Use of an Educational Story to Prepare Children With Developmental Disabilities for Overnight Polysomnography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Task Analysis and Pediatric Behavior Adjustment Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Task Analysis and Pediatric Behavior Adjustment Scale
时间窗: 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
次要结局
- Parent Completed Questionnaires(2-3 weeks prior to PSG, and night of Sleep Study)
研究者
Jennifer Accardo
Assistant Professor of Neurology
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.