Treatment of Sleep Disturbances in Young Children With Autism

NCT01322022 | Completed Results DMC

• 2 other identifiers: PRO09070340R34MH082882
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Autism Spectrum Disorders

Keywords

Autism; Autism Spectrum Disorders; Sleep Problems; Sleep Disturbances; Interventions

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Actigraphy - Sleep Latency

  Measure of sleep latency defined by the time from lights off to sleep onset.

  Baseline, Week 4, Week 8

Secondary Outcomes (1)

• Actigraphy - Total Sleep Time

  Baseline, Week 4, Week 8

Study Arms (2)

Parent Training

EXPERIMENTAL

Behavioral Intervention

Behavioral: ParentTraining

Parent Education

ACTIVE COMPARATOR

5 Sessions of individual parent education

Other: Parent Education

Interventions

ParentTraining BEHAVIORAL

5 sessions of individual parent training

Also known as: Behavioral intervention, Psychoeducational intervention

Parent Training

Parent Education OTHER

Parent Education to control for time and attention

Also known as: Control

Parent Education

Eligibility Criteria

• Age: 24 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Medical etiology of sleep disturbance

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Children's Hospital of Pittsburgh Autism Cetner

Pittsburgh, Pennsylvania, 15217, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder; Parasomnias

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Cynthia Johnson
• Organization: Children's Hospital of Pittsburgh/University of Pittsburgh

cynthia.rheney.johnson@gmail.com

412-692-8404

Study Officials

• Cynthia R Johnson, PhD

  U of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 24, 2011
• Study Start: December 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2013
• Last Updated: August 25, 2015
• Results First Posted: February 2, 2015

Record last verified: 2015-01

Locations

US (1)