Child DevelopmentNCT03866616
Evaluation Study of the Impact of the New Brain Builders Parenting Class
A study testing Brain Builders Parenting Class in people with Child Development and Mother-Child Interaction, run by William Marsh Rice University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Development, Mother-Child Interaction
- What is being tested?
- Brain Builders Parenting Class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jun 2019to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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. -
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northeast WIC Center
Houston, Texas, 77016
Harris County Public Health Antoine WIC
Houston, Texas, 77091
About this study
Official title: Evaluation Study of the Impact of the New Brain Builders Parenting Class Offered at WIC Clinics
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:
- Does the program impact child development outcomes such as kindergarten readiness?
- Does the program increase parental knowledge about the importance of high-quality parent-child interaction for child development?
- Does the program impact the quality and quantity of the parent-child interactions?
Read the 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
- Being tested
- Brain Builders Parenting Class, Control (Usual care)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Builders Parenting ClassBehavioural
Brain Builders Parenting Class group sessions goal is to increase parental knowledge of brain development and increase responsive parenting
Control (Usual care)Behavioural
This arm receives usual care ("control group") consisting in: WIC participants will attend their usual appointments completed at the WIC clinics.
| Study group | Role | What they receive |
|---|---|---|
| Control (usual care) | Active comparator | Behavioral: This arm receives usual care ("control group") consisting in: WIC participants will attend their usual appointments completed at the WIC clinics. Receives: Behavioral: Control (Usual care) |
| Intervention (group sessions) | Experimental | 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. Receives: Behavioral: Brain Builders Parenting Class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Development
The child development will be assessed by using the Caregiver Reported Early Development Index (CREDI). The CREDI measures five dimension of child development: Motor development, Language development; Socioemotional development; Cognitive development; and Mental health. The CREDI was designed to serve as a population-level measure of early childhood development for children from birth to age three. As the name suggests, the CREDI exclusively relies on caregiver reports, and thus primarily focuses on milestones and behaviors that are easy for caregivers to understand, observe and describe.
Measured: Measured at 22 to 26 months of age
Quality of the Language Environment: LENA System
The quality of the language environment at home will be measured by using the LENA System (LENA). LENA is an integrated processing and cloud-based software package that enables researchers to collect, manage, and analyze multiple recordings of children ages 2 months to 48 months.LENA device estimates adult words spoken to and around the key child, adult-child conversational interactions, child vocalizations, and language from TV and/or electronics
Measured: Measured at 22 to 26 months of age
Measurement of the Child's Home Environment
The StimQ instrument is a 39-point scale for measuring cognitive stimulation in the homes of children. It includes four sub scales: Availability of Learning Materials (ALM); Reading Scale; Parental Involvement in the Developmental Advance (PIDA); and Parental Verbal Responsivity (PVR). The ALM describes the type of learning materials available to a child. The Read Scale measures the number of books in the home and the amount of days spent reading to the child. The PIDA is scored by the number of 'Yes' responses to ten questions regarding parental involvement in child development. The PVR is scored by calculating the total number of 'Yes' responses to four questions regarding parental verbal responsibility. Higher values are associated with a better outcome since a higher value indicates the presence of more learning materials in the home. Subscales are combined by summing all the subscale scores to get the total StimQ score.
Measured: Measured at 22 to 26 months of age
Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO).
This scale measures the presence and absence of 29 developmentally supportive parenting behaviors across the entirety of a 10 minute, video recorded interaction. The PICCOLO scale is divided into four subcategories: affection, responsiveness, encouragement, and teaching. Each subcategory has approximately 7-8 parenting behaviors that a PICCOLO practitioner would observe. Each category's behaviors are scored on a scale from 0-2 where parents receive (0) if none of the behavior, (1) if some of the behavior, (2) if lots of the behavior. Higher values are associated with better outcomes since high values indicate a high amount of affection, responsiveness, encouragement, and teaching, which are behaviors linked to healthy cognitive development in children
Measured: Measured 22 to 26 months of age
Quality of the Child Sleep: The Brief Infant Sleep Questionnaire (BISQ)
The Brief Infant Sleep Questionnaire (BISQ) was developed on the basis of a review of the infant sleep literature in search of meaningful variables, particularly clinical studies based on the use of subjective and objective infant sleep measures. The questionnaire variables included 1) nocturnal sleep duration; 2) daytime sleep duration); 3) number of night wakings; 4) duration of wakefulness during the night hours; and 5) nocturnal sleep-onset. The criteria used to define poor sleepers on the basis of the BISQ measures are as follows: 1) the child wakes > 3 times per night; 2) nocturnal wakefulness period is > 1 hour; or 3) the total sleep time is < 9 hours. Soothing techniques and the location of sleep are also evaluated and seem to play important roles in infant sleep. Infants who fall asleep alone in the crib and sleep in a crib in a separate room are more likely to sleep through the night, with fewer night wakings
Measured: Measured at 22 to 26 months of age
Parent's beliefs
The parent's beliefs questionnaire measures the impact of parental investments in the child (for example, reading to the child) on child development.
Measured: Measured at baseline and from 22 to 26 months of age
Secondary outcomes (1)
Center for Epidemiological Studies Depression Scale (CES-D)
Maternal depressive symptomatology measured by the Center for Epidemiological Studies Depression Scale (CES-D)The score is the sum of the 20 questions. Each question has a total of four responses to choose from and each response is scored from 0-3 respectively.Possible range is 0-60. A score of 16 points or more is considered depressed. High values are considered a worse outcome since a score of 16 points or higher is indicative of depression.
