N/A
Completed N=77
Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder
Source: ClinicalTrials.gov NCT03668873 ↗Enrolled (actual)
77
Serious AEs
2.9%
Results posted
Sep 2024
Primary outcomePrimary: Change From Baseline on MSPSQ-CSI — -2.09; -0.64; -3.31; -1.46 units on a scale — p=<0.001
Summary
Study Design: Ninety children with Autism Spectrum Disorder (ASD), between the ages of 2 to less than 7 years, and their parents will be recruited for this 10 week randomized clinical trial. Participants will be randomized to five individually delivered sessions of Sleep Parent Training (SPT) or five individually delivered sessions of Sleep Parent Education (SPE). Delivery of the programs will be via telehealth platform which also includes parent-child coaching in real-time. In addition to baseline, outcome measures will be collected at week 5 (midpoint of trial) and week 10 (endpoint of trial) as well as follow-up at week 16 to determine durability of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline on MSPSQ-CSI |
-2.09; -0.64; -3.31; -1.46 | <0.001 sig |
| PRIMARY Percentage of Treatment Responders at Week 10 Using Clinical Global Impression (CGI-I) Scale |
20; 12 | 0.037 sig |
| SECONDARY Change in ABC- Irritability From Baseline |
-0.13; -2.00; -2.32; -2.6 | 0.81 |
| SECONDARY Change in PSI From Baseline |
-6.23; -4.94; -9.88; -8.77 | 0.77 |
| SECONDARY PSOC Change From Baseline |
2.9; -1.81; 3.96; -0.68 | 0.003 sig |
Eligibility Criteria
Inclusion Criteria
- Both genders >2 and 5 on the CSI and a 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 16 weeks).
- Parental proficiency in spoken and written English language.
Exclusion Criteria
- Children with a serious medical condition or a known or suspected medical cause for sleep disturbances (e.g., nocturnal seizures, unresolved gastrointestinal problems such as reflux or constipation).
- Children with a psychiatric disorder or serious behavioral problems requiring immediate treatment.
- Children with known or suspected sleep apnea, restless legs, or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g. delayed or advanced sleep phase syndrome) based on history and all available information.
Data sourced from ClinicalTrials.gov (NCT03668873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.