Book Sharing for Toddlers With Clefts (NCT06338319) | Clinical Trial Compass
By InvitationNot Applicable
Book Sharing for Toddlers With Clefts
United States320 participantsStarted 2024-05-01
Plain-language summary
Children with clefts exhibit difficulty with language and literacy compared to children without clefts. However, little is known about interventions to address these difficulties in the cleft population. This study will test the efficacy of a parent-focused dialogic book-sharing intervention for toddlers with isolated cleft palate. The study will use a randomized controlled trial (RCT) design and Intention to Treat (ITT) analyses. Child outcomes include expressive and receptive language. Parent outcomes of interest include the frequency and quality of shared reading interactions. To assess mechanisms of action, the study will test whether changes in child outcomes are mediated by changes in parents' behavior. Analyses will also explore heterogeneity in outcomes to determine whether the intervention is more effective in certain clinical or demographic sub-groups.
Who can participate
Age range
20 Months – 32 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* A child's parent or primary caregiver provides a signed and dated informed consent form and permission for their child to participate.
* A child's parent is willing to comply with all study procedures and be available for the duration of the study.
* Child is between the ages of 20 to 32 months at the time of enrollment.
* Child has been diagnosed with isolated cleft palate, with or without cleft lip.
* Child has received palate repair surgery.
* The family's preferred language is English or Spanish.
* The family has access to a smartphone or similar device (e.g., tablets) capable of recording and sending videos.
Exclusion Criteria:
* Diagnosed genetic condition associated with developmental delay (e.g., 22q11 deletion).
* The child has a diagnosis of autism spectrum disorder
* The child has a tracheostomy tube
* Child delivered \< 32 weeks' gestation.
* Child in state custody or foster care.
* Child with significant sensory impairment (blindness, sensorineural hearing loss).
* The caregiver speaks a language other than English or Spanish
* The caregiver does not own a smartphone or similar device capable of recording/sending video
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Expressive One Word Picture Vocabulary Test-Fourth Edition
Timeframe: End of study (At least 8 weeks after the end of the intervention period)
2
Receptive One Word Picture Vocabulary Test-Fourth Edition
Timeframe: End of study (At least 8 weeks after the end of the intervention period)
3
Child Language Sample
Timeframe: End of study (At least 8 weeks after the end of the intervention period)
4
MacArthur-Bates Communicative Development Inventory - Computer Adaptive Test
Timeframe: Baseline and at end of study (at least 8 weeks after the end of the intervention period)