View Clinical Trial (Medical Research Study)
Treatment of Sleep Disturbances in Young Children With Autism
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15217 |
| Conditions: |
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Autism - Autism Spectrum Disorders |
| Purpose: |
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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.
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| Study Summary: |
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Autism Spectrum Disorders (Autistic Disorder, Pervasive Developmental Disorder, Asperger
Disorder) are severe developmental disorders of early childhood onset affecting as many as 1
in 150 children (Center for Disease Control & Prevention, 2007). They characterized by
deficits in social interaction and communication, as well as repetitive behavior and
restricted interests (American Psychiatric Association, 2000). Given the severity and the
prevalence, autism is a significant public health issue. Recent years have seen both an
increase in the prevalence of autism and an improved ability to diagnose the disorder much
earlier (Fombonne, 2003). It is during the child's early years when it is generally agreed
that intensive interventions are most likely to improve long term prognosis (National
Research Council, 2001). While not a core feature of autism, it is widely accepted that a
large percentage children with autism spectrum disorders (autism) present with significant
sleep issues (Honomichl, Goodlin-Jones, Burnham, Gaylor & Anders, 2002; Johnson, 1996; Wiggs
& Stores, 2004). Sleep problems in typically developing children are known to adversely
impact daytime functioning, learning acquisition, as well as parenting and family
functioning (Dahl, 1996; Ebert & Drake, 2004; Sadeh, Gruber, & Raviv; 2002; Sadeh, Raviv, &
Gruber, 2000). For young children with autism whose development is already compromised by a
range of deficits, the detrimental impact of sleep disturbances may be even more
significant. However, the impact of sleep disturbances on optimal performance in behavioral
and education interventions have not been systematically explored.
This study will conduct a randomized clinical trial to evaluate the efficacy of a behavioral
parent training program in the amelioration of sleep disturbances in young children with
autism. This work will be used to examine the feasibility, acceptability and efficacy of a
behavior training program for sleep disturbance in children with autism. It represents a low
cost and rapid clinical approach to the problem in this younger age group.
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| Criteria: |
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Inclusion Criteria:
- Diagnosed with an autism spectrum disorder
- Presence of sleep disturbance
Exclusion Criteria:
- Medical etiology of sleep disturbance
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| NCT ID: |
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NCT01322022 |
| Primary Contact: |
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Principal Investigator
Cynthia R Johnson, PhD
U of Pittsburgh
Emily Foldes, MS
Phone: 4126925840
Email: emily.foldes@chp.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Pittsburgh, Pennsylvania 15217
United States
Emily Foldes, MS
Phone: 412-692-5840
Email: emily.foldes@chp.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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