Parent-Child RelationsNCT03641092
CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood
A study testing CenteringParenting Intervention and Routine Well Child Care in people with Parent-Child Relations and Parenting, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations, Parenting, Child Development
- What is being tested?
- CenteringParenting Intervention and Routine Well Child Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2019to Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of the CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood
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).
Read the 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
- Being tested
- CenteringParenting Intervention, Routine Well Child Care
- Keywords
- School readiness, Child development, Child behavior, Parenting behavior, CenteringParenting
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenteringParenting InterventionBehavioural
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.
Routine Well Child CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Clinical Site | Experimental | 5 experimental clinical sites will receive the implementation of CenteringParenting assistance early. This arm will include the CenteringParenting intervention. Receives: 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. Receives: Behavioral: Routine Well Child Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Secondary outcomes (2)
Parental behavior at 12 months
StimQ is an interview-based instrument to assess the family cognitive environment. StimQ-Infant has four scale scores, which add up to the total StimQ Score. ALM Scale ranges 0-6, READING Scale Score ranges 0-15, PIDA Scale Score ranges 0-7, and PVR Scale Score ranges 0-11. The highest total StimQ Score is 39 and the lowest is 0. Higher StimQ scores are correlated with better parental behavior. StimQ-Infant will be done up to 15 months. Administered by research assistant to female guardian.
Measured: 12 months
Parental behavior at 24 months
StimQ is an interview-based instrument to assess the family cognitive environment. StimQ-toddler has four scale scores, which add up to the total StimQ Score. ALM Scale ranges 0-7, READING Scale Score ranges 0-18, PIDA Scale Score ranges 0-10, and PVR Scale Score ranges 0-4. The highest total StimQ Score is 39 and the lowest is 0.Higher StimQ scores are correlated with better parental behavior. StimQ-Toddler will be done up to 27 months. Administered by research assistant to female guardian.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start19 Feb 2019
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centering Healthcare Institute, Overdeck Family foundation, Valhalla Foundation
- Responsible party
- Sponsor
- Investigators
- Renee Boynton, MD, ScD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641092
- Sponsor's protocol ID
- H-37893
- Status last verified
- Oct 2026
- First submitted
- 4 Jul 2018
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No