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1. Progesterone for Neurodevelopment in Fetuses With Congenital Heart Defects: A Randomized Clinical Trial

   https://doi.org/10.1001/jamanetworkopen.2024.12291  

   Gaynor, J William; Moldenhauer, Julie S; Zullo, Erin E; Burnham, Nancy B; Gerdes, Marsha; Bernbaum, Judy C; D’Agostino, Jo Ann; Linn, Rebecca L; Klepczynski, Brenna; Randazzo, Isabel; et al (May 2024, JAMA Network Open)

   ImportanceNeurodevelopmental outcomes for children with congenital heart defects (CHD) have improved minimally over the past 20 years. ObjectivesTo assess the feasibility and tolerability of maternal progesterone therapy as well as the magnitude of the effect on neurodevelopment for fetuses with CHD. Design, Setting, and ParticipantsThis double-blinded individually randomized parallel-group clinical trial of vaginal natural progesterone therapy vs placebo in participants carrying fetuses with CHD was conducted between July 2014 and November 2021 at a quaternary care children’s hospital. Participants included maternal-fetal dyads where the fetus had CHD identified before 28 weeks’ gestational age and was likely to need surgery with cardiopulmonary bypass in the neonatal period. Exclusion criteria included a major genetic or extracardiac anomaly other than 22q11 deletion syndrome and known contraindication to progesterone. Statistical analysis was performed June 2022 to April 2024. InterventionParticipants were 1:1 block-randomized to vaginal progesterone or placebo by diagnosis: hypoplastic left heart syndrome (HLHS), transposition of the great arteries (TGA), and other CHD diagnoses. Treatment was administered twice daily between 28 and up to 39 weeks’ gestational age. Main Outcomes and MeasuresThe primary outcome was the motor score of the Bayley Scales of Infant and Toddler Development-III; secondary outcomes included language and cognitive scales. Exploratory prespecified subgroups included cardiac diagnosis, fetal sex, genetic profile, and maternal fetal environment. ResultsThe 102 enrolled fetuses primarily had HLHS (n = 52 [50.9%]) and TGA (n = 38 [37.3%]), were more frequently male (n = 67 [65.7%]), and without genetic anomalies (n = 61 [59.8%]). The mean motor score differed by 2.5 units (90% CI, −1.9 to 6.9 units;P = .34) for progesterone compared with placebo, a value not statistically different from 0. Exploratory subgroup analyses suggested treatment heterogeneity for the motor score for cardiac diagnosis (Pfor interaction = .03) and fetal sex (Pfor interaction = .04), but not genetic profile (Pfor interaction = .16) or maternal-fetal environment (Pfor interaction = .70). Conclusions and RelevanceIn this randomized clinical trial of maternal progesterone therapy, the overall effect was not statistically different from 0. Subgroup analyses suggest heterogeneity of the response to progesterone among CHD diagnosis and fetal sex. Trial RegistrationClinicalTrials.gov Identifier:NCT02133573 

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2. Teaching little kids big sentences: A randomized controlled trial showing that children with DLD respond to complex syntax intervention embedded within the context of preschool/kindergarten science instruction

   https://doi.org/10.1111/1460-6984.12882  

   Owen Van Horne, Amanda J.; Curran, Maura; Cook, Susan Wagner; Cole, Renée; McGregor, Karla K. (May 2023, International Journal of Language & Communication Disorders)

