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Behavioral Intervention

Power Down pilot arm for Autism Spectrum Disorder

N/A

Waitlist Available

Led By Amy G Hartman, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child between the ages of 6 and 10 years old (at least 40%, no more than 60% female)

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial aims to see if a new bedtime routine called "The Power Down" is possible and liked by families of autistic children aged 6-10 to help them fall asleep easier.

Who is the study for?

This trial is for autistic children aged 6-10 who have trouble settling down to sleep. It's designed to see if caregivers can use the 'Power Down' method every night and if families find it helpful.Check my eligibility

What is being tested?

The study tests a new bedtime routine called 'Power Down.' Researchers want to know if it's easy for parents to follow and whether they think it works well for their kids with sleep issues.See study design

What are the potential side effects?

Since this is a behavioral intervention involving a bedtime routine, there are no direct medical side effects. However, changes in nighttime habits could temporarily affect the child's or family’s sleep patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 6 and 10 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Caregiver reported acceptability

Recruitment rates of participants through the trial

Retention rates of participants through the trial

Secondary outcome measures

Credibility/Expectancy Questionnaire

Data collection rates- Daily diaries

Data collection rates- Questionnaires

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Power Down pilot armExperimental Treatment1 Intervention

All participants will engage in a 2-week pilot intervention trial with baseline and post-intervention testing.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,726 Previous Clinical Trials

16,305,733 Total Patients Enrolled

16 Trials studying Autism Spectrum Disorder

10,454 Patients Enrolled for Autism Spectrum Disorder

Amy G Hartman, PhDPrincipal InvestigatorUniversity of Pittsburgh

Frequently Asked Questions

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

Which individuals meet the criteria to be considered as potential candidates for enrollment in this trial?

"To be eligible for enrollment, candidates must possess autism spectrum disorder and fall between 6 to 10 years of age. The study aims to recruit approximately 10 participants."

Answered by AI

Are individuals older than 35 years of age eligible to participate in this study?

"Individuals aged between 6 and 10 years are eligible for participation based on the specified age parameters in the inclusion criteria of this research."

Answered by AI

Are patients currently being actively recruited for participation in this trial?

"As per information on clinicaltrials.gov, the current status of this medical research endeavor is not in recruitment phase. The trial's initial posting date was recorded as May 1st, 2024 and its most recent update occurred on April 22nd, 2024. Despite this specific study no longer seeking participants, it is noteworthy that there are a total of 215 alternative studies currently open for enrollment."

Answered by AI

What is the main objective of this clinical trial?

"The primary aim of this 2-week trial is to assess participant recruitment rates. Secondary objectives include evaluating treatment adherence, as indicated by caregiver reports of consistently administering the Power Down massage for a minimum of 10 out of 14 nights during the intervention period. Additionally, data collection will encompass tracking completion rates of daily diaries with a target benchmark set at over 75% completion. Furthermore, compliance with wearing the actigraphy watch will be monitored, aiming for children to wear it for no less than 10 out of 14 nights and maintain its usage for at least six hours during their reported sleeping periods."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol

Amy Hartman 2024. "The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06386029.

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