断电试点研究:一种新颖的就寝时间操纵方案
断电:一项针对就寝时间控制以支持自闭症儿童睡眠的试点研究
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?
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Power Down pilot arm
All participants will engage in a 2-week pilot intervention trial with baseline and post-intervention testing. |
The Power Down is a bedtime manipulation protocol targeting elevated arousal level at bedtime due to a hypothesized effect of sensory over-responsivity (a common experience for autistic children). The Power Down incorporates sensory-based tools (gentle tactile pressure and auditory cues) to support nervous system regulation prior to attempting sleep onset. Participants (caregivers and their child) will be educated in the Power Down protocol and data collection methods for the 2 week intervention trial. Caregivers will lead a nightly gentle massage with guided relaxation script just prior to the child trying to fall asleep. The child will also wear a watch-like activity monitor (ActiGraph GT9x) for the 2 week period throughout the day and night to measure changes in sleep and activity patterns. Caregivers will complete daily diary questions in the morning and evening reporting their child's emotions and sleep timing. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recruitment rates of participants through the trial
大体时间: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 |
1 year
|
|
Retention rates of participants through the trial
大体时间: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. |
2 weeks
|
|
Caregiver reported acceptability
大体时间: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). |
Taken at end of 2-week intervention trial
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Treatment adherence
大体时间:During 2 week trial
|
As a secondary measure of feasibility, caregiver reported rates of treatment adherence will be measured. Caregivers will report completing the Power Down massage at least 10/14 nights during the 2 week intervention. |
During 2 week trial
|
|
Data collection rates- Questionnaires
大体时间:At baseline
|
We will measure completion rates of questionnaires as a secondary measure of feasibility. Benchmark: >75% of questionnaires will be completed |
At baseline
|
|
Data collection rates- Daily diaries
大体时间:2 weeks
|
We will measure completion rates of the number of daily diaries completed as a secondary measure of feasibility. Benchmark: >75% of daily diaries will be completed |
2 weeks
|
|
Data collection rates- Wearing the actigraphy watch
大体时间:2 weeks
|
We will measure the amount of days/nights children wore the actigraphy watch as a secondary measure of feasibility. Benchmarks: Children will tolerate wearing watch for at least 10/14 nights (6+ hours during their reported sleeping times) |
2 weeks
|
|
Credibility/Expectancy Questionnaire
大体时间:2 weeks
|
We will gather information about the caregiver's perceived credibility (questions 1-3, Set 1) and expectations (question 4 Set 1, questions 1-2 Set 2) related to the intervention at baseline and at the end of the intervention. Each question is rated on a 9-point scale, with 1 being "do not agree at all" and 9 being "strongly agree). Benchmark: At both baseline and post-intervention, caregivers will rate the intervention an average of 6 (on a 9 point scale) for both credibility and expectations, indicating more than somewhat confident. |
2 weeks
|
合作者和调查者
调查人员
- 首席研究员:Amy G Hartman, PhD、University of Pittsburgh
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- STUDY24010191
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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.
IPD 共享时间框架
Data will be available to share after publication of findings or 2 years after the end of the study, whichever comes first.
IPD 共享访问标准
Data will be shared with researchers within and outside of the University of Pittsburgh through email requests to the lead principal investigator. The University of Pittsburgh may require a data use agreement be developed and signed by both institutions.
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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