Clinical trial for Insomnia
Official title Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children
ClinicalTrials.gov ID: NCT07435740
What this study is testing
- What it's testing
- The study wants to see if a structured parent‑led behavioral program (Sleep Parent Treatment) works better than basic sleep education (Sleep Parent Education) for improving sleep in autistic children.
- Who it's for
- Children with autism, ages 3 to 7 years and 11 months, who have trouble sleeping.
- What's involved
- Parents will receive either the Sleep Parent Treatment or Sleep Parent Education program and follow the assigned plan for 10 weeks, with guidance provided through telehealth sessions.
- Time commitment
- The trial lasts about 10 weeks and includes regular telehealth visits during that time.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 7
You may be able to join if
- Age \>3 to 7 years 11 months
- Clinical diagnosis of ASD supported by the Autism Diagnostic Interview Revised (ADI-R)
- Score of 30 or more on the Parent-Rated Insomnia Scale - ASD (PAIRS) and the Clinical Global Impression Severity (CGI-S) score of Moderate or greater...
- Medication and supplement free or on stable medication or supplements (no changes in the past 6 weeks and no planned changes for 10 weeks of the...
- Parental proficiency in spoken and written English language. Study materials and many of the study measures are only available in English
You likely can't join if
- Children with a history of serious medical condition or known medical cause insomnia (e.g., nocturnal seizures, unresolved gastrointestinal problems...
- Children with a psychiatric disorder or serious behavioral problem requiring a different treatment
- Children with known sleep apnea, restless leg syndrome, or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed...
- Children of non-English language speaking caregivers will be excluded because study intervention materials and many of the study measures are only...
The study team makes the final eligibility decision.
Where it is enrolling
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 7 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cleveland, Ohio, United States; Columbus, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.