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King, T., Rosenberg, L., Fuddy, L., McFarlane, E., Sia, C., & Duggan, A. (2005). Prevalence and early identification of language delays among at-risk three year olds. Journal of Developmental & Behavioral Pediatrics, 26(4), 293–303.

Model(s) Reviewed: Healthy Families America (HFA)®
Manuscript screening details
Screening decision Screening conclusion
Passes screens Eligible for review
Study design details
Rating Design Attrition Baseline equivalence Reassignment Confounding factors
Moderate Randomized controlled trial High Established on race and SES. Baseline equivalence on outcomes not feasible. None None
Study characteristics
Study participants Families were recruited to the study between November 1994 and December 1995. Hawaii Healthy Start Program staff screened the medical records of mothers from one of four Oahu communities delivering children at Kapiolani Maternity Hospital for risk factors for child abuse and neglect. Mothers found to be at risk, or those whose records did not contain sufficient information to screen out, were screened further using Kempe’s Family Stress Checklist; eligible families were those in which either parent scored 25 or greater.  Of the 897 families who were eligible to participate in the study, 730 (81%) agreed to participate and were randomly assigned to the program group (n = 395), the main comparison group (n = 290), or a testing comparison group (n = 45). This study focuses on 304 program group children and 209 comparison group children who had available medical records and developmental testing results at age 3 and whose mothers completed at least one interview. On average, at baseline, mothers were 23.7 years of age (program group) and 22.9 years of age (comparison group). 62% (program group) and 64% (comparison group) of participating families lived below the poverty line. The racial composition of the program sample was 34% native Hawaiian or Pacific Islander, 27% Asian or Filipino, 11% Caucasian, and 29% of unknown primary ethnicity. The comparison group consisted of 33% native Hawaiian or Pacific Islander, 28% Asian or Filipino, 12% Caucasian, and 28% of unknown primary ethnicity.
Setting Six Healthy Start Program sites operated by three community-based organizations in Oahu, Hawaii.
Intervention services Home visiting services were designed to provide three to five years of home visiting, with weekly visits for most or all of the child’s first year of life, and visits of gradually decreasing frequency thereafter depending on family need. Home visitors endeavored to establish trusting relationships with families, help them resolve immediate crises, and help them build on existing strengths to improve their ability to function independently. Visitors helped families develop problem-solving skills, connected them to needed services, and aimed to develop an individual service plan with each family every six months and help the family reach six-month goals. The actual frequency of visits, however, was lower than that specified by the model, with families receiving an average of 13 visits in the child’s first year of life, and 51% of families not actively participating in the program by the time the child was 12 months. Families still active at the end of year 1 received an average of 22 visits in the first year (Duggan et al., 1999).
Comparison conditions The main comparison group was tested annually to measure outcomes. A second “testing” comparison group was evaluated only at year 3 to ascertain the effect of repeated testing on observed outcomes (Duggan, McFarlane, Fuddy, Burrell, Higman, Windham et al., 2004).
Staff characteristics and training Trained paraprofessionals were recruited from the community to conduct the home visits.
Funding sources Maternal and Child Health Bureau (R40 MC 00029, formerly MCJ 240637, and R40 MC 00123, formerly MCJ 240838); The Robert Wood Johnson Foundation (18303); The Annie E. Casey Foundation (94-4041); The David and Lucile Packard Foundation (93-6051, 94-7957, 97-8058, and 98-3448); and the Hawaii State Department of Health (99-29-J). Dr. King’s effort was also supported by a National Research Service Award from the Health Resources and Services Administration, Bureau of Health Professions (5 T32 HP 10004).
Author affiliation None of the study authors are developers of this model.

Findings details

Child development and school readiness
Rating Outcome measure Effect Sample Timing of follow-up Sample size Intervention group Comparison group Group difference Effect size Statistical significance Notes
Moderate PLS-3 Score
FavorableUnfavorable or ambiguousNo Effect
Children with developmental testing results, Hawaii trial Age 3 513 children Adjusted mean = 87.90 Adjusted mean = 87.10 Mean difference = 0.80 Not available Not statistically significant, p ≥ 0.05
Moderate Prevalence of any delays (PLS-3 score ≤ 85)
FavorableUnfavorable or ambiguousNo Effect
Children with developmental testing results, Hawaii trial Age 3 513 children % (adjusted) = 48.00 Adjusted mean % = 49.00 OR = 0.97 Not available Not statistically significant, p ≥ 0.05
Moderate Prevalence of severe delays (PLS-3 score ≤ 70)
FavorableUnfavorable or ambiguousNo Effect
Children with developmental testing results, Hawaii trial Age 3 513 children % (adjusted) = 9.00 Adjusted mean % = 11.00 OR = 0.80 Not available Not statistically significant, p ≥ 0.05

Outcome measure summary

Child development and school readiness
Outcome measure Description of measure Data collection method Properties of measure

PLS-3 score

The PLS assesses communication and language development in young children. The researchers examined the mean PLS score in addition to the prevalence of severe delays (PLS-3 score ≤ 70) and the prevalence of any language delays (PLS-3 score ≤ 85). Child assessment

Not reported by author