Behavioral Outcomes of Infant Colic in Toddlerhood: A Longitudinal Study.

OBJECTIVE: To assess whether infants with colic that resolved before 6 months of age have poorer medium-term outcomes than infants without colic. STUDY DESIGN: Comparative study of 2 prospective, community-based cohorts of children aged 2-3 years in Melbourne, Australia: children from the Baby Biotics study, with previously diagnosed Wessel criteria of colic without problem crying at 6 months (True Colic Cohort), vs children from the Baby Business trial, without problem crying at 1, 4, and 6 months (No Colic Cohort). Caregiver report of child internalizing and externalizing behaviors (primary outcome), temperament, regulatory (crying/sleeping/feeding) problems, and family functioning at child age 2-3 years was collected. We conducted regression analyses of mean differences/ORs adjusted for child sex, age, social disadvantage, parental education, and maternal mental health. RESULTS: In total, 74% of the original Baby Biotics (n = 124) sample and 75% of the Baby Business (n = 503) sample completed questionnaires. In adjusted analyses, there were no significant differences between the True Colic Cohort (n = 99) and No Colic Cohort (n = 182) in internalizing behavior problems (adjusted mean difference 0.73; 95% CI -3.96 to 5.43, P = .76) or externalizing behavior problems (adjusted mean difference -1.53; 95% CI -6.02 to 2.97, P = .51). There were no statistically significant differences between groups in temperament, parental perception of regulatory problems, or family functioning. CONCLUSIONS: Infants with colic whose crying self-resolves do not experience adverse effects regarding child behavior, regulatory abilities, temperament, or family functioning in the medium term. Parents and clinicians can be reassured that infant crying as the result of colic, and related stress, is short-lived and will likely resolve.

Two-Year Outcomes of a Population-Based Intervention for Preschool Language Delay: An RCT.

OBJECTIVE: We have previously shown short-term benefits to phonology, letter knowledge, and possibly expressive language from systematically ascertaining language delay at age 4 years followed by the Language for Learning intervention. Here, we report the trial's definitive 6-year outcomes. METHODS: Randomized trial nested in a population-based ascertainment. Children with language scores >1.25 SD below the mean at age 4 were randomized, with intervention children receiving 18 1-hour home-based therapy sessions. Primary outcome was receptive/expressive language. Secondary outcomes were phonological, receptive vocabulary, literacy, and narrative skills; parent-reported pragmatic language, behavior, and health-related quality of life; costs of intervention; and health service use. For intention-to-treat analyses, trial arms were compared using linear regression models. RESULTS: Of 1464 children assessed at age 4, 266 were eligible and 200 randomized; 90% and 82% of intervention and control children were retained respectively. By age 6, mean language scores had normalized, but there was little evidence of a treatment effect for receptive (adjusted mean difference 2.3; 95% confidence interval [CI] -1.2 to 5.7; P = .20) or expressive (0.8; 95% CI -1.6 to 3.2; P = .49) language. Of the secondary outcomes, only phonological awareness skills (effect size 0.36; 95% CI 0.08-0.65; P = .01) showed benefit. Costs were higher for intervention families (mean difference AU$4276; 95% CI: $3424 to $5128). CONCLUSIONS: Population-based intervention targeting 4-year-old language delay was feasible but did not have lasting impacts on language, possibly reflecting resolution in both groups. Long-term literacy benefits remain possible but must be weighed against its cost.

Randomized trial of a population-based, home-delivered intervention for preschool language delay.

OBJECTIVE: Population approaches to lessen the adverse impacts of preschool language delay remain elusive. We aimed to determine whether systematic ascertainment of language delay at age 4 years, followed by a 10-month, 1-on-1 intervention, improves language and related outcomes at age 5 years. METHODS: A randomized trial nested within a cross-sectional ascertainment of language delay. Children with expressive and/or receptive language scores more than 1.25 SD below the mean at age 4 years entered the trial. Children randomly allocated to the intervention received 18 1-hour home-based therapy sessions. The primary outcomes were receptive and expressive language (Clinical Evaluation of Language Fundamentals - Preschool, 2(nd) Edition) and secondary outcomes were child phonological skills, letter awareness, pragmatic skills, behavior, and quality of life. RESULTS: A total of 1464 children were assessed for language delay at age 4 years. Of 266 eligible children, 200 (13.6%) entered the trial, with 91 intervention (92% of 99) and 88 control (87% of 101) children retained at age 5 years. At age 5 years, there was weak evidence of benefit to expressive (adjusted mean difference, intervention - control, 2.0; 95% confidence interval [CI] -0.5 to 4.4; P = .12) but not receptive (0.6; 95% CI -2.5 to 3.8; P = .69) language. The intervention improved phonological awareness skills (5.0; 95% CI 2.2 to 7.8; P < .001) and letter knowledge (2.4; 95% CI 0.3 to 4.5; P = .03), but not other secondary outcomes. CONCLUSIONS: A standardized yet flexible 18-session language intervention was successfully delivered by non-specialist staff, found to be acceptable and feasible, and has the potential to improve long-term consequences of early language delay within a public health framework.

