Treatment of Sleep Disturbances in Young Children With Autism
Study Details
Study Description
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;
- 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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Parent Training Behavioral Intervention |
Behavioral: ParentTraining
5 sessions of individual parent training
Other Names:
|
| Active Comparator: Parent Education 5 Sessions of individual parent education |
Other: Parent Education
Parent Education to control for time and attention
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Modified Simond & Parraga Sleep Questionnaire (MSPSQ) - Composite Sleep Index [Baseline, Week 4, and Week 8]
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.
- Actigraphy - Sleep Efficiency [Baseline, Week 4, Week 8]
Measure of sleep efficiency defined as the percentage of time sleeping while in bed with lights off
- Actigraphy - Sleep Latency [Baseline, Week 4, Week 8]
Measure of sleep latency defined by the time from lights off to sleep onset.
Secondary Outcome Measures
- Actigraphy - Total Sleep Time [Baseline, Week 4, Week 8]
Measure of total time spent asleep using Motionlogger model actigraph by Ambulatory Monitoring, Inc. (www.ambulatory-monitoring.com) and algorithms in associated software.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed with an autism spectrum disorder
-
Presence of sleep disturbance
Exclusion Criteria:
- Medical etiology of sleep disturbance
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Pittsburgh Autism Cetner | Pittsburgh | Pennsylvania | United States | 15217 |
Sponsors and Collaborators
- University of Pittsburgh
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Cynthia R Johnson, PhD, U of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO09070340
- R34MH082882
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Parent Training | Parent Education |
|---|---|---|
| Arm/Group Description | 5 sessions of individual parent training to address sleep problems in young children with autism | 5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.) |
| Period Title: Overall Study | ||
| STARTED | 20 | 20 |
| Week 4 | 15 | 18 |
| COMPLETED | 15 | 18 |
| NOT COMPLETED | 5 | 2 |
Baseline Characteristics
| Arm/Group Title | Parent Training | Parent Education | Total |
|---|---|---|---|
| Arm/Group Description | 5 sessions of individual parent training to address sleep problems in young children with autism | 5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.) | Total of all reporting groups |
| Overall Participants | 15 | 18 | 33 |
| Age (Count of Participants) | |||
| <=18 years |
15
100%
|
18
100%
|
33
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
3.51
|
3.6
|
3.56
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
4
26.7%
|
3
16.7%
|
7
21.2%
|
| Male |
11
73.3%
|
15
83.3%
|
26
78.8%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
15
100%
|
18
100%
|
33
100%
|
Outcome Measures
| Title | Modified Simond & Parraga Sleep Questionnaire (MSPSQ) - Composite Sleep Index |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 4, and Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Parent Training | Parent Education |
|---|---|---|
| Arm/Group Description | 5 sessions of individual parent training to address sleep problems in young children with autism | 5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.) |
| Measure Participants | 15 | 18 |
| Baseline |
6.53
(2.17)
|
7.44
(2.60)
|
| Week 4 |
4.80
(2.68)
|
6.83
(2.50)
|
| Week 8 |
4.47
(2.90)
|
6.28
(2.68)
|
| Title | Actigraphy - Total Sleep Time |
|---|---|
| Description | Measure of total time spent asleep using Motionlogger model actigraph by Ambulatory Monitoring, Inc. (www.ambulatory-monitoring.com) and algorithms in associated software. |
| Time Frame | Baseline, Week 4, Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Parent Training | Parent Education |
|---|---|---|
| Arm/Group Description | 5 sessions of individual parent training to address sleep problems in young children with autism | 5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.) |
| Measure Participants | 15 | 18 |
| Baseline |
455
(73)
|
448
(90)
|
| Week 4 |
444
(94)
|
439
(82)
|
| Week 8 |
460
(60)
|
434
(90)
|
| Title | Actigraphy - Sleep Efficiency |
|---|---|
| Description | Measure of sleep efficiency defined as the percentage of time sleeping while in bed with lights off |
| Time Frame | Baseline, Week 4, Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Parent Training | Parent Education |
|---|---|---|
| Arm/Group Description | 5 sessions of individual parent training to address sleep problems in young children with autism | 5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.) |
| Measure Participants | 15 | 18 |
| Baseline |
82
(7)
|
85
(10)
|
| Week 4 |
86
(5)
|
86
(8)
|
| Week 8 |
85
(6)
|
86
(10)
|
| Title | Actigraphy - Sleep Latency |
|---|---|
| Description | Measure of sleep latency defined by the time from lights off to sleep onset. |
| Time Frame | Baseline, Week 4, Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Parent Training | Parent Education |
|---|---|---|
| Arm/Group Description | 5 sessions of individual parent training to address sleep problems in young children with autism | 5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.) |
| Measure Participants | 15 | 18 |
| Baseline |
35
(31)
|
29
(27)
|
| Week 4 |
36
(20)
|
27
(23)
|
| Week 8 |
33
(26)
|
29
(22)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Parent Training | Parent Education | ||
| Arm/Group Description | 5 sessions of individual parent training to address sleep problems in young children with autism | 5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.) | ||
All Cause Mortality |
||||
| Parent Training | Parent Education | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Parent Training | Parent Education | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/20 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Parent Training | Parent Education | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/20 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Cynthia Johnson |
|---|---|
| Organization | Children's Hospital of Pittsburgh/University of Pittsburgh |
| Phone | 412-692-8404 |
| cynthia.rheney.johnson@gmail.com |
- PRO09070340
- R34MH082882