Use of an Educational Story to Prepare Children With Developmental Disabilities for Sleep Study
Condition: Developmental Disabilities; Sleep Disorders; Polysomnography; Preparation for Medical Procedure; Child
MeSH terms: Sleep Wake Disorders; Developmental Disabilities
Study type: Interventional

Summary: 
      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.
    

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:

        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.
    

Intervention name(s): Educational Story
Intervention type(s): Other
Intervention description(s): Educational story with pictures illustrating overnight polysomnography procedure accompanied by simple narrative.
Other intervention name(s): "The Sleep Study Story"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research