Treatment of Sleep Disturbances in Young Children With Autism

Autism Clinical Trial

Official title:

Treatment of Sleep Disturbances in Young Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322022
• Other study ID #: PRO09070340
• Secondary ID: R34MH082882
• Status: Completed
• Phase: N/A
• First received: March 22, 2011
• Last updated: August 11, 2015
• Start date: December 2009
• Est. completion date: January 2013

Study information

• Verified date: January 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Months to 72 Months

Eligibility

Inclusion Criteria:

• Diagnosed with an autism spectrum disorder

• Presence of sleep disturbance

Exclusion Criteria:

• Medical etiology of sleep disturbance

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive
• Dyssomnias
• Parasomnias
• Sleep Disorders

Intervention

Behavioral:
• ParentTraining
5 sessions of individual parent training

Other:
• Parent Education
Parent Education to control for time and attention

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh Autism Cetner	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 4, and Week 8	No
Primary	Actigraphy - Sleep Efficiency	Measure of sleep efficiency defined as the percentage of time sleeping while in bed with lights off	Baseline, Week 4, Week 8	No
Primary	Actigraphy - Sleep Latency	Measure of sleep latency defined by the time from lights off to sleep onset.	Baseline, Week 4, Week 8	No
Secondary	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.	Baseline, Week 4, Week 8	No