Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R34MH082882 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parent Training | Experimental | Behavioral Intervention |
|
| Parent Education | Active Comparator | 5 Sessions of individual parent education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ParentTraining | Behavioral | 5 sessions of individual parent training |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cynthia R Johnson, PhD | U of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh Autism Cetner | Pittsburgh | Pennsylvania | 15217 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Parent Training | 5 sessions of individual parent training to address sleep problems in young children with autism |
| FG001 | Parent Education | 5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Parent Training | 5 sessions of individual parent training to address sleep problems in young children with autism |
| BG001 | Parent Education | 5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 4, and Week 8 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parent Training | 5 sessions of individual parent training to address sleep problems in young children with autism |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cynthia Johnson | Children's Hospital of Pittsburgh/University of Pittsburgh | 412-692-8404 | cynthia.rheney.johnson@gmail.com |
Not provided
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000067877 | Autism Spectrum Disorder |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D012893 | Sleep Wake Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Parent Education | Other | Parent Education to control for time and attention |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Parent Education | 5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.) |
|
|
| 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. | Posted | Mean | Standard Deviation | minutes | Baseline, Week 4, Week 8 |
|
|
|
| Primary | Actigraphy - Sleep Efficiency | Measure of sleep efficiency defined as the percentage of time sleeping while in bed with lights off | Posted | Mean | Standard Deviation | Percentage of Time Sleeping | Baseline, Week 4, Week 8 |
|
|
|
| Primary | Actigraphy - Sleep Latency | Measure of sleep latency defined by the time from lights off to sleep onset. | Posted | Mean | Standard Deviation | minutes | Baseline, Week 4, Week 8 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Parent Education | 5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.) | 0 | 20 | 0 | 20 |
Not provided
Not provided
| D009422 | Nervous System Diseases |
| Week 8 |
|
| Week 8 |
|
| Week 8 |
|