Powering Down: A Pilot Study of a Bedtime Manipulation to Support Sleep for Autistic Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Retention rates of participants through the trial
研究概览
简要总结
The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called "The Power Down" for autistic youth, ages 6-10. The main questions it aims to answer are:
- Is the Power Down feasible for caregivers to do each night?
- Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep?
详细描述
Interested participants will contact the research team and complete screening to determine eligibility (see Screener document). For eligible participants, the informed consent form will be sent and a consent call or video call will be scheduled. The study team will complete the consent process with eligible caregivers (on phone or via video call) and a consent form will be sent via DocuSign for the caregiver to sign.
Following the consent process, questionnaires (below) will be sent via REDCap to complete and a in-lab training meeting will be scheduled. During the in-lab training meeting, the PI (Hartman) will complete the bedtime manipulation training (details found in the Power Down Protocol document found in the Basic Study Information section of this IRB). After the education training, the caregiver(s) will be instructed in the "Power Down massage" and they will practice with their child in the lab and receive feedback on their delivery of the massage. The caregiver(s) and their child will also be given an activity monitor and instructed on the use and care of the device. The caregiver(s) will also review the morning and evening diaries to be completed throughout the study with a study team member.
Following the training session, the caregiver(s) and their child will complete the power down massage nightly, just prior to the time the child would start to try to fall asleep (e.g., after caregiver says "good night", when caregiver leaves the room), for two weeks. They will also complete a morning and evening diary entry, which will be sent virtually. At the end of the two weeks, the activity monitor will be returned to the study team. The participants will connect with the study team to complete an exit interview about their participation in the study and questionnaires about the treatment acceptability.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Child between the ages of 6 and 10 years old (at least 40%, no more than 60% female)
- Parent-reported autism diagnosis for child
- Parent-reported extended and problematic settling down delay
- Parent-reported sensory over-responsivity (a "yes" to at least 8 items in the sensory screening section of the checklist)
- Parent willing to participate in nightly routine during the 2 week study
- Located within the Pittsburgh area
排除标准
- Participants will be excluded if they do not understand English or are unable to travel to University of Pittsburgh Medical Center Western Psychiatric Hospital.
- Children who have trauma or other histories for whom physical touch is triggering (per caregiver report) will be excluded.
- If a child spends bedtime at a different caregiver's home for >50% of the nights and that caregiver is not willing to participate in this study, the child will be excluded from this study.
研究组 & 干预措施
Power Down pilot arm
All participants will engage in a 2-week pilot intervention trial with baseline and post-intervention testing.
干预措施: Power Down bedtime manipulation (Behavioral)
结局指标
主要结局
Retention rates of participants through the trial
时间窗: 2 weeks
We will use retention rates as one of our primary measure of feasibility of this protocol. Benchmarks include: Retention rates: \>80% of consented dyads will complete at least 10 nights of the Power Down during the 2 week intervention trial.
Caregiver reported acceptability
时间窗: Taken at end of 2-week intervention trial
During the exit interview, caregivers will be asked "Is this intervention an acceptable option for families who are experiencing bedtime difficulties" as a primary measure of acceptability. \>80% of enrolled participants who completed at least 4 days of the Power Down manipulation will report that the intervention is an acceptable option for families like theirs who are experiencing bedtime difficulties (question on post-intervention questions).
Recruitment rates of participants through the trial
时间窗: 1 year
We will use recruitment rates as one of our primary measure of feasibility of this protocol. Benchmark include: Recruitment rates: \>2 caregiver-child dyads enrolled per month
次要结局
- Data collection rates- Wearing the actigraphy watch(2 weeks)
- Data collection rates- Questionnaires(At baseline)
- Treatment adherence(During 2 week trial)
- Data collection rates- Daily diaries(2 weeks)
- Credibility/Expectancy Questionnaire(2 weeks)
研究者
Amy Hartman, PhD, OTR/L
Assistant Professor
University of Pittsburgh
研究点 (1)
标识符
- NCT 编号
- NCT06386029
- 其他研究编号
- STUDY24010191
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (29天前)
- 研究完成日期
- (2个月后)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
The full study protocol and informed consent forms will be shared with interested researchers upon request. Only aggregate and de-identified data collected throughout the clinical trial will be shared.