Clinical trial NCT03641092: CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood
Official title: Evaluation of the Impact of the CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parent-Child Relations
Parenting
Child Development
Child Behavior
Keywords: School readiness
Child development
Child behavior
Parenting behavior
CenteringParenting
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Centering Healthcare Institute
name: Overdeck Family foundation
name: Valhalla Foundation
First posted: 2018-08-21
Enrollment: 1200
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Early language assessment at 12 months
timeFrame: 12 months
measure: Early language assessment at 24 months
timeFrame: 24 months
measure: Receptive vocabulary assessment at 3 months
timeFrame: 3 months
measure: Receptive vocabulary assessment at 12 months
timeFrame: 12 months
measure: Receptive vocabulary assessment at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: Parental behavior at 12 months
timeFrame: 12 months
measure: Parental behavior at 24 months
timeFrame: 24 months
Other outcomes:
measure: Child socio-emotional development at 3 months
timeFrame: 3 months
measure: Child socio-emotional development at 12 months
timeFrame: 12 months
measure: Child socio-emotional development at 24 months
timeFrame: 24 months
measure: Parenting Stress at 3 months
timeFrame: 3 months
measure: Parenting Stress at 12 months
timeFrame: 12 months
measure: Parenting Stress at 24 months
timeFrame: 24 months
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Renee Boynton, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References: