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Trial Outcomes & Findings for Treatment of Sleep Disturbances in Young Children With Autism (NCT NCT01322022)

NCT ID: NCT01322022

Last Updated: 2015-08-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Baseline, Week 4, and Week 8

Results posted on

2015-08-25

Participant Flow

Participant milestones

Participant milestones
Measure
Parent Training
5 sessions of individual parent training to address sleep problems in young children with autism
Parent Education
5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
Overall Study
STARTED
20
20
Overall Study
Week 4
15
18
Overall Study
COMPLETED
15
18
Overall Study
NOT COMPLETED
5
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Sleep Disturbances in Young Children With Autism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Parent Training
n=15 Participants
5 sessions of individual parent training to address sleep problems in young children with autism
Parent Education
n=18 Participants
5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
Total
n=33 Participants
Total of all reporting groups
Age, Categorical
<=18 years
15 Participants
n=93 Participants
18 Participants
n=4 Participants
33 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Continuous
3.51 years
n=93 Participants
3.6 years
n=4 Participants
3.56 years
n=27 Participants
Sex: Female, Male
Female
4 Participants
n=93 Participants
3 Participants
n=4 Participants
7 Participants
n=27 Participants
Sex: Female, Male
Male
11 Participants
n=93 Participants
15 Participants
n=4 Participants
26 Participants
n=27 Participants
Region of Enrollment
United States
15 participants
n=93 Participants
18 participants
n=4 Participants
33 participants
n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Parent Training
n=15 Participants
5 sessions of individual parent training to address sleep problems in young children with autism
Parent Education
n=18 Participants
5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
Modified Simond & Parraga Sleep Questionnaire (MSPSQ) - Composite Sleep Index
Baseline
6.53 units on a scale
Standard Deviation 2.17
7.44 units on a scale
Standard Deviation 2.60
Modified Simond & Parraga Sleep Questionnaire (MSPSQ) - Composite Sleep Index
Week 4
4.80 units on a scale
Standard Deviation 2.68
6.83 units on a scale
Standard Deviation 2.50
Modified Simond & Parraga Sleep Questionnaire (MSPSQ) - Composite Sleep Index
Week 8
4.47 units on a scale
Standard Deviation 2.90
6.28 units on a scale
Standard Deviation 2.68

PRIMARY outcome

Timeframe: Baseline, Week 4, Week 8

Measure of sleep efficiency defined as the percentage of time sleeping while in bed with lights off

Outcome measures

Outcome measures
Measure
Parent Training
n=15 Participants
5 sessions of individual parent training to address sleep problems in young children with autism
Parent Education
n=18 Participants
5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
Actigraphy - Sleep Efficiency
Baseline
82 Percentage of Time Sleeping
Standard Deviation 7
85 Percentage of Time Sleeping
Standard Deviation 10
Actigraphy - Sleep Efficiency
Week 4
86 Percentage of Time Sleeping
Standard Deviation 5
86 Percentage of Time Sleeping
Standard Deviation 8
Actigraphy - Sleep Efficiency
Week 8
85 Percentage of Time Sleeping
Standard Deviation 6
86 Percentage of Time Sleeping
Standard Deviation 10

PRIMARY outcome

Timeframe: Baseline, Week 4, Week 8

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

Outcome measures

Outcome measures
Measure
Parent Training
n=15 Participants
5 sessions of individual parent training to address sleep problems in young children with autism
Parent Education
n=18 Participants
5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
Actigraphy - Sleep Latency
Baseline
35 minutes
Standard Deviation 31
29 minutes
Standard Deviation 27
Actigraphy - Sleep Latency
Week 4
36 minutes
Standard Deviation 20
27 minutes
Standard Deviation 23
Actigraphy - Sleep Latency
Week 8
33 minutes
Standard Deviation 26
29 minutes
Standard Deviation 22

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Parent Training
n=15 Participants
5 sessions of individual parent training to address sleep problems in young children with autism
Parent Education
n=18 Participants
5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
Actigraphy - Total Sleep Time
Baseline
455 minutes
Standard Deviation 73
448 minutes
Standard Deviation 90
Actigraphy - Total Sleep Time
Week 4
444 minutes
Standard Deviation 94
439 minutes
Standard Deviation 82
Actigraphy - Total Sleep Time
Week 8
460 minutes
Standard Deviation 60
434 minutes
Standard Deviation 90

Adverse Events

Parent Training

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Parent Education

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cynthia Johnson

Children's Hospital of Pittsburgh/University of Pittsburgh

Phone: 412-692-8404

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place