CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood

NCT ID: NCT03641092

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-19
• Study Completion Date: 2026-09-30

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).

Detailed Description

Children raised in environments with limited stimulation and lack of exposure to positive interactions are likely to have developmental delays in expressive and receptive language, vocabulary, social skills, behavior-all factors critical for school readiness. Children who enter kindergarten underprepared are more likely to struggle academically and experience lower school achievement, and ultimately impaired opportunities for economic and social mobility as adults.

The CenteringParenting intervention is designed to reduce negative health and developmental outcomes within a model of group routine child health care. This bundled intervention supports healthy parent-child interactions and early learning through education and experiential learning within a group well-child visit model. The intervention reduces social isolation and creates a community of support for caregivers, as well as utilizes a positive parenting approach to empowering parents with knowledge and skills to support optimal child development. The CenteringParenting intervention includes written materials provided at an annual clinical visit, as well as specific training for the facilitators/providers. To date, there is no research evidence of the benefits of the CenteringParenting intervention on school readiness, or improvements in parental behaviors that support optimal developmental milestones and achievement.

Study Design: A multi-site, cluster randomized controlled trial evaluating the impact of the CenteringParenting clinical intervention on kindergarten readiness, as measured by expressive and receptive language and vocabulary at 24 months of age.

Objective Hypothesis: Compared to those receiving standard routine health care, the CenteringParenting intervention will result in improved language development at age 2 years and increased parental behaviors to encourage reading, talking and playing.

Specific Aim 1: In a cluster randomized controlled trial, assess the effectiveness and implementation of the CenteringParenting intervention. Specific Aim 2: Evaluate the fidelity of the implementation of the CenteringParenting intervention. Specific Aim 3: Evaluate caregivers' experience and engagement with the CenteringParenting intervention model and explore the relation between degree of engagement and development stimulating behaviors.

Primary outcomes are: expressive and receptive language and vocabulary based on the MacArthur-Bates Communicative Development Inventory (CDI) and Preschool Language Scale-5 (PLS-5) 5th Edition Parent Questionnaire. The secondary outcome is: parental behavior based on the Stim-Q (a reliable and valid measure of cognitive stimulation provided in the home).

Conditions

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental Clinical Site

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

Group Type: EXPERIMENTAL

CenteringParenting Intervention

Intervention Type: 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.

Comparison Clinical Site

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.

Group Type: ACTIVE_COMPARATOR

Routine Well Child Care

Intervention Type: 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.

Interventions

CenteringParenting Intervention

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.

Intervention Type: BEHAVIORAL

Routine Well Child Care

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centering Healthcare Institute

OTHER

Sponsor Role: collaborator

Overdeck Family foundation

OTHER

Sponsor Role: collaborator

Valhalla Foundation

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renee Boynton, MD, ScD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Renee Boynton, MD, ScD

Role: CONTACT

Phone: 617-414-7477

Email: renee.boyntonjarrett@bmc.org

Clare Viglione, MPH

Role: CONTACT

Phone: 617-352-5264

Email: Clare.Viglione@bmc.org

Facility Contacts

Renee Boynton, MD, ScD

Role: primary

Other Identifiers

H-37893

Identifier Type: -

Identifier Source: org_study_id