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Abstract
Background: Speech and language therapy is typically initiated reactively after a child starts showing delays. Infants with classic galactosemia (CG), a metabolic disease with a known high risk for both speech and language disorders, hold the keys towards evaluating whether preventive treatment is effective when the risks are known at birth. We present pilot data from a randomized parallel trial of an innovative proactive speech and language intervention program, the Babble Boot Camp (BBC). Method: Five children with CG, otherwise healthy, participated in the study from approximately 2 to 24 months of age. One of these was randomly selected as control receiving conventional management, which typically starts at age 2-3 years. A pediatric speech-language pathologist met weekly via telepractice with the parents in the treatment cohort. Parents implemented the prespeech, speech, and language stimulation and expansion activities according to the intervention protocol. The control child was still too young for conventional treatment. Primary outcome measures were speech sound production complexity in babble and speech and expressive vocabulary size. Secondary outcome measures were vocalization rates and developmental milestones in communication, motor, and cognition. The trial is ongoing. Results: All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, three had higher global developmental scores, and two had higher vocalization rates, compared to the control child with CG. Discussion: Given the high risk for speech and language delays in children with CG, finding on-schedule abilities in two or more of the treated children but not the untreated child is unexpected under random conditions. The trends toward beneficial effects of the BBC on speech sound production, expressive language, and communication milestones warrant appropriately powered larger clinical trials with full randomization. Trial registration: ClinicalTrials.gov NCT03838016 (12 th February 2019).
Highlights
The Introduction section is much improved and the focus on child outcomes is made clear
Mean Babbling Level (MBL) MBL scores of the children with classic galactosemia (CG) in the treatment cohort consistently exceeded those of the control child with CG and typical control children without CG reported in the literature (Morris, 2010) (Figure 1)
For the ages for which data were available for the control child with CG and the typical literature-based control children without CG (12, 15, 18, and 20 months, as listed in the literature (Morris, 2010), the average difference was 0, indicating that the control child with CG obtained MBL scores equivalent to the typically developing children without CG, but note the declining trend for the control child with CG at the most recent ages
Summary
The Introduction section is much improved and the focus on child outcomes is made clear. The authors review literature on parent training with this age group, but, linking to the pilot study Methods and/or Results sections, no data is presented to evaluate fidelity of treatment by the parents, a critical issue in evaluating child outcomes in is presented to evaluate fidelity of treatment by the parents, a critical issue in evaluating child outcomes in a parent training based study. This is a structural flaw in the pilot study as it is presented for publication at present that precludes valid evaluation of this pilot study of child outcome variables.
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