Cleft PalateBOOSTNCT06338319
Book Sharing for Toddlers With Clefts
A study testing Book-Sharing for Toddlers with Clefts (BOOST) in people with Cleft Palate and Cleft Lip and Palate, run by Seattle Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 32 months
- Conditions the study is for
- Cleft Palate, Cleft Lip and Palate
- What is being tested?
- Book-Sharing for Toddlers with Clefts (BOOST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 32 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98101
About this study
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.
- Conditions
- Cleft Palate, Cleft Lip and Palate
- Being tested
- Book-Sharing for Toddlers with Clefts (BOOST)
- Medical subject headings
- Cleft Palate, Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Book-Sharing for Toddlers with Clefts (BOOST)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BOOST Program | Experimental | Parents in the BOOST Program group will receive books to read with their children and send smartphone video recordings of their reading interactions.
To provide support, parents will participate in 3 remote, parent-focused book-sharing intervention sessions Receives: Behavioral: Book-Sharing for Toddlers with Clefts (BOOST) |
| Standard of Care Comparison Group | No intervention | Parents in the Standard of Care Comparison Group will receive books to read with their children and send smartphone video recordings of their reading interactions. Parents in the comparison group will not participate in BOOST intervention sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expressive One Word Picture Vocabulary Test-Fourth Edition
Standardized, clinician-administered measure of expressive language. Possible raw scores range from 0 to 190, with higher scores indicating better expressive language
Measured: End of study (At least 8 weeks after the end of the intervention period)
Receptive One Word Picture Vocabulary Test-Fourth Edition
Standardized, clinician-administered measure of receptive language. Raw scores range from 0 to 190, with higher scores indicating better receptive language.
Measured: End of study (At least 8 weeks after the end of the intervention period)
Child Language Sample
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.
Measured: End of study (At least 8 weeks after the end of the intervention period)
MacArthur-Bates Communicative Development Inventory - Computer Adaptive Test
Parent report measure of children's expressive language. Raw scores range from 0 to 50, with higher scores indicating better expressive language.
Measured: Baseline and at end of study (at least 8 weeks after the end of the intervention period)
Secondary outcomes (1)
Child Speech Sample - Percent Consonants Correct - Revised, Total Number of Unique Consonants
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.
Measured: Baseline and at end of study (at least 8 weeks after the end of the intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 May 2024
- Primary completionJun 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Nationwide Children's Hospital, Children's Hospital Los Angeles, Ohio State University
- Responsible party
- Sponsor
- Investigators
- Brent Collett, PhD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338319
- Sponsor's protocol ID
- 23-048-E
- Acronym
- BOOST
- Status last verified
- May 2025
- First submitted
- 22 Mar 2024
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Book Sharing for Toddlers With Clefts
- ClinicalTrials.gov ID
- NCT06338319
- Acronym / sponsor ID
- BOOST / 23-048-E
- Conditions
- Cleft Palate, Cleft Lip and Palate
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- University of Washington, Nationwide Children's Hospital, Children's Hospital Los Angeles, Ohio State University
- Study start
- 1 May 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOOST Program | Experimental | Behavioral: Book-Sharing for Toddlers with Clefts (BOOST)Parents in the BOOST Program group will receive books to read with their children and send smartphone video recordings of their reading interactions. To provide support, parents will participate in 3 remote, parent-focused book-sharing intervention sessions |
| Standard of Care Comparison Group | No intervention | –Parents in the Standard of Care Comparison Group will receive books to read with their children and send smartphone video recordings of their reading interactions. Parents in the comparison group will not participate in BOOST intervention sessions. |
Who may qualify
- Ages
- 20 to 32 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Book-Sharing for Toddlers with Clefts (BOOST)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. | Behavioural | BOOST Program |
Primary outcome
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
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.
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.
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
Related trials for Cleft Palate
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Furlow With Buccinator and Fistula Formation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brent Collett, PhD principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Book-Sharing for Toddlers with Clefts (BOOST) in people with Cleft Palate and Cleft Lip and Palate, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expressive One Word Picture Vocabulary Test-Fourth Edition (time frame: End of study (At least 8 weeks after the end of the intervention period)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.