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Sleep Parent Training for Autism Spectrum Disorder

N/A

Waitlist Available

Led By Cynthia Johnson, PhD

Research Sponsored by The Cleveland Clinic

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 baseline and 10 weeks

Awards & highlights

Study Summary

This trial is testing a sleep training program for kids with ASD aged 2-7 and their parents. The training will be delivered via telehealth 5 times, with outcome measures at baseline, 5 weeks, 10 weeks, and 16 weeks.

Eligible Conditions

Autism Spectrum Disorder
Sleep Disorder
Autism

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 10 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Improvement in Sleep Disturbances

Secondary outcome measures

Parental Quality of Life: PSOC

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sleep Parent TrainingExperimental Treatment1 Intervention

The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-weeks. In addition to the five sessions, there are three home visits conducted via Express Care Online (HIPAA compliant video-chat). After Session A, session order may be adjusted to address child-specific problems. One-on-one delivery of SPT permits flexibility for child-specific problems within the program.

Group II: Sleep Parent EducationActive Control1 Intervention

SPE consists of five 60-90 minute sessions, delivered individually over 10 weeks. SPE provides useful information to families of young children with ASD and sleep problems. Session A is designed to develop rapport. The sleep hygiene session (Session B) has been modeled from the RUBI manual. The other sessions include a systematic presentation on several relevant topics. An example of a SPE session is provided in the Intervention section. This condition is intended to parallel what would be offered in typical care, but by telehealth, where a parent might be educated about ASD as well as attend an outpatient appointment at a sleep clinic.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,026 Previous Clinical Trials

1,365,986 Total Patients Enrolled

4 Trials studying Autism Spectrum Disorder

628 Patients Enrolled for Autism Spectrum Disorder

United States Department of DefenseFED

861 Previous Clinical Trials

227,104 Total Patients Enrolled

18 Trials studying Autism Spectrum Disorder

1,650 Patients Enrolled for Autism Spectrum Disorder

Cynthia Johnson, PhDPrincipal Investigator - The Cleveland Clinic

Morton Plant Hospital

Umdnj-Robt W Johnson Medical Sch (Medical School)

Cleveland Clinic Fndn (Residency)

1 Previous Clinical Trials

180 Total Patients Enrolled

Frequently Asked Questions

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

Are participants aged under 60 years considered viable for this medical experiment?

"This particular clinical trial is searching for participants aged 2 to 7. In addition, there are 256 trials available to minors and 137 studies recruiting seniors over 65 years old."

Answered by AI

Are there any available vacancies for individuals to join the experiment?

"According to clinicaltrials.gov, this trial has closed recruitment after being first posted on November 1st 2018 and last edited on August 30th 2022. Nevertheless, there are presently 400 other medical studies actively seeking participants."

Answered by AI

Is it feasible for me to enroll in this research?

"The trial is targeting 90 participants with autism spectrum disorder between the ages of 2 and 7. To be eligible, they must have a score greater than 5 on the CSI scale along with a Clinical Global Impression Severity (CGI-S) rating at least moderate in intensity. Furthermore, all candidates should not have changed their medications or supplements for 6 weeks prior to application and remain unchanged throughout the duration of 16 weeks. Both genders are welcome to apply."

Answered by AI

Recent research and studies

Sleep MedicineJournal

Behavioral Parent Training to Address Sleep Disturbances in Young Children with Autism Spectrum Disorder: A Pilot Trial

Johnson, Cynthia R., Kylan S. Turner, Emily Foldes, Maria M. Brooks, Rebecca Kronk, and Luci Wiggs. 2013. “Behavioral Parent Training to Address Sleep Disturbances in Young Children with Autism Spectrum Disorder: A Pilot Trial”. Sleep Medicine. Elsevier BV. doi:10.1016/j.sleep.2013.05.013.

clinicaltrials.govStudy

Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder

Cynthia Johnson 2018. "Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03668873.