130 Participants NeededMy employer runs this trial

Parent-Mediated Telehealth Intervention for Autism and Insomnia

Recruiting at 2 trial locations
LL
CJ
Overseen ByCynthia Johnson, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of two parent-led programs in improving sleep for young autistic children with insomnia. The Sleep Parent Training (SPT) program involves structured sessions with parents, while the Sleep Parent Education (SPE) program provides educational support. The trial aims to determine which approach better manages sleep issues. Families with children diagnosed with autism who experience moderate or greater insomnia, and whose parents speak English, may qualify to participate. As an unphased trial, this study allows families to contribute to valuable research that could enhance sleep interventions for autistic children.

Will I have to stop taking my current medications?

You can continue taking your current medications as long as they have been stable for at least 6 weeks and you don't plan to change them during the 10-week trial.

What prior data suggests that these interventions are safe for autistic children with insomnia?

Research shows that the Sleep Parent Treatment (SPT) is safe and effective for young autistic children. Studies have found that using SPT through telehealth addresses sleep problems without causing major side effects. For example, one study showed that SPT improved bedtime routines and reduced sleep issues in autistic children compared to another treatment group. Another study found that children fell asleep faster after just a few sessions of parent-led sleep education.

Overall, the evidence suggests that parents can trust the safety of this treatment. No reports of serious problems related to SPT have emerged, making it a promising option for helping autistic children with sleep difficulties.12345

Why are researchers excited about this trial?

Researchers are excited about the Sleep Parent Treatment (SPT) and Sleep Parent Education (SPE) because they offer a unique, parent-mediated telehealth approach to managing autism-related insomnia. Unlike traditional treatments that may involve medication or in-person therapy, these interventions empower parents through virtual sessions, providing them with tools and strategies to help their children sleep better. This approach is particularly promising because it allows for flexible, accessible support that can be tailored to each family's needs, potentially leading to more sustainable and long-lasting improvements in sleep.

What evidence suggests that this trial's treatments could be effective for autism and insomnia?

This trial will compare two approaches: Sleep Parent Treatment (SPT) and Sleep Parent Education (SPE). Studies have shown that teaching parents about sleep can help autistic children who have trouble sleeping. In the Sleep Parent Treatment (SPT) arm of this trial, research indicates that when parents learn how to help their children sleep, the children sleep better and experience fewer insomnia issues. Using telehealth, or online methods, has also proven effective, leading to even greater sleep improvements. In the Sleep Parent Education (SPE) arm, similar studies show that when parents receive education about sleep, their children fall asleep faster. Both methods have shown promise in improving sleep for children with autism.16789

Who Is on the Research Team?

LL

Luc Lecavalier, PhD

Principal Investigator

Ohio State University

CR

Cynthia R Johnson

Principal Investigator

Cleveland Clinic Center for Autism

LS

Lawrence Scahill, MSN, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for children aged 3 to just under 8 years old who have autism and significant sleep problems. They must be on stable medications (if any) and have parents who can read and speak English.

Inclusion Criteria

I am between 3 and 7 years old.
* Clinical diagnosis of ASD supported by the Autism Diagnostic Interview Revised (ADI-R)
* Score of \>30 on the Parent-Rated Insomnia Scale - ASD (PAIRS) and the Clinical Global Impression Severity (CGI-S) score of Moderate or greater (\>4 score)
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Sleep Parent Treatment (SPT) or Sleep Parent Education (SPE) for 10 weeks

10 weeks
5 sessions (telehealth)

Follow-up

Participants are monitored for changes in insomnia severity and overall improvement

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sleep Parent Education (SPE)
  • Sleep Parent Training (SPT)

Trial Overview

The study compares two parent-led programs delivered online over 10 weeks: Sleep Parent Training (SPT), which teaches behavioral strategies for better sleep, versus Sleep Parent Education (SPE), which provides general information about sleep.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Sleep Parent Treatment (SPT)Experimental Treatment1 Intervention
Group II: Sleep Parent Education (SPE)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

The Cleveland Clinic

Collaborator

Trials
1,072
Recruited
1,377,000+

Ohio State University

Collaborator

Trials
891
Recruited
2,659,000+

Citations

Parent-Based Sleep Education for Children with Autism ... - PMC

Parent-based sleep education, delivered in relatively few sessions, was associated with improved sleep onset delay in children with ASD.

Digital and telehealth behavioral sleep interventions for ...

Behavioral interventions are first-line treatments for pediatric insomnia and have shown effectiveness in ASD, with evidence of improvements in total sleep time ...

Parent-Based Sleep Education Workshops in Autism - PMC

To determine if parents can successfully teach their children with autism spectrum disorders to become better sleepers, we piloted small group parent ...

Sleep disturbances in autistic children and adolescents

Recent studies have demonstrated the effectiveness of behavioral treatments, including sleep education programs for parents of autistic children ...

Autism Spectrum Disorder and Sleep

Parental education and behavioral interventions are effective in ameliorating the insomnia experienced by children with ASD. There is growing evidence that ...

Telehealth parent training for sleep disturbances in young ...

Telehealth delivery of Sleep Parent Training (SPT) improved bedtime and sleep disturbances in a sample of young autistic children compared to an active control.

Sleep in Children with Autism Spectrum Disorder - PMC - NIH

The purposes of this paper are to provide an overview of the state of the science of sleep in children with autism spectrum disorder (ASD).

Interventions | Center for Sleep in Autism Spectrum Disorder

Preliminary evidence has suggested that anti-oxidants such as L-carnosine [27] and co-enzyme Q [28] can improve sleep in children on the autism spectrum. · The ...

Establishing OT's Role in Addressing Sleep Disturbances for ...

This rapid systematic review examined the relationship between various interventions and sleep measures for autistic children and adolescents.