   Abstract BackgroundThe language of the science curriculum is complex, even in the early grades. To communicate their scientific observations, children must produce complex syntax, particularly complement clauses (e.g.,I think it will float;We noticed that it vibrates). Complex syntax is often challenging for children with developmental language disorder (DLD), and thus their learning and communication of science may be compromised. AimsWe asked whether recast therapy delivered in the context of a science curriculum led to gains in complement clause use and scientific content knowledge. To understand the efficacy of recast therapy, we compared changes in science and language knowledge in children who received treatment for complement clauses embedded in a first‐grade science curriculum to two active control conditions (vocabulary + science, phonological awareness + science). Methods & ProceduresThis 2‐year single‐site three‐arm parallel randomized controlled trial was conducted in Delaware, USA. Children with DLD, not yet in first grade and with low accuracy on complement clauses, were eligible. Thirty‐three 4–7‐year‐old children participated in the summers of 2018 and 2019 (2020 was cancelled due to COVID‐19). We assigned participants to arms using 1:1:1 pseudo‐random allocation (avoiding placing siblings together). The intervention consisted of 39 small‐group sessions of recast therapy, robust vocabulary instruction or phonological awareness intervention during eight science units over 4 weeks, followed by two science units (1 week) taught without language intervention. Pre‐/post‐measures were collected 3 weeks before and after camp by unmasked assessors. Outcomes & ResultsPrimary outcome measures were accuracy on a 20‐item probe of complement clause production and performance on ten 10‐item unit tests (eight science + language, two science only). Complete data were available for 31 children (10 grammar, 21 active control); two others were lost to follow‐up. Both groups made similar gains on science unit tests for science + language content (pre versus post,d= 2.9,p< 0.0001; group,p= 0.24). The grammar group performed significantly better at post‐test than the active control group (d= 2.5,p= 0.049) on complement clause probes and marginally better on science‐only unit tests (d= 2.5,p= 0.051). Conclusions & ImplicationsChildren with DLD can benefit from language intervention embedded in curricular content and learn both language and science targets taught simultaneously. Tentative findings suggest that treatment for grammar targets may improve academic outcomes. What this paper addsWhat is already known on the subjectWe know that recast therapy focused on morphology is effective but very time consuming. Treatment for complex syntax in young children has preliminary efficacy data available. Prior research provides mixed evidence as to children’s ability to learn language targets in conjunction with other information.What this study addsThis study provides additional data supporting the efficacy of intensive complex syntax recast therapy for children ages 4–7 with Developmental Language Disorder. It also provides data that children can learn language targets and science curricular content simultaneously.What are the clinical implications of this work?As SLPs, we have to talk about something to deliver language therapy; we should consider talking about curricular content. Recast therapy focused on syntactic frames is effective with young children. 

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3. Evidence for machine learning guided early prediction of acute outcomes in the treatment of depressed children and adolescents with antidepressants

   https://doi.org/10.1111/jcpp.13580  

   Athreya, Arjun P.; Vande Voort, Jennifer L.; Shekunov, Julia; Rackley, Sandra J.; Leffler, Jarrod M.; McKean, Alastair J.; Romanowicz, Magdalena; Kennard, Betsy D.; Emslie, Graham J.; Mayes, Taryn; et al (March 2022, Journal of Child Psychology and Psychiatry)

   BackgroundThe treatment of depression in children and adolescents is a substantial public health challenge. This study examined artificial intelligence tools for the prediction of early outcomes in depressed children and adolescents treated with fluoxetine, duloxetine, or placebo. MethodsThe study samples included training datasets (N = 271) from patients with major depressive disorder (MDD) treated with fluoxetine and testing datasets from patients with MDD treated with duloxetine (N = 255) or placebo (N = 265). Treatment trajectories were generated using probabilistic graphical models (PGMs). Unsupervised machine learning identified specific depressive symptom profiles and related thresholds of improvement during acute treatment. ResultsVariation in six depressive symptoms (difficulty having fun, social withdrawal, excessive fatigue, irritability, low self‐esteem, and depressed feelings) assessed with the Children’s Depression Rating Scale‐Revised at 4–6 weeks predicted treatment outcomes with fluoxetine at 10–12 weeks with an average accuracy of 73% in the training dataset. The same six symptoms predicted 10–12 week outcomes at 4–6 weeks in (a) duloxetine testing datasets with an average accuracy of 76% and (b) placebo‐treated patients with accuracies of 67%. In placebo‐treated patients, the accuracies of predicting response and remission were similar to antidepressants. Accuracies for predicting nonresponse to placebo treatment were significantly lower than antidepressants. ConclusionsPGMs provided clinically meaningful predictions in samples of depressed children and adolescents treated with fluoxetine or duloxetine. Future work should augment PGMs with biological data for refined predictions to guide the selection of pharmacological and psychotherapeutic treatment in children and adolescents with depression. 

