Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
NCT Number: NCT04863157
The purpose of the study is to learn if an educational program delivered to parents/guardians can help improve the sleep of children experiencing sleep problems after completing cancer treatment. The name of the intervention is Survivor-SHIP (Sleep Health Information Program).
Looking for future studies?
Notify Me5 year–12 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
This study will evaluate Survivor-SHIP in a single-arm trial of 20 off-treatment childhood cancer survivors (ages 5-12). The intervention is an adapted version of the family-centered Sleep Health Program designed at Seattle Children's Hospital. The program offers parents information about how to utilize evidence-based strategies for their child's sleep, and has demonstrated success in a community-based sample of children with behavioral sleep problems. Sessions will focus on providing parents with education about healthy sleep and setting targets for modifiable behaviors that can improve their child's sleep health.
The study will include 3 education sessions taking place over videoconference. Families will be asked to track their child's sleep using sleep diaries during the course of the program. Prior to, and following the program, families will be asked to complete study questionnaires.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Parent/guardian education about healthy sleep practices to improve their child's sleep health.
Other names: Survivor-Sleep Health Information Program
Time frame: 6 weeks
Intervention acceptability will be assessed using the Satisfaction subscale of the Usability, Satisfaction, and Ease of use (USE) scale. Total scores will range from 0-11, with higher scores indicating better acceptability.
Time frame: 6 weeks
Intervention feasibility will be assessed based on adherence rates to the intervention sessions.
Time frame: 6 weeks
The Parent Sleep Knowledge questionnaire is a 10-item questionnaire assessing the parents' knowledge about children's sleep. The scale is scored from 0 to 10, with a higher score indicating more knowledge.
Time frame: 6 weeks
The Children's Sleep Habits Questionnaire (CSHQ) is a 33-item questionnaire that will assess the child's overall sleep habits. A Total Sleep Disturbances score is calculated as the sum of all scored questions, and can range from 33 to 99, with higher scores indicating more sleep disturbance.
Time frame: 6 weeks
The Patient-reported outcomes measurement information system (PROMIS) pediatric sleep scales are an 8-item measure that assesses the child's sleep quality. A total score will range from 8 to 40, with higher scale scores indicating poorer sleep health
Time frame: 6 weeks
The child's quality of life will be evaluated by the Pediatric Quality of Life Inventory (PedsQL), a 23-item scale measuring core physical, mental, and social health dimensions. Scores are transformed on a scale from 0 to 100, with higher scores indicating better function.
Time frame: 6 weeks
The extent of the child's electronic screen use will be assessed by a set of 9 questions that were developed specifically for this study by the Principal Investigator. They assess the duration of electronics usage across different devices and timing of usage.
Time frame: 6 weeks
The investigators will assess whether the family implemented any non-intervention advised changes to their child's sleep routine, such as increasing medication for their sleep during the intervention period. This set of 5 questions will be assessed only at the post-intervention timepoint.
Dana-Farber Cancer Institute
Other
A Sleep Intervention for Children After Cancer: Survivor Sleep Health Information Program (Survivor-SHIP)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01669317
Dyssomnias, Insomnia
Baton Rouge, Louisiana, United States
View Trial DetailsNCT04258540
Anxiety Disorders, Behavior
Oslo, Norway
View Trial DetailsNCT04130529
Bipolar Disorder, Bipolar and Related Disorders
Stockholm, Stockholm County, Sweden
View Trial DetailsNCT05397353
Behavior, Behavioral Symptoms
Piscataway, New Jersey, United States
View Trial Details