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Behavioral Intervention

Sleep Restriction Therapy for Autism and Sleep Disorders

N/A

Waitlist Available

Led By Emma K Baker, MPsych(Clin), PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Diagnosed with sleep disturbances based on clinical interview and Sleep Disturbance Scale for Children score > 38

Be younger than 18 years old

Must not have

Children with active seizures or epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 1, week 2, during 4-week follow-up period, end of treatment (approximately week 10)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a type of therapy called sleep restriction therapy can help children with autism spectrum disorder (ASD) who have sleep problems. The therapy will be given through a secure online platform

Who is the study for?

This trial is for children with Autism Spectrum Disorder (ASD) who are experiencing sleep problems. Parents will be trained to deliver the therapy via a secure telemedicine platform.

What is being tested?

The study is testing Sleep Restriction Therapy (SRT) to see if it's acceptable, tolerable, and effective for improving sleep in children with ASD.

What are the potential side effects?

Since this is a behavioral therapy involving sleep scheduling, side effects may include initial increased tiredness or changes in mood or behavior due to changes in the child's sleep patterns.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with sleep problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child currently has seizures or epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 1, week 2, during 4-week follow-up period, end of treatment (approximately week 10)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 1, week 2, during 4-week follow-up period, end of treatment (approximately week 10)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 2, during 4-week follow-up period, end of treatment (approximately week 10) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Sleep Restriction Therapy

Feasibility of Sleep Restriction Therapy

Tolerability of Sleep Restriction Therapy

Secondary study objectives

Change from baseline on the Sleep Disturbance Scale for Children

Change in Wake After Sleep Onset (Actigraphy)

Change in sleep efficiency (Actigraphy)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sleep Restriction TherapyExperimental Treatment1 Intervention

Participants attend telehealth sessions once per week for three weeks and implement sleep restriction therapy in between sessions and for 4 weeks during a follow-up period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sleep Restriction Therapy

2014

N/A

~210

0 / 2Eligibility criteria met