Evaluation Study of the Impact of the New Brain Builders Parenting Class

NCT ID: NCT03866616

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2019-12-15

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.

Conditions

Child Development; Mother-Child Interaction

Study Design

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

Study Groups

Control (usual care)

Behavioral: This arm receives usual care ("control group") consisting in: WIC participants will attend their usual appointments completed at the WIC clinics.

Group Type: ACTIVE_COMPARATOR

Control (Usual care)

Intervention Type: BEHAVIORAL

This arm receives usual care ("control group") consisting in: WIC participants will attend their usual appointments completed at the WIC clinics.

Intervention (group sessions)

Behavioral: Brain Builders Parenting Class-intervention (BBPC). Participants who are selected via the lottery to participate in the BBPC program will be asked to attend six, 1-hour classes, every other week over a 12 week period of time.

Group Type: EXPERIMENTAL

Brain Builders Parenting Class

Intervention Type: BEHAVIORAL

Brain Builders Parenting Class group sessions goal is to increase parental knowledge of brain development and increase responsive parenting

Interventions

Brain Builders Parenting Class

Brain Builders Parenting Class group sessions goal is to increase parental knowledge of brain development and increase responsive parenting

Intervention Type: BEHAVIORAL

Control (Usual care)

This arm receives usual care ("control group") consisting in: WIC participants will attend their usual appointments completed at the WIC clinics.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harris County Department of Public Health

UNKNOWN

Sponsor Role: collaborator

City of Houston Department of Health and Human Services WIC offices

UNKNOWN

Sponsor Role: collaborator

Episcopal Health Foundation

UNKNOWN

Sponsor Role: collaborator

William Marsh Rice University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Snejana Nihtianova, PhD

Role: PRINCIPAL_INVESTIGATOR

William Marsh Rice University

Locations

Northeast WIC Center

Houston, Texas, United States

Harris County Public Health Antoine WIC

Houston, Texas, United States

Countries

United States

Other Identifiers

2019-216

Identifier Type: -

Identifier Source: org_study_id