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Enrolling by Invitation

NCT Number: NCT06338319

Book Sharing for Toddlers With Clefts

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.

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Key information

Conditions

Cleft Palate Cleft Lip Cleft Lip and Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

20 month–32 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98101, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Book-Sharing for Toddlers with Clefts (BOOST)

Behavioral

BOOST is a dialogic book-sharing intervention. Topics covered include strategies to increase the frequency of shared reading, child engagement and involvement in reading, and strategies to promote language development. Handouts will be shared during the sessions (using the Zoom share screen feature) and sent to families to summarize the content. Parents will record and securely upload shared reading videos during the intervention period. The research team will send prompts for these video uploads after each intervention session. Interventionists will review these videos between sessions to identify parent strengths, application of target skills, and opportunities for improvement.

Primary outcomes

  1. Expressive One Word Picture Vocabulary Test-Fourth Edition

    Time frame: End 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

  2. Receptive One Word Picture Vocabulary Test-Fourth Edition

    Time frame: End 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.

  3. Child Language Sample

    Time frame: End 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.

  4. MacArthur-Bates Communicative Development Inventory - Computer Adaptive Test

    Time frame: Baseline 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.

Secondary outcomes

  1. Child Speech Sample - Percent Consonants Correct - Revised, Total Number of Unique Consonants

    Time frame: Baseline and at end of study (at least 8 weeks after the end of the intervention period)

    Parent-administered measure to assess children's speech sound inventory and production accuracy. Children will be asked to name approximately 27 pictures. Responses will be recorded and phonetically transcribed to obtain a count of consonant sounds attempted and consonant sounds correct in the beginning, middle, and final positions for the pictured words. We will use these counts to obtain percent consonants correct - revised (#consonants correct/#consonants attempted). Higher scores indicate better speech sound accuracy. We will also count the total number of unique consonants produced, with higher scores indicating larger phonetic inventory.

Other outcomes

  1. Frequency of Shared Reading

    Time frame: Throughout the intervention period of approximately 8 weeks and again at end of study (at least 8 weeks after the end of the intervention period)

    Parent report measure of shared reading, reported as the number of books read with their child in the last 24-hours. Higher scores indicate more frequent shared reading.

  2. Quality of Shared Reading

    Time frame: Throughout the intervention period of approximately 8 weeks and again at end of study (at least 8 weeks after the end of the intervention period)

    Observational measure of parent-child reading interactions, including a count of the dialogic book-sharing strategies used during the observation. Higher scores indicate higher quality shared reading interaction.

  3. Child Language During Reading

    Time frame: Throughout the intervention period of approximately 8 weeks and again at end of study (at least 8 weeks after the end of the intervention period)

    Observation of child language during reading interactions, including a count of the number of clear and intelligible utterances the child uses, the number of unique words, and the mean length of utterance. Higher scores will indicate better observed child language skills.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • Children's Hospital Los Angeles
  • Nationwide Children's Hospital
  • Ohio State University
  • University of Washington

Registry information

Acronym: BOOST

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 29, 2024
Registry last updated
May 23, 2025

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.

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