The Pittsburgh Study Early Childhood

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-02

Study Completion Date

2031-12-31

Brief Summary

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The Early Childhood Collaborative of The Pittsburgh Study is a community-partnered, county-wide implementation of programs for children and families from birth through formal school entry to address real-world challenges that exist in providing effective preventive interventions for families with young children, particularly low-income families.

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Detailed Description

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The Early Childhood Collaborative of The Pittsburgh Study is a community-partnered, county-wide implementation of programs for children and families from birth through formal school entry to address real-world challenges that exist in providing effective preventive interventions for families with young children, particularly low-income families. Specifically, The Early Childhood Collaborative seeks to increase engagement (uptake and retention) in evidence-based interventions by (1) initially assessing families' resources and challenges, (2) offering families a menu of intervention options tailored to their resources/needs, and (3) providing these services at multiple locations to optimize accessibility. The Early Childhood Collaborative involves population-level utilization of multiple platforms that families, particularly families at greater risk for health disparities, typically use, including health care (birthing hospitals, pediatric care, federally qualified health centers), Women, Infants, and Children nutritional clinics, and family centers. The Early Childhood Collaborative will locate services in these platforms and at family's homes. The Early Childhood Collaborative focuses on child thriving and flourishing as key outcomes of interest, and community strengths as key drivers of change. To promote sustainability, investigators include representatives from the Departments of Human Services and Health who are responsible for funding and implementing home visiting programs in the greater Pittsburgh community, with the goal of generating infrastructures and capacity in existing community agencies for providing evidence-based behavioral health care.

Conditions

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Child Development Child Language Child Behavior Problem Parenting Parent Child Abuse

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

The Early Childhood Collaborative is an implementation study and therefore, all participants are offered intervention. An innovative aspect of the study is supporting parent choice of intervention. Participants are given a choice of interventions based on a tiered model, and they can also decline to engage in programs and continue in follow-up.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

The Early Childhood Collaborative is an implementation study and therefore, all participants are offered intervention and there in so masking.

Study Groups

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Higher resources/lower challenges

Participants are assigned to this arm based on results of a brief screen; self-reports indicated that they did not posses any measured risk factors. Participants are provided with a choice of the following preventive interventions: Text4Baby/Bright by Text (depending on child age), Nurture Program, and/or Family Centers.

Group Type EXPERIMENTAL

Text4Baby or Bright by Text Referral

Intervention Type BEHAVIORAL

Passive texting programs where participants receive free text messages on topics such as child development and parenting tips three times per week. Text4Baby serves parents of children under one year. Bright by Text serves parents of children under eight years of age.

Nurture Program Warm Referral

Intervention Type BEHAVIORAL

Nurture Program is a nonprofit organization that promotes healthy development in young children by pairing moms with experienced and knowledgeable mentors who use text messaging to answer questions and provide helpful information, while offering support and encouragement throughout the child's first few years of life.

Family Center Warm Referral

Intervention Type BEHAVIORAL

There are 27 Family Centers across Allegheny County provide services to families of young children 5 and under. These centers focus on three primary activities: 1. enhancing child development; 2. facilitating parent education, and 3. ensuring parents are supported and connected.

Lower Resources/Lower Challenges

Participants are assigned to this arm based on results of a brief screen; self-reports indicated that they were low-income, a teen parent, their newborn had health challenges (more than five weeks premature or a neonatal intensive care unit stay of longer than 4 weeks, or they reported mild parenting challenges. They did not endorse any more serious measured risk factors. Participants are provided with a choice of the following preventive interventions: Nurture Program and/or Video Interaction Project.

Group Type EXPERIMENTAL

Nurture Program Warm Referral

Intervention Type BEHAVIORAL

Nurture Program is a nonprofit organization that promotes healthy development in young children by pairing moms with experienced and knowledgeable mentors who use text messaging to answer questions and provide helpful information, while offering support and encouragement throughout the child's first few years of life.

Video Interaction Project

Intervention Type BEHAVIORAL

The Video Interaction Project is a program to support parents and their young children. Video Interaction Project is typically offered at a convenient location, such as a pediatric clinic. Parents are observed and videotaped for 3 to 5 minutes while interaction with their child. The Video Interaction Project coach then watches the video with the parent and talks about their interaction, highlighting how best to support the child's growth and language development.

Moderate Challenges

Participants are assigned to this arm based on results of a brief screen; self-reports indicated that they had a history of mental health problems, low social support, or moderate parenting