rate (Intervention Feasibility)
研究概览
简要总结
Investigators will enroll up to 120 parent-child dyads from Children's Hospital of Philadelphia (CHOP) urban primary care clinics. The primary objective of this randomized clinical trial is to determine the whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. The investigators will also examine the direction and magnitude in any change in child sleep and child behavior.
详细描述
Behavioral sleep problems such as insomnia and insufficient sleep are common in toddlers and preschoolers and disproportionately impact lower socioeconomic status (SES) children. Despite a robust evidence base, behavioral sleep interventions are rarely tested with lower-SES children or in primary care, an accessible service delivery setting. The primary objective of this study is to determine whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. The investigators will also examine the direction and magnitude of change in child sleep and behavior from pre-intervention to post-intervention and follow-up. This is a randomized controlled trial of the Sleep Well! program with pre-intervention, post-intervention, and follow-up assessments. Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites.
Sleep Well! is a brief, behavioral sleep intervention for toddlers and preschoolers who have a caregiver-reported behavioral sleep problem or who are not getting enough sleep. The intervention includes evidence-based behavioral sleep approaches and strategies to engage and empower families. The primary outcomes for this pilot trial are feasibility (number of caregivers recruited, engaged, and retained in intervention; participant intervention attendance rate) and caregiver acceptability, assessed via a questionnaire and qualitative post-intervention interview. Secondary outcomes are the direction and magnitude in any change in child sleep. Tertiary outcomes are the direction and magnitude in change in child behavior. Assessments occur at pre-intervention, post-intervention, and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research assistants conducting outcome assessments will be blinded to study condition.
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parental/guardian permission (informed consent)
- •Caregiver participant is the parent or legal guardian of the child subject
- •Caregiver/legal guardian is greater than or equal to 18 years of age.
- •Child between the ages of 1 and 5 years.
- •Presence of caregiver-reported child sleep problem determined by a Brief Child Sleep Questionnaire item included in an eligibility screening questionnaire or child meets American Academy of Sleep Medicine diagnostic criteria for either pediatric insomnia or insufficient sleep, assessed through an eligibility screening questionnaire.
- •English-speaking.
排除标准
- •Caregiver is not parent or legal guardian of child participant.
- •Presence of a child neurodevelopmental (e.g., autism spectrum disorder; Trisomy 21) or chronic medical (e.g., sickle cell disease, cancer) concern in which the disorder or treatment of the disorder impact sleep.
- •Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
研究组 & 干预措施
Sleep Well! Intervention
Participants in this condition will begin the Sleep Well! intervention after initiating baseline, daily diary, and actigraph procedures. Sleep Well! will be provided over approximately 6-8 weeks and will include 3 sessions. Intervention sessions will typically last about an hour, but session length may vary.
干预措施: Sleep Well! (Behavioral)
Enhanced Usual Care
The enhanced usual care condition will occur between 6 and 8 weeks. At randomization to this condition, participants will be provided with an evidence-based sleep guidelines for young children from the CHOP Parent Family Education manual. Participants in this condition will also be able to consult with their primary care physician for management of child sleep. Consistent with usual care in the CHOP system, the primary care physician may manage the sleep concern or choose to make a referral to the CHOP sleep center or to other behavioral health services internal or external to the CHOP system. Of note, the CHOP Parent Family Education handouts provide contact information for the CHOP Sleep Center and direct readers to follow-up with their primary care provider for further guidance.
干预措施: Sleep education (Behavioral)
结局指标
主要结局
Retention Rate (Intervention Feasibility)
时间窗: Study duration (up to 24 weeks)
The study team will track the number of caregiver-child dyad participants assigned to the Sleep Well! condition who complete the intervention as a measure of retention, or intervention feasibility. The retention rate reported is for those who completed all sessions and phone calls for the Sleep Well! intervention.
Family Engagement (Sessions)
时间窗: Study duration (up to 24 weeks)
For families randomized to the intervention condition, study interventionists will rate family engagement during telehealth sessions using a one-item 5-point Likert scale ranging from 1 (not engaged) to 5 (very good engagement), with higher scores representing better engagement. The outcome reported is the average rating of telehealth session engagement across sessions 1, 2, and 3.
Assessment Process (Study Feasibility)
时间窗: Study duration (up to 24 weeks)
The study team will keep records of the number of planned assessments that are completed (i.e., the entire assessment was completed) as a measure of study feasibility.
Family Engagement (Telephone Calls)
时间窗: Study duration (up to 24 weeks)
For families randomized to the intervention condition, study interventionists will rate family engagement during telephone calls using a one-item 5-point Likert scale ranging from 1 (not engaged) to 5 (very good engagement), with higher scores representing better engagement. The outcome reported is the average rating of telehealth session engagement across all completed telephone calls.
Treatment Acceptability
时间窗: Time 2 (an average of 9 weeks post-baseline)
Caregivers will complete the Treatment Evaluation Inventory-Short Form, a widely used measure of treatment acceptability that has been adapted for the purposes of the Sleep Well! intervention. For this reported outcome, caregivers responded to the statement "I found these strategies to be an acceptable way of dealing with my child's sleep" on a 5-point Likert scale ranging from 1 "strongly disagree" to 5 "strongly agree," with higher scores reflecting stronger acceptability.
Treatment Acceptability: Cultural Humility
时间窗: Time 2 (an average of 9 weeks post-baseline)
Caregivers will complete the Multicultural Therapy Competency Inventory- Client Version, adapted for the current study, to assess participants' perceptions of the Sleep Well! therapist's cultural humility during the intervention. Caregivers in the intervention condition responded to the statement "When we discussed my child's sleep, my Sleep Well! therapist was accepting of my family's values and beliefs," on a 5-point Likert scale ranging from 1 "strongly disagree" to 5 "strongly agree." Higher ratings indicate greater perceived cultural humility.
次要结局
- Severity of Child Sleep Problems(Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline))
- Child Sleep Problems: Bedtime Difficulties(Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline))
- Child Sleep Patterns: Sleep Onset Latency(Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline))
- Child Sleep Patterns: Number of Wakings Per Night(Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline))
- Child Sleep Patterns: Duration of Wakings Per Night(Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline))
- Child Sleep Patterns: Nighttime Sleep Duration(Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline))
- Child Sleep Patterns: Total 24-hour Sleep Duration(Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline))
- Child Behavior Problems: Externalizing Problems(Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline))
- Child Behavior Problems: Internalizing Problems(Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline))
- Child Sleep Patterns: Actigraphy Derived Nighttime Sleep Duration(7 days at Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline))