Child Clinical Trial
Official title:
Use of an Educational Story to Prepare Children With Developmental Disabilities for Overnight Polysomnography
The investigators hypothesize that use of an educational story with pictures illustrating overnight sleep study procedure (also called polysomnography or PSG)accompanied by simple narrative will be a cost-effective, readily accepted intervention that will contribute to successful completion of sleep studies among children with disabilities. Children who have been referred for a clinical sleep study at Kennedy Krieger Institute (KKI) will be enrolled and randomized to either recieve usual care (discussion of polysomnography with referring clinicians) or educational story intervention. Both groups of participants will be asked to complete questionnaries before and after the sleep study. Set-up for the sleep study will be videotaped so that behavior of the child can be evaluated. The investigators will evaluate whether successful study completion differs between the two groups.
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:
1. Demographic questionnaire
2. Pre-PSG knowledge questionnaire
3. Pediatric Symptom Checklist
4. 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:
1. Post-PSG knowledge questionnaire (on arrival at the laboratory)
2. 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:
1. Adapted Wong-Baker FACES distress scale (based on child distress)
2. 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:
1. The PSG will be scored per laboratory protocol by a certified registered PSG
technician.
2. 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.
3. 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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
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