Improving outcomes of preschool language delay in the community: protocol for the Language for Learning randomised controlled trial.

BACKGROUND: Early language delay is a high-prevalence condition of concern to parents and professionals. It may result in lifelong deficits not only in language function, but also in social, emotional/behavioural, academic and economic well-being. Such delays can lead to considerable costs to the individual, the family and to society more widely. The Language for Learning trial tests a population-based intervention in 4 year olds with measured language delay, to determine (1) if it improves language and associated outcomes at ages 5 and 6 years and (2) its cost-effectiveness for families and the health care system. METHODS/DESIGN: A large-scale randomised trial of a year-long intervention targeting preschoolers with language delay, nested within a well-documented, prospective, population-based cohort of 1464 children in Melbourne, Australia. All children received a 1.25-1.5 hour formal language assessment at their 4th birthday. The 200 children with expressive and/or receptive language scores more than 1.25 standard deviations below the mean were randomised into intervention or 'usual care' control arms. The 20-session intervention program comprises 18 one-hour home-based therapeutic sessions in three 6-week blocks, an outcome assessment, and a final feed-back/forward planning session. The therapy utilises a 'step up-step down' therapeutic approach depending on the child's language profile, severity and progress, with standardised, manualised activities covering the four language development domains of: vocabulary and grammar; narrative skills; comprehension monitoring; and phonological awareness/pre-literacy skills. Blinded follow-up assessments at ages 5 and 6 years measure the primary outcome of receptive and expressive language, and secondary outcomes of vocabulary, narrative, and phonological skills. DISCUSSION: A key strength of this robust study is the implementation of a therapeutic framework that provides a standardised yet tailored approach for each child, with a focus on specific language domains known to be associated with later language and literacy. The trial responds to identified evidence gaps, has outcomes of direct relevance to families and the community, includes a well-developed economic analysis, and has the potential to improve long-term consequences of early language delay within a public health framework. TRIAL REGISTRATION: Current Controlled Trials ISRCTN03981121.

Outcomes of population based language promotion for slow to talk toddlers at ages 2 and 3 years: Let's Learn Language cluster randomised controlled trial.

OBJECTIVE: To determine the benefits of a low intensity parent-toddler language promotion programme delivered to toddlers identified as slow to talk on screening in universal services. DESIGN: Cluster randomised trial nested in a population based survey. SETTING: Three local government areas in Melbourne, Australia. PARTICIPANTS: Parents attending 12 month well child checks over a six month period completed a baseline questionnaire. At 18 months, children at or below the 20th centile on an expressive vocabulary checklist entered the trial. INTERVENTION: Maternal and child health centres (clusters) were randomly allocated to intervention (modified "You Make the Difference" programme over six weekly sessions) or control ("usual care") arms. MAIN OUTCOME MEASURES: The primary outcome was expressive language (Preschool Language Scale-4) at 2 and 3 years; secondary outcomes were receptive language at 2 and 3 years, vocabulary checklist raw score at 2 and 3 years, Expressive Vocabulary Test at 3 years, and Child Behavior Checklist/1.5-5 raw score at 2 and 3 years. RESULTS: 1217 parents completed the baseline survey; 1138 (93.5%) completed the 18 month checklist, when 301 (26.4%) children had vocabulary scores at or below the 20th centile and were randomised (158 intervention, 143 control). 115 (73%) intervention parents attended at least one session (mean 4.5 sessions), and most reported high satisfaction with the programme. Interim outcomes at age 2 years were similar in the two groups. Similarly, at age 3 years, adjusted mean differences (intervention-control) were -2.4 (95% confidence interval -6.2 to 1.4; P=0.21) for expressive language; -0.3 (-4.2 to 3.7; P=0.90) for receptive language; 4.1 (-2.3 to 10.6; P=0.21) for vocabulary checklist; -0.5 (-4.4 to 3.4; P=0.80) for Expressive Vocabulary Test; -0.1 (-1.6 to 1.4; P=0.86) for externalising behaviour problems; and -0.1 (-1.3 to 1.2; P=0. 92) for internalising behaviour problems. CONCLUSION: This community based programme targeting slow to talk toddlers was feasible and acceptable, but little evidence was found that it improved language or behaviour either immediately or at age 3 years. TRIAL REGISTRATION: Current Controlled Trials ISRCTN20953675.