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4. Empatica E4 Assessment of Child Physiological Measures of Listening Effort During Remote and In-Person Communication

   https://doi.org/10.1044/2024_AJA-24-00078  

   Kondaurova, Maria V; Smith, Alan; Mishra, Ruchik; Zheng, Qi; Kondaurova, Irina; Francis, Alexander L; Sallee, Emily (December 2024, American Journal of Audiology)

   Purpose:Telepractice is a growing service model that delivers aural rehabilitation to deaf and hard-of hearing children via telecommunications technology. Despite known benefits of telepractice, this delivery approach may increase patients' listening effort (LE) characterized as an allocation of cognitive resources toward an auditory task. The study tested techniques for collecting physiological measures of LE in normal-hearing (NH) children during remote (referred to as tele-) and in-person communication using the wearable Empatica E4 wristband. Method:Participants were 10 children (age range: 9–12 years old) who came to two tele- and two in-person weekly sessions, order counterbalanced. During each session, the children heard a short passage read by the clinical provider, completed an auditory passage comprehension task, and self-rated their effort as a part of the larger study. Measures of electrodermal activity and blood volume pulse amplitude were collected from the child E4 wristband. Results:No differences in child subjective, physiological measures of LE or passage comprehension scores were found between in-person sessions and telesessions. However, an effect of treatment duration on subjective and physiological measures of LE was identified. Children self-reported a significant increase in LE over time. However, their physiological measures demonstrated a trend indicating a decrease in LE. A significant association between subjective measures and the passage comprehension task was found suggesting that those children who reported more effort demonstrated a higher proportion of correct responses. Conclusions:The study demonstrated the feasibility of collection of physiological measures of LE in NH children during remote and in-person communication using the E4 wristband. The results suggest that measures of LE are multidimensional and may reflect different sources of, or cognitive responses to, increased listening demand. Supplemental Material:https://doi.org/10.23641/asha.27122064 

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5. Protocol for visual-acoustic intervention with service delivery in-person and via telepractice (VISIT) non-inferiority trial for residual speech sound disorder

   https://doi.org/10.1186/s12887-024-05364-z  

   McAllister, Tara; Preston, Jonathan L; Hitchcock, Elaine R; Benway, Nina R; Hill, Jennifer (January 2025, BMC Pediatrics)

   Background Residual speech sound disorder (RSSD) is a high-prevalence condition that negatively impacts social and academic participation. Telepractice service delivery has the potential to expand access to technology-enhanced intervention methods that can help remediate RSSD, but it is not known whether remote service delivery is associated with a reduction in the efficacy of these methods. This project will systematically measure the outcomes of visual-acoustic biofeedback intervention when delivered in-person or online. Methods/design This project, Visual-acoustic Intervention with Service delivery In-person and via Telepractice (VISIT), aims to treat 76 children in a parallel randomized controlled clinical trial in which children with RSSD will receive visual-acoustic biofeedback treatment either in person or via telepractice. Eligible children will be speakers of American English aged 9–17 years who exhibit RSSD affecting /ɹ/ but otherwise show cognitive-linguistic and hearing abilities within the typical range. All participants will receive twenty sessions of visual-acoustic biofeedback; they will be randomized, with stratification by pre-treatment speech production ability and site, to complete their treatment sessions either in the laboratory setting or at home via telepractice. For the primary outcome measure, blinded listeners will evaluate changes in the perceived accuracy of /ɹ/ production after the end of treatment. Discussion By comparing outcomes in children randomized to receive a standard course of biofeedback treatment either via telepractice or in-person, this study will provide evidence-based guidance for clinicians seeking flexible service delivery options for a challenging and prevalent condition. 

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