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Can a sleep program help exhausted parents of kids with autism?

NCT ID NCT05373537

Symptom relief Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a home-based, tailored sleep therapy (CBT-I) to a web-based version for 80 caregivers who have insomnia while caring for a child with autism. The goal is to see which approach is more acceptable and feasible for improving sleep and reducing caregiver burden. Participants will track their sleep and complete surveys over the study period.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for Caregiver with a child with ASD: * Caregiver age 18 years or older * Diagnosis of Insomnia * Parental/guardian will give permission (informed consent) for child * Telephone and web Access * Stable medical and behavioral conditions, with no change in health status in the past three months * Commitment to maintaining stable medication doses and keeping medication consistent Inclusion Criteria for Children with ASD: * Children age 3 to 17 years and one of their parents * Diagnosis of Autism Spectrum Disorders, confirmed with Autism Diagnostic Observation Schedule and/or DSM-IV criteria. * Diagnosis of Behavioral Insomnia or Insomnia due to ASD (Insomnia due to internal * Parental/guardian permission (informed consent) and if appropriate, child assent. * Telephone and web Access * Stable medical and behavioral conditions, with no change in health status in the past * Commitment to maintaining stable medication doses and keeping child's sleep medication consistent Key exclusion criteria for Caregiver and child with ASD: * Insomnia due to co-occurring medical conditions and/ or sleep disorders such as obstructive sleep apnea (OSA), narcolepsy, restless leg syndrome, severe reflux, nocturnal asthma * Unstable co-occurring medical conditions such as epilepsy or other neurological disorders, sickle cell anemia, diabetes or severe eczema * Significant hearing or vision loss * Known genetic disorders such as Fragile X, 22ql 1.2 Deletion Syndrome, Rett Disorder, Down Syndrome. * Subjects who, in the opinion of the Investigator, may be non¬ compliant with study schedules or procedures.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder Caregiver Burden insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder Caregiver burden Insomnia chronic

Contacts and locations

Locations

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19041, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.