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Treatment of Sleep Disturbances in Young Children With Autism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01322022
First Posted: March 24, 2011
Last Update Posted: August 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pittsburgh
Results First Submitted: December 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Autism
Autism Spectrum Disorders
Interventions: Behavioral: ParentTraining
Other: Parent Education

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.)

Participant Flow:   Overall Study
    Parent Training   Parent Education
STARTED   20   20 
Week 4   15   18 
COMPLETED   15   18 
NOT COMPLETED   5   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.)
Total Total of all reporting groups

Baseline Measures
   Parent Training   Parent Education   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   18   33 
Age 
[Units: Participants]
     
<=18 years   15   18   33 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Full Range)
 3.51 
 (2 to 6) 
 3.6 
 (2 to 6) 
 3.56 
 (2 to 6) 
Gender 
[Units: Participants]
     
Female   4   3   7 
Male   11   15   26 
Region of Enrollment 
[Units: Participants]
     
United States   15   18   33 


  Outcome Measures
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1.  Primary:   Modified Simond & Parraga Sleep Questionnaire (MSPSQ) - Composite Sleep Index   [ Time Frame: Baseline, Week 4, and Week 8 ]

2.  Primary:   Actigraphy - Sleep Efficiency   [ Time Frame: Baseline, Week 4, Week 8 ]

3.  Primary:   Actigraphy - Sleep Latency   [ Time Frame: Baseline, Week 4, Week 8 ]

4.  Secondary:   Actigraphy - Total Sleep Time   [ Time Frame: Baseline, Week 4, Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: cynthia.rheney.johnson@gmail.com



Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01322022     History of Changes
Other Study ID Numbers: PRO09070340
R34MH082882 ( U.S. NIH Grant/Contract )
First Submitted: March 22, 2011
First Posted: March 24, 2011
Results First Submitted: December 4, 2014
Results First Posted: February 2, 2015
Last Update Posted: August 25, 2015