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NCT01322022 · ClinicalTrials.gov registry record · NA
Treatment of Sleep Disturbances in Young Children With Autism
A NA study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT01322022 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 40 participants.
The verdict
NCT01322022, a NA study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study will compare the efficacy of a behavioral parent training program (PT) aimed specifically at common sleep disturbances compared to parent education (PE) program focusing on general issues related to autism. In a sample of 40 well characterized young children who meet criteria for an autism spectrum disorder (24-72 months), the investigators will test whether the five session PT program is superior to the PE program in decreasing sleep disturbances. The primary aim of this study is to evaluate the efficacy and feasibility of a PT program for sleep disturbance in young children with autism compared to PE. To this end, there are two hypothesis: * Hypothesis 1: After the end of treatment, PT will be significantly more effective than PE in improving parent reports of a) bedtime struggles and resistance; b) sleep latency; c) night wakings; d) morning wakings; and / or e) sleep association problems as measured by the composite sleep index score from the modified Simonds and Parraga Sleep Questionnaire (MSPSQ; Simond \& Parraga, 1982; Wiggs \& Stores, 1998). * Hypothesis 2: At the end of treatment, children in the PT group (n=20) will display significantly improved total sleep period as measured by actigraphy in comparison to children in the PE group (n=20). The secondary aim of this study is to evaluate the impact of participating in PT on child's daytime behavior and functioning and parenting stress compared to PE. To measure this aim, there are 4 exploratory hypothesis: * Exploratory Hypothesis 1: Lower Irritability subscales scores will be reported on both parent and teacher / therapist completed Aberrant Behavior Checklist (ABC) for the PT group than the PE group at 4 weeks and 8 weeks * Exploratory Hypothesis 2: Lower Child Behavior Checklist (CBCL; parent completed) and Caregiver-Teacher Report Form (C-TRF; teacher completed) scores will be reported for the PT group than the PE group at 4 weeks and 8 weeks. * Exploratory Hypothesis 3: The PT group wi
Interventions
- OTHER Parent Education
- BEHAVIORAL ParentTraining
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-12 |
| Est. Completion | 2013-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01322022
The ClinicalTrials.gov registry entry for NCT01322022 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Parent Education is the first listed.
NCT01322022 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01322022 about?
NCT01322022 is a clinical study titled "Treatment of Sleep Disturbances in Young Children With Autism". This study will compare the efficacy of a behavioral parent training program (PT) aimed specifically at common sleep disturbances compared to parent education (PE) program focusing on general issues related to autism. In a sample of 40 well characterized young children who meet criteria for an autis...
What is the current status of trial NCT01322022?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2009-12. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01322022?
The interventions under investigation include: Parent Education (OTHER), ParentTraining (BEHAVIORAL).
Who is sponsoring clinical trial NCT01322022?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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