CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood

NCT03641092 | Recruiting

• 1 other identifier: H-37893
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

Disparities in health begin in early childhood. Early life experiences influence brain development and have significant implications on future health and developmental outcomes. Low-income children are at greater risk of developmental delays in large part due to a lack of an enriched environment. Disparities in early childhood development increase risk for stunted academic achievement throughout the life course. Primary care is a universal exposure in early childhood and therefore is also a significant entry point for promoting optimal child development. There is a need to provide effective, low-cost, and scalable interventions in primary care to support early childhood development.The CenteringParenting intervention is designed to reduce negative health and developmental outcomes within a model of group routine child health care. To date, there is no evidence of the benefits of the CenteringParenting intervention on school readiness, or improvements in parental behaviors that support optimal developmental milestones and achievement. The intent of this study is to determine the effectiveness of the CenteringParenting intervention on school readiness in early childhood, as measured by language development at 24 months, (in addition to health care utilization, child routine care maintenance, parenting stress, caregiver behaviors and attitudes).

Conditions

Parent-Child Relations; Parenting; Child Development; Child Behavior

Keywords

School readiness; Child development; Child behavior; Parenting behavior; CenteringParenting

Outcome Measures

Primary Outcomes (5)

• Early language assessment at 12 months

  Assess early language (vocabulary, comprehension, production, gestures and grammar) based on the MacArthur Communicative Development Inventories (CDI). The Words and Gestures short form (Level I) is comprised of a 89-word vocabulary checklist with separate columns for comprehension and production, appropriate for children 8-18 months. The score is assessed in the amount of correct answers and measured in percentiles, from \<1th to 100th, depending on the child's age. Administered by research assistant to female guardian.

  12 months

• Early language assessment at 24 months

  Assess early language (vocabulary, comprehension, production, gestures and grammar) based on the MacArthur Communicative Development Inventories (CDI). Two equivalent Words \& Sentences versions (Level IIA and Level IIB) contain a 100-word productive vocabulary checklist and a question about combining words, appropriate for children 16-30 months. The score is assessed in the amount of correct answers and measured in percentiles, from \<1th to 100th, depending on the child's age. Administered by research assistant to female guardian.

  24 months

• Receptive vocabulary assessment at 3 months

  Assess Receptive vocabulary based on the Preschool Language Scale-5 (PLS-5) 5th Edition Parent Questionnaire. The scale accesses: Total language, auditory comprehension, expressive communication standard scores, growth scores, percentile ranks, language age equivalents. PLS-5 scores range anywhere from 40-160 with the mean being 100 and an SD of 15. Higher percentile ranks are correlated with higher the levels of receptive vocabulary. Administered by research assistant to female guardian.

  3 months

• Receptive vocabulary assessment at 12 months

  Assess Receptive vocabulary based on the Preschool Language Scale-5 (PLS-5) 5th Edition Parent Questionnaire. The scale accesses: Total language, auditory comprehension, expressive communication standard scores, growth scores, percentile ranks, language age equivalents. PLS-5 scores range anywhere from 40-160 with the mean being 100 and an SD of 15. Higher percentile ranks are correlated with higher the levels of receptive vocabulary. Administered by research assistant to female guardian.

  12 months

• Receptive vocabulary assessment at 24 months

  Assess Receptive vocabulary based on the Preschool Language Scale-5 (PLS-5) 5th Edition Parent Questionnaire. The scale accesses: Total language, auditory comprehension, expressive communication standard scores, growth scores, percentile ranks, language age equivalents. PLS-5 scores range anywhere from 40-160 with the mean being 100 and an SD of 15. Higher percentile ranks are correlated with higher the levels of receptive vocabulary. Administered by research assistant to female guardian.

  24 months

Secondary Outcomes (2)

• Parental behavior at 12 months

  12 months

• Parental behavior at 24 months

  24 months

Other Outcomes (6)

• Child socio-emotional development at 3 months

  3 months

• Child socio-emotional development at 12 months

  12 months

• Child socio-emotional development at 24 months

  24 months

Study Arms (2)

Experimental Clinical Site

EXPERIMENTAL

5 experimental clinical sites will receive the implementation of CenteringParenting assistance early. This arm will include the CenteringParenting intervention.

Behavioral: CenteringParenting Intervention

Comparison Clinical Site

ACTIVE COMPARATOR

5 comparison clinical sites will receive Routine Well Child Care and CenteringParenting implementation assistance later and serve as control sites. This arm will include the Routine Well Child Care intervention.

Behavioral: Routine Well Child Care

Interventions

CenteringParenting Intervention BEHAVIORAL

The CenteringParenting(CP) intervention includes group well child care visits during the first 24 months of life. Participants receive a journal with child safety, health and development information. The groups are co-led by a practitioner and support staff member. This bundled intervention supports healthy parent-child interactions and early learning through education and experiential learning within the well-child visit.

Experimental Clinical Site

Routine Well Child Care BEHAVIORAL

The Comparison Clinical Sites will receive the Routine Well Child Care standard individual clinical care. This clinic will receive delayed training in the CenteringParenting(CP) intervention approximately 3 months after the completion of recruitment at their study site \[when recruited families will be ineligible for CenteringParenting groups that will start in control sites\]. They will receive anticipatory guidance and handouts that are standard for the clinic.

Comparison Clinical Site

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• For participating practice sites
• Practice provides care to patients who are covered by public insurance and/or uninsured (no minimum threshold: all insurance types eligible)
• Practices have at least 3,000 primary care visits per year
• For parent-child dyad
• Index child age must be 0-3 months
• Parent must be female
• Parent must be 18 years of age and older
• Parent and child must attend one of the 10 study clinical sites
• Parental consent
• Parent must be fluent in English or Spanish

You may not qualify if:

• For participating practice sites
• Does not accept public insurance
• For parent-child dyad
• Child born prior to 34 weeks gestation
• Child with chronic conditions known to affect neurodevelopment
• Child with a positive screen on the Children with Special Healthcare Needs screener

Sponsors & Collaborators

• Boston Medical Center: lead
• Centering Healthcare Institute: collaborator
• Overdeck Family foundation: collaborator
• Valhalla Foundation: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Renee Boynton, MD, ScD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renee Boynton, MD, ScD

CONTACT

617-414-7477; renee.boyntonjarrett@bmc.org

Clare Viglione, MPH

CONTACT

617-352-5264; Clare.Viglione@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: August 21, 2018
• Study Start: February 19, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)