Treatment of Sleep Disturbances in Young Children With Autism
Condition: Autism; Autism Spectrum Disorders
MeSH terms: Dyssomnias; Parasomnias; Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

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.
    

Intervention name(s): ParentTraining; Parent Education
Intervention type(s): Behavioral; Other
Intervention description(s): 5 sessions of individual parent training; Parent Education to control for time and attention
Other intervention name(s): Behavioral intervention; Psychoeducational intervention; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism; Autism Spectrum Disorders; Sleep Problems; Sleep Disturbances; Interventions