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Treatment of Sleep Disturbances in Young Children With Autism

Primary Purpose

Autism, Autism Spectrum Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ParentTraining
Parent Education
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism, Autism Spectrum Disorders, Sleep Problems, Sleep Disturbances, Interventions

Eligibility Criteria

24 Months - 72 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Medical etiology of sleep disturbance

Sites / Locations

  • Children's Hospital of Pittsburgh Autism Cetner

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Parent Training

Parent Education

Arm Description

Behavioral Intervention

5 Sessions of individual parent education

Outcomes

Primary Outcome Measures

Modified Simond & Parraga Sleep Questionnaire (MSPSQ) - Composite Sleep Index
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
Measure of sleep efficiency defined as the percentage of time sleeping while in bed with lights off
Actigraphy - Sleep Latency
Measure of sleep latency defined by the time from lights off to sleep onset.

Secondary Outcome Measures

Actigraphy - Total Sleep Time
Measure of total time spent asleep using Motionlogger model actigraph by Ambulatory Monitoring, Inc. (www.ambulatory-monitoring.com) and algorithms in associated software.

Full Information

First Posted
March 22, 2011
Last Updated
August 11, 2015
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01322022
Brief Title
Treatment of Sleep Disturbances in Young Children With Autism
Official Title
Treatment of Sleep Disturbances in Young Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum Disorders
Keywords
Autism, Autism Spectrum Disorders, Sleep Problems, Sleep Disturbances, Interventions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent Training
Arm Type
Experimental
Arm Description
Behavioral Intervention
Arm Title
Parent Education
Arm Type
Active Comparator
Arm Description
5 Sessions of individual parent education
Intervention Type
Behavioral
Intervention Name(s)
ParentTraining
Other Intervention Name(s)
Behavioral intervention, Psychoeducational intervention
Intervention Description
5 sessions of individual parent training
Intervention Type
Other
Intervention Name(s)
Parent Education
Other Intervention Name(s)
Control
Intervention Description
Parent Education to control for time and attention
Primary Outcome Measure Information:
Title
Modified Simond & Parraga Sleep Questionnaire (MSPSQ) - Composite Sleep Index
Description
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.
Time Frame
Baseline, Week 4, and Week 8
Title
Actigraphy - Sleep Efficiency
Description
Measure of sleep efficiency defined as the percentage of time sleeping while in bed with lights off
Time Frame
Baseline, Week 4, Week 8
Title
Actigraphy - Sleep Latency
Description
Measure of sleep latency defined by the time from lights off to sleep onset.
Time Frame
Baseline, Week 4, Week 8
Secondary Outcome Measure Information:
Title
Actigraphy - Total Sleep Time
Description
Measure of total time spent asleep using Motionlogger model actigraph by Ambulatory Monitoring, Inc. (www.ambulatory-monitoring.com) and algorithms in associated software.
Time Frame
Baseline, Week 4, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
72 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with an autism spectrum disorder Presence of sleep disturbance Exclusion Criteria: Medical etiology of sleep disturbance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia R Johnson, PhD
Organizational Affiliation
U of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Pittsburgh Autism Cetner
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15217
Country
United States

12. IPD Sharing Statement

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Treatment of Sleep Disturbances in Young Children With Autism

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