Clinical trial NCT03866616: Evaluation Study of the Impact of the New Brain Builders Parenting Class
Official title: Evaluation Study of the Impact of the New Brain Builders Parenting Class Offered at WIC Clinics
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Child Development
Mother-Child Interaction
Lead sponsor: William Marsh Rice University
Sponsor class: OTHER
Collaborators: name: Harris County Department of Public Health
name: City of Houston Department of Health and Human Services WIC offices
name: Episcopal Health Foundation
First posted: 2019-03-07
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this research is to evaluate the effectiveness of the parenting program on increasing positive parent-child interactions and increasing cognitive achievement in children. Overall, this project is intended to benefit women and children and supplement WIC services.

The Brain Builders Parenting Class Evaluation Study Research Questions include the following:

1. Does the program impact child development outcomes such as kindergarten readiness?
2. Does the program increase parental knowledge about the importance of high-quality parent-child interaction for child development?
3. Does the program impact the quality and quantity of the parent-child interactions?

Detailed description: Science demonstrates that the foundation of a person's ability to be innovative, creative, analytical and intellectual is established in the brain during the first few years of life. The brain controls every aspect of human life, from breathing to learning, behaving, adapting and thinking. Because the brain controls all aspects of human life, impaired brain function compromises physical, mental, and emotional health and overall productivity in society. The parent-child or caregiver-child relationship is one of the most important experiences for brain development and cognitive outcomes in young children. This relationship is vital for optimal brain development because of the dependency of neuronal connections on stimulating human interaction. Parental response to their child's verbal or nonverbal cues, frequently called "serve and return", influences whether neural connections are strengthened or eliminated. An example of a positive serve and return scenario is a caregiver or parent's attentive response to a young child's cries through eye contact, acknowledging the child, and meeting the child's need. This type of positive interaction fosters neural connections that are important for communication and social skills.

Many parents do not know or understand the impact their responses have on their child's brain development. While there are many parenting programs that teach parenting skills and behaviors, there were no evidences of any programs that were culturally and economically sensitive to vulnerable families and also educated parents on the brain science as well as equip parents with the skills to be responsive parents Brain Builders Parenting Class will work with both inner city and rural WIC clinics with representative populations of pregnant women and women with children under 1 years old, to provide parenting programs, led by WIC staff focused on brain development.

The study will evaluate the effectiveness of the parenting program in increasing positive parent-child interactions and increasing cognitive achievement in the children. The main goal of this evaluation study is to increase parents' self-efficacy by increasing their knowledge of brain development, improve their skills through observational learning and behavioral capability, provide reinforcement for positive interactions with baby and child, and increase their social support through the group parenting classes and shared experiences. The evaluation study will have two rounds. The first round will take place at recruitment in the WIC Centers. The second round will take place around the time that the child is between 22 and 26 months old. This visit will take place at the WIC clinic.

Eligibility criteria: Inclusion Criteria:

* English-speaking healthy women who have not had a prior live birth and are between their 13th and 22nd week of pregnancy, English-speaking healthy women who are between their 13th and 22nd week of pregnancy and and who have children 6 years or older;
* English-speaking healthy women: First time mothers of 0 to 1-year old children
* English-speaking healthy women: Mothers of 0 to 1-year old children who have children 6 years or older;
* Are at least 18 years old, AND (2) self-identify as non-Hispanic white, Hispanic/Latinx, Asian or black/African American
* Are not planning to move to a location more than 50 miles from the WIC clinic in the first two years after the baby's birth;
* Are not planning to put the baby up for adoption
* Women who agreed to participate in the lottery for the Brain Builder Parenting Class program.
* Women who are pregnant with multiples (i.e. twins, triples, etc) will also be eligible for participation.
* Children of healthy women who are enrolled in the pilot evaluation study
* Children between the ages of 0-12 months at the time of recruitment. -

Exclusion criteria:

* Non-English-speaking women;
* The woman is not between her 13th and 22nd week of pregnancy
* The woman has more than one biological child
* The woman does not participate in the WIC clinic
* The woman is planning to move to a location more than 50 miles from WIC clinic in the two years after the baby's birth;
* The woman is planning to put the baby up for adoption;
* The woman does not agree to participate in the lottery for the Brain Builder Parenting Class program.
* English-speaking healthy women:
* First time mothers of 0 to 1-year old children
* Children of healthy women who are not enrolled in the pilot evaluation study. Children that are not between the ages of 0-12 months at the time of recruitment.

Primary outcomes:
measure: Child Development
timeFrame: Measured at 22 to 26 months of age
measure: Quality of the Language Environment: LENA System
timeFrame: Measured at 22 to 26 months of age
measure: Measurement of the Child's Home Environment
timeFrame: Measured at 22 to 26 months of age
measure: Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO).
timeFrame: Measured 22 to 26 months of age
measure: Quality of the Child Sleep: The Brief Infant Sleep Questionnaire (BISQ)
timeFrame: Measured at 22 to 26 months of age
measure: Parent's beliefs
timeFrame: Measured at baseline and from 22 to 26 months of age
Secondary outcomes:
measure: Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: Measured at baseline
Other outcomes:
Locations:
city: Houston
country: United States
facility: Northeast WIC Center
state: Texas
city: Houston
country: United States
facility: Harris County Public Health Antoine WIC
state: Texas
Study officials:
affiliation: William Marsh Rice University
name: Snejana Nihtianova, PhD
role: PRINCIPAL_INVESTIGATOR
References: