Treatment of Sleep Disturbances in Young Children With Autism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01322022
First received: March 22, 2011
Last updated: September 13, 2011
Last verified: September 2011
  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.

Condition Intervention
Autism
Autism Spectrum Disorders
Behavioral: ParentTraining

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Sleep Disturbances in Young Children With Autism

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Modified Simond & Parraga Sleep Questionnaire (MSPSQ) [ Time Frame: Baseline, Week 4, and Week 8 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Actigraphy [ Time Frame: After the Home Visit, After the Week 4 Assessment, After the Week 8 Assessment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: December 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Parent Training Behavioral: ParentTraining
5 sessions of individual parent training
Other Names:
  • Behavioral intervention
  • Psychoeducational intervention
Active Comparator: Parent Education
5 Sessions of individual parent education
Behavioral: ParentTraining
5 sessions of individual parent training
Other Names:
  • Behavioral intervention
  • Psychoeducational intervention

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.

  Eligibility

Ages Eligible for Study:   24 Months to 72 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Medical etiology of sleep disturbance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322022

Contacts
Contact: Emily Foldes, MS 4126925840 emily.foldes@chp.edu

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh Autism Cetner Recruiting
Pittsburgh, Pennsylvania, United States, 15217
Contact: Emily Foldes, MS    412-692-5840    emily.foldes@chp.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Cynthia R Johnson, PhD U of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01322022     History of Changes
Other Study ID Numbers: PRO09070340, R34MH082882
Study First Received: March 22, 2011
Last Updated: September 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Autism
Autism Spectrum Disorders
Sleep Problems
Sleep Disturbances
Interventions

Additional relevant MeSH terms:
Autistic Disorder
Sleep Disorders
Dyssomnias
Parasomnias
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 20, 2014