Slight-mild sensorineural hearing loss in children: audiometric, clinical, and risk factor profiles.

OBJECTIVES: Slight or mild hearing loss has been posited as a factor affecting speech, language, learning, and academic outcomes, but the risk factors for slight-mild sensorineural hearing loss (SNHL) have not been ascertained. The two specific aims for this research were (1) to describe the audiometric and clinical characteristics of children identified with slight-mild bilateral SNHL and (2) to compare children with slight-mild SNHL with those with normal hearing (NH) with respect to potential risk factors for congenital or acquired for hearing loss. DESIGN: A cross-sectional cluster sample survey of 6581 children enrolled in years 1 and 5 of Australian elementary school was completed. Children were screened for slight-mild SNHL, defined as a low- and/or high-frequency pure-tone average of 16 to 40 dB HL in the better ear, with air-bone gaps <10 dB. Children who did not pass the screen received air and bone conduction threshold and tympanometry tests to determine the type and degree of hearing loss. The parents of every child who participated in this study completed a questionnaire, before the hearing screening, to ascertain possible risk indicators. The questionnaire included items regarding the family's demographics, hearing status of family members, the presence of risk factors, and parental concern regarding the child's hearing. RESULTS: Fifty-five children with slight-mild SNHL and 5490 with NH were identified. Of the group with SNHL, 39 children had a slight loss (16 to 25 dB HL) and 16 had a mild loss (26 to 40 dB HL). The majority of the losses were bilateral and symmetrical, and the mean pure-tone average for the better ear for all 55 children was 22.4 dB HL (SD, 5.2). The most prevalent risk factor was "neonatal intensive care unit/special care nursery admission," which was reported for 12.5% of the SNHL and 8.4% of the NH group. Reported use of personal stereos was a significant risk factor with an odds ratio of 1.7 (95% confidence interval = 1.0 to 3.0, p = 0.05). The questions relating to parental concern for their child's hearing had low sensitivity (<30%) and very low positive predictive values (<3%) for detecting slight-mild SNHL. CONCLUSIONS: Slight-mild SNHL had a prevalence of 0.88% among the school-aged population sampled, with the majority of these children exhibiting bilateral, symmetrical audiometric configurations. Conventional risk factors for hearing loss were not strongly predictive of slight-mild SNHL nor were parental concerns about the child's hearing ability. The association between slight-mild SNHL and the parent report of personal stereo use suggests that this type of noise exposure may be a risk factor for acquired hearing loss. This seems to be the first documentation of such an association in a large sample of young children.

Slight/mild sensorineural hearing loss in children.

OBJECTIVE: The goal was to determine the prevalence and effects of slight/mild bilateral sensorineural hearing loss among children in elementary school. METHODS: A cross-sectional, cluster-sample survey of 6581 children (response: 85%; grade 1: n = 3367; grade 5: n = 3214) in 89 schools in Melbourne, Australia, was performed. Slight/mild bilateral sensorineural hearing loss was defined as a low-frequency pure-tone average across 0.5, 1, and 2 kHz and/or a high-frequency pure-tone average across 3, 4, and 6 kHz of 16 to 40 dB hearing level in the better ear, with air/bone-conduction gaps of < 10 dB. Parents reported children's health-related quality of life and behavior. Each child with slight/mild bilateral sensorineural hearing loss, matched to 2 normally hearing children (low-frequency pure-tone average and high-frequency pure-tone average of < or = 15 dB hearing level in both ears), completed standardized assessments. Whole-sample comparisons were adjusted for type of school, grade level, and gender, and matched-sample comparisons were adjusted for nonverbal IQ scores. RESULTS: Fifty-five children (0.88%) had slight/mild bilateral sensorineural hearing loss. Children with and without sensorineural hearing loss scored similarly in language (mean: 97.2 vs 99.7), reading (101.1 vs 102.8), behavior (8.4 vs 7.0), and parent- and child-reported child health-related quality of life (77.6 vs 80.0 and 76.1 vs 77.0, respectively), but phonologic short-term memory was poorer (91.0 vs 102.8) in the sensorineural hearing loss group. CONCLUSIONS: The prevalence of slight/mild bilateral sensorineural hearing loss was lower than reported in previous studies. There was no strong evidence that slight/mild bilateral sensorineural hearing loss affects adversely language, reading, behavior, or health-related quality of life in children who are otherwise healthy and of normal intelligence.