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Treatment of Sleep Disturbances in Young Children With Autism

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ClinicalTrials.gov Identifier: NCT01322022
Recruitment Status : Completed
First Posted : March 24, 2011
Results First Posted : February 2, 2015
Last Update Posted : August 25, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pittsburgh

March 22, 2011
March 24, 2011
December 4, 2014
February 2, 2015
August 25, 2015
December 2009
November 2012   (Final data collection date for primary outcome measure)
  • Modified Simond & Parraga Sleep Questionnaire (MSPSQ) - Composite Sleep Index [ Time Frame: Baseline, Week 4, and Week 8 ]
    The MSPSQ used by Wiggs and colleagues (Wiggs & Stores, 1996 ; Wiggs & Stores, 1999 : Wiggs & Stores, 2004) was used to assess the child's sleep quality. It was completed by the primary caregiver for both groups at baseline and at weeks 4 and 8. Using Wiggs & Stores earlier-described conventions for determining the Composite Sleep Index (CSI) score, the CSI was calculated by assigning a score to the frequency of the targeted sleep problems: bedtime resistance, night awakening, early awakening, and sleeping in places other than bed. In addition, scores were assigned for the duration of sleep latency and night awakenings. The total CSI score ranged from 0 to 12, with higher scores indicating more severe bedtime and sleep patterns.
  • Actigraphy - Sleep Efficiency [ Time Frame: Baseline, Week 4, Week 8 ]
    Measure of sleep efficiency defined as the percentage of time sleeping while in bed with lights off
  • Actigraphy - Sleep Latency [ Time Frame: Baseline, Week 4, Week 8 ]
    Measure of sleep latency defined by the time from lights off to sleep onset.
Modified Simond & Parraga Sleep Questionnaire (MSPSQ) [ Time Frame: Baseline, Week 4, and Week 8 ]
The MSPSQ used by Wiggs and colleagues (Wiggs & Stores, 1996 ; Wiggs & Stores, 1999 : Wiggs & Stores, 2004) will be used. It will be completed by the primary caregiver for both groups. The questionnaire consists of two parts. Part 1 includes items related to the quantity and quality of sleep, while Part 2 asks more detailed questions specific to sleep disorders. A composite sleep index score is used by assigning a score to the frequency of sleep problems targeted: bedtime resistance, night waking, early morning waking and sleeping in places other than bed.
Complete list of historical versions of study NCT01322022 on ClinicalTrials.gov Archive Site
Actigraphy - Total Sleep Time [ Time Frame: Baseline, Week 4, Week 8 ]
Measure of total time spent asleep using Motionlogger model actigraph by Ambulatory Monitoring, Inc. (www.ambulatory-monitoring.com) and algorithms in associated software.
Actigraphy [ Time Frame: After the Home Visit, After the Week 4 Assessment, After the Week 8 Assessment ]
Each child will wear an actigraph for five consecutive weeknights. An actigraph is a small watch-like device that collects activity data. The processor samples physical motion and translates it to numerical digital data. It summarizes and stores the frequency of motions into epochs of specified time duration. It is a reliable method of objective data collection for sleep-wake patterns including timing, continuity, and duration of sleep. We will determine when the child is down for sleep (lights off after any bedtime routine) from a sleep diary that the primary caregiver will complete.
Not Provided
Not Provided
 
Treatment of Sleep Disturbances in Young Children With Autism
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 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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Autism
  • Autism Spectrum Disorders
  • Behavioral: ParentTraining
    5 sessions of individual parent training
    Other Names:
    • Behavioral intervention
    • Psychoeducational intervention
  • Other: Parent Education
    Parent Education to control for time and attention
    Other Name: Control
  • Experimental: Parent Training
    Behavioral Intervention
    Intervention: Behavioral: ParentTraining
  • Active Comparator: Parent Education
    5 Sessions of individual parent education
    Intervention: Other: Parent Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Same as current
January 2013
November 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with an autism spectrum disorder
  • Presence of sleep disturbance

Exclusion Criteria:

  • Medical etiology of sleep disturbance
Sexes Eligible for Study: All
24 Months to 72 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01322022
PRO09070340
R34MH082882 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Pittsburgh
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Cynthia R Johnson, PhD U of Pittsburgh
University of Pittsburgh
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP