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More info
You can access this
clinical trial
if you have
Autism or Autism Spectrum Disorders
and you are
between 24 and 72
years old
-
The phase for this study is not defined.
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The purpose

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 will have higher scores on the Vineland Adaptive Behavior Scales: 2nd Edition (VABS-II) at 4 weeks and 8 weeks compared to PE group. - Exploratory Hypothesis 4: Parents receiving PT will report significantly lower scores on the Parenting Stress Index (PSI) at 4 weeks and 8 weeks compared to parents receiving PE.

Provided treatments

  • Behavioral: ParentTraining
  • Other: Parent Education

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01322022. The sponsor of the trial is University of Pittsburgh and it is looking for 40 volunteers for the current phase.
Official trial title:
Treatment of Sleep Disturbances in Young Children With Autism