Babble Boot Camp focuses on early speech and language development, environmental enrichment and supporting parent-infant interaction with the aim of improving communication outcomes and parental well-being in at risk children.
The goal of this clinical trial is to learn if this parent-coaching speech therapy intervention delivered via telehealth helps to support babies born very preterm with their earliest stages of communication.
The main questions it aims to answer are:
Does Babble Boot Camp increase language outcomes in infants born very preterm? Is Babble Boot Camp able to be successfully completed by caregivers, and do caregivers believe Babble Boot Camp is possible to implement at home? What is the family impact of Babble Boot Camp?
Participants will:
Be randomly assigned into either a "treatment group" or a "usual care group." If allocated into the treatment group using Babble Boot Camp, participants will attend weekly 15-minute therapy sessions with a speech pathologist for 6 months.
Both groups ("treatment group" or a "usual care group") will complete questionaries at enrollment and when the child participant is 6, and 12 months old (corrected age).
Infants born <32 weeks' gestational age (GA)
Infants medically stable and not ventilator dependent at recruitment
Primary language spoken at home is English
Participants able to attend 6 months of telehealth early intervention
Diagnosis of a chromosomal or genetic anomaly known to affect development,
Significant hearing and vision loss
Clefting of the lip or palate
Hypoxic ischemic encephalopathy
Parallel
Babble Boot Camp
BehavioralThe intervention will be delivered by the following method: Weekly 15-minute telehealth sessions with topics around understanding and responding to infant behaviour, promoting development through enhanced parent child interaction and demonstrating intervention activities. Toys will be used to facilitate language development with parents coached on appropriate interactions. During these sessions, the therapist will coach the parent to deliver intervention activities with their infant during daily routines and activities. The parent will record 2-3 short videos of their child to be submitted to the therapist weekly prior to the telehealth session.
Mean difference between arms in the Language ability composite score as assessed by the Receptive-Expressive Emergent Language Test-Fourth Edition (REEL-4)
The REEL-4 Language ability composite score combines the expressive language and receptive language subtests of the standardized assessment into one score to measure the overall language ability of a participant. The REEL-4 is a standardized assessment using standard scores ranging from 40 to 160, with an average score of 100. Scores are interpreted using standard deviation units of 15 points, meaning scores between 85 and 115 fall within the typical range.
Mean percentage of parent-submitted videos that include at least one BBC program communication component (BBC Intervention group) [measuring parent compliance]
Parents in the BBC treatment group will submit videos of their child during the duration of the trial to assess the use of BBC in daily routines successfully. Compliance with use of BBC components is defined as a video submitted containing the use of at least one BBC communication component. Parent compliance in the BBC treatment group will be summarised as the mean percentage of videos successfully including communication components.
Acceptability of the trial to caregivers using the Theoretical Framework of Acceptability (TFA)
Caregiver's views of the trial using the Theoretical Framework of Acceptability will be measured using an adapted questionnaire from Sekhon et.al., modified for the BBC Prem intervention to assess the design, evaluation, and implementation of the intervention (Sekhon et.al., 2022). Likert scales will be used to measure several items - scores will range from 1-5, where higher scores could indicate a better or worse outcome depending on the item. The items will be summarised by reporting the median per item. Answers to open ended questions answers will be collated and themes identified will be reported.
Number of participants attending greater than 80 percent of intervention sessions
The number and percentage of participants who attended greater than 80 percent of sessions will be given.
Total distress scores of adult participants assessed using the Depression, Anxiety, and Stress Scales (DASS-21)
The Depression, Anxiety, and Stress Scales (DASS-21) total distress score will be assessed. Each item on rating scale is reported 0-3 where higher scores indicate a worse outcome. The mean difference in the total scores of the items will be reported.
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This trial is not recruiting at the moment. You can still explore other options:
