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NCT06338319

Book Sharing for Toddlers With Clefts

Enrolling by Invitation
NAAges 20–32InterventionalTreatment
Seattle Children's Hospital
~320 participants
Updated 2025-05-23 on ClinicalTrials.gov
What's tested:Book-Sharing for Toddlers with Clefts (BOOST)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Expressive One Word Picture Vocabulary Test-Fourth Edition
Measured over End of study (At least 8 weeks after the end of the intervention period)
+3 more outcomes measured

Conditions

Cleft Palate
Cleft Lip and Palate

Explore related trials

Cleft PalateCleft palate with cleft lip

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Brent Collett, PhD · PRINCIPAL_INVESTIGATOR · Seattle Children's Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Expressive One Word Picture Vocabulary Test-Fourth EditionEnd of study (At least 8 weeks after the end of the intervention period)

    Standardized, clinician-administered measure of expressive language. Possible raw scores range from 0 to 190, with higher scores indicating better expressive language

  • Receptive One Word Picture Vocabulary Test-Fourth EditionEnd of study (At least 8 weeks after the end of the intervention period)

    Standardized, clinician-administered measure of receptive language. Raw scores range from 0 to 190, with higher scores indicating better receptive language.

  • Child Language SampleEnd of study (At least 8 weeks after the end of the intervention period)

    Observational measure to assess child expressive language. We will obtain a count of the number of clear and intelligible utterances, the number of unique words used, and mean length of utterance. Higher scores indicate better child language skills.

  • MacArthur-Bates Communicative Development Inventory - Computer Adaptive TestBaseline and at end of study (at least 8 weeks after the end of the intervention period)

    Parent report measure of children's expressive language. Raw scores range from 0 to 50, with higher scores indicating better expressive language.