- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02132273
Use of an Educational Story to Prepare Children With Developmental Disabilities for Sleep Study
Use of an Educational Story to Prepare Children With Developmental Disabilities for Overnight Polysomnography
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This pilot study is a prospective clinical trial comparing parent knowledge of, and child outcomes for clinically indicated PSG which is part of routine care. Comparisons will take place before and after either educational intervention or usual clinical care preparing children for PSG at KKI. Interested families will be recruited through the Kennedy Krieger Institute (KKI) Sleep Disorders Clinic and flyers will be distributed to other KKI subspecialty clinics in which clinically indicated PSG may be ordered. Families for whose children PSG is clinically recommended in KKI Sleep Disorders Clinic will have informed consent obtained from parents and assent from children in clinic, and randomization will occur at that time. Alternately, families for whose children PSG is clinically recommended in that clinic or others may contact the research coordinator for phone screening (telephone script attached) in order to be consented and assented; randomization will then take place once informed consent is received. Families randomized to the educational story intervention group will receive a printed copy of the educational story, as well as instructions on how to use it. Families randomized to the standard clinical care group will receive a set of pictures used in standard clinical care without an accompanying educational story.
The educational story has been developed by the Primary Investigator, who is board certified in Pediatrics and Sleep Medicine, and the Co-Investigator, who has extensive training in child clinical and pediatric psychology. It has also been reviewed by professionals at the KKI Center for Autism and Related Disorders with experience in developing educational materials for children with disabilities. There is a single version of this story that parents will be given to take home and review with their child. It is a short, upbeat narrative about a boy who comes to the investigators pediatric sleep laboratory for his first PSG. It is illustrated with color photographs depicting the entire PSG process (arrival at the laboratory, each step of PSG setup, the final appearance of the child with monitoring applied, the child asleep, and departure the following morning after a successful PSG). The text has a Flesch-Kincaid grade level of 2.5, and Flesch reading ease of 89.4.
Research procedures prior to PSG include completion of the following questionnaires:
- Demographic questionnaire
- Pre-PSG knowledge questionnaire
- Pediatric Symptom Checklist
- Parent Beliefs Scale
These questionnaires will be done 2-3 weeks prior to the night of the PSG.
All families will receive a phone call one week prior to PSG reminding them of their upcoming procedure, and for families in the intervention group, reminding them to review the social story. Parents in the intervention group will be asked to review the story at least 3 times with their child.
Research procedures for parents on arrival the night of the clinically indicated PSG include the following:
- Post-PSG knowledge questionnaire (on arrival at the laboratory)
- Parent Beliefs Scale (on arrival at the laboratory)
Because Dr. Paasch and Dr. Accardo are blinded to the randomization of study subjects, they will be able to score pre-PSG questionnaires and enter data as needed throughout the study.
Research procedures to be completed by sleep technicians the night of the study are the following:
- Adapted Wong-Baker FACES distress scale (based on child distress)
- Audio and video recording of equipment setup. Clinical PSG is accompanied by audio and video recording as part of routine care, but the investigators will extend the video recording to include equipment setup specifically for the purpose of research in order to quantify duration of setup time and number of escape behaviors.
Research procedures for parents prior to discharge from the laboratory will consist of a post-PSG qualitative questionnaire (prior to discharge from the laboratory) regarding their experience in the laboratory. In the case of the intervention group, they will also be asked how the educational story was helpful and whether parents recommended changes to make it more helpful in future.
After completion of the PSG and completion of questionnaires, the study is complete. Therefore the average length of time over which the study takes place, is approximately 3-4 weeks.
Following completion of the clinically indicated PSG performed for clinical care purposes, several steps will occur:
- The PSG will be scored per laboratory protocol by a certified registered PSG technician.
- The Primary Investigator, Dr. Accardo, will review data and generate a clinical interpretation of the PSG detailing whether any sleep concerns or diagnoses were identified during the study.
- Audio and video recording will be reviewed by co-investigator Dr. Valerie Paasch based on the Pediatric Behavior Adjustment Scale (PBAS) to document any child distress and complete task analysis to document the steps which were completed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Kennedy Krieger Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical recommendation for polysomnography to be performed at KKI Clinical Neurophysiology Laboratory
- age 4 -17 years
- adequate health to tolerate procedure without additional nursing care
- English speaking caregiver, over 18 years of age
- Caregiver must have full guardianship of child participant
- Caregiver must be able to complete written questionnaires and read the educational story to their child
- Caregiver must be able to accompany child participant to the sleep study
Exclusion Criteria:
- non-english speaking children
- children in foster care or wards of the state
- child with absence of developmental disability
- child with presence of severe-profound intellectual disability
- child with severe disruptive or aggressive behaviors
- recommended for titration study (CPAP and/or supplemental oxygen)
- children requiring behavioral desensitization prior to sleep study.
- Caregivers that are non-English Speaking
- Caregivers that are under 18 years of age
- foster parents or temporary guardians
- cargivers with inability to reach educational story and/or complete questionnaires.
- caregiver is unable to accompany the child to the sleep study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Educational Story
Participants receiving this intervention will have access to the educational story as they prepare for the overnight sleep study.
|
Educational story with pictures illustrating overnight polysomnography procedure accompanied by simple narrative.
Other Names:
|
No Intervention: Typical Preparation
Participants will receive traditional materials, directions, what to bring list, only.
They will not recieve access to educational story
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Task Analysis and Pediatric Behavior Adjustment Scale
Time Frame: PSG Set-UP 2- 3 weeks after enrollment
|
Task Analysis: Quantification of number of PSG steps technician was able to complete during setup Pediatric Behavior Adjustment Scale: Quantification of child escape behaviors during PSG equipment setup based on standardized review of audio and video recording |
PSG Set-UP 2- 3 weeks after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent Completed Questionnaires
Time Frame: 2-3 weeks prior to PSG, and night of Sleep Study
|
|
2-3 weeks prior to PSG, and night of Sleep Study
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Educational Story Questionnaire
Time Frame: Morning after PSG (Treatment Group Only) 3-4 weeks after enrollment.
|
Evaluation pf the parent's use and beliefs regarding the effectiveness of the educational story
|
Morning after PSG (Treatment Group Only) 3-4 weeks after enrollment.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer Accardo, MD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100-EP-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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