Measured: Measured at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start24 Jun 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Why it stopped: The PI discontinued the evaluation study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Marsh Rice University
- Sponsor type
- University, hospital or other
- Collaborators
- Harris County Department of Public Health, City of Houston Department of Health and Human Services WIC offices, Episcopal Health Foundation
- Responsible party
- Sponsor
- Investigators
- Snejana Nihtianova, PhD, Principal investigator, William Marsh Rice University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866616
- Sponsor's protocol ID
- 2019-216
- Status last verified
- Aug 2020
- First submitted
- 11 Feb 2019
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Study of the Impact of the New Brain Builders Parenting Class Offered at WIC Clinics
- ClinicalTrials.gov ID
- NCT03866616
- Acronym / sponsor ID
- 2019-216
- Conditions
- Child Development, Mother-Child Interaction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI discontinued the evaluation study.
- Enrolment
- 145 participants (actual)
- Lead sponsor
- William Marsh Rice UniversityUniversity, hospital or other
- Collaborators
- Harris County Department of Public Health, City of Houston Department of Health and Human Services WIC offices, Episcopal Health Foundation
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the program impact child development outcomes such as kindergarten readiness?
- Does the program increase parental knowledge about the importance of high-quality parent-child interaction for child development?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (usual care) | Active comparator | Behavioral: 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. |
| Intervention (group sessions) | Experimental | Behavioral: Brain Builders Parenting ClassBehavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Builders Parenting ClassBrain Builders Parenting Class group sessions goal is to increase parental knowledge of brain development and increase responsive parenting | Behavioural | Intervention (group sessions) |
| Control (Usual care)This arm receives usual care ("control group") consisting in: WIC participants will attend their usual appointments completed at the WIC clinics. | Behavioural | Control (usual care) |
Primary outcome
Child Development
Time frame: Measured at 22 to 26 months of age
The child development will be assessed by using the Caregiver Reported Early Development Index (CREDI). The CREDI measures five dimension of child development: Motor development, Language development; Socioemotional development; Cognitive development; and Mental health. The CREDI was designed to serve as a population-level measure of early childhood development for children from birth to age three. As the name suggests, the CREDI exclusively relies on caregiver reports, and thus primarily focuses on milestones and behaviors that are easy for caregivers to understand, observe and describe.
Quality of the Language Environment: LENA System
Time frame: Measured at 22 to 26 months of age
The quality of the language environment at home will be measured by using the LENA System (LENA). LENA is an integrated processing and cloud-based software package that enables researchers to collect, manage, and analyze multiple recordings of children ages 2 months to 48 months.LENA device estimates adult words spoken to and around the key child, adult-child conversational interactions, child vocalizations, and language from TV and/or electronics
Measurement of the Child's Home Environment
Time frame: Measured at 22 to 26 months of age
The StimQ instrument is a 39-point scale for measuring cognitive stimulation in the homes of children. It includes four sub scales: Availability of Learning Materials (ALM); Reading Scale; Parental Involvement in the Developmental Advance (PIDA); and Parental Verbal Responsivity (PVR). The ALM describes the type of learning materials available to a child. The Read Scale measures the number of books in the home and the amount of days spent reading to the child. The PIDA is scored by the number of 'Yes' responses to ten questions regarding parental involvement in child development. The PVR is scored by calculating the total number of 'Yes' responses to four questions regarding parental verbal responsibility. Higher values are associated with a better outcome since a higher value indicates the presence of more learning materials in the home. Subscales are combined by summing all the subscale scores to get the total StimQ score.
Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO).
Time frame: Measured 22 to 26 months of age
This scale measures the presence and absence of 29 developmentally supportive parenting behaviors across the entirety of a 10 minute, video recorded interaction. The PICCOLO scale is divided into four subcategories: affection, responsiveness, encouragement, and teaching. Each subcategory has approximately 7-8 parenting behaviors that a PICCOLO practitioner would observe. Each category's behaviors are scored on a scale from 0-2 where parents receive (0) if none of the behavior, (1) if some of the behavior, (2) if lots of the behavior. Higher values are associated with better outcomes since high values indicate a high amount of affection, responsiveness, encouragement, and teaching, which are behaviors linked to healthy cognitive development in children
Quality of the Child Sleep: The Brief Infant Sleep Questionnaire (BISQ)
Time frame: Measured at 22 to 26 months of age
The Brief Infant Sleep Questionnaire (BISQ) was developed on the basis of a review of the infant sleep literature in search of meaningful variables, particularly clinical studies based on the use of subjective and objective infant sleep measures. The questionnaire variables included 1) nocturnal sleep duration; 2) daytime sleep duration); 3) number of night wakings; 4) duration of wakefulness during the night hours; and 5) nocturnal sleep-onset. The criteria used to define poor sleepers on the basis of the BISQ measures are as follows: 1) the child wakes > 3 times per night; 2) nocturnal wakefulness period is > 1 hour; or 3) the total sleep time is < 9 hours. Soothing techniques and the location of sleep are also evaluated and seem to play important roles in infant sleep. Infants who fall asleep alone in the crib and sleep in a crib in a separate room are more likely to sleep through the night, with fewer night wakings
Parent's beliefs
Time frame: Measured at baseline and from 22 to 26 months of age
The parent's beliefs questionnaire measures the impact of parental investments in the child (for example, reading to the child) on child development.
1 secondary outcome
Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: Measured at baseline
Results and safety
The study was stopped early (reason given: The PI discontinued the evaluation study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Snejana Nihtianova, PhD principal investigator
William Marsh Rice University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Builders Parenting Class in people with Child Development and Mother-Child Interaction, run by William Marsh Rice University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The PI discontinued the evaluation study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Development (time frame: Measured at 22 to 26 months of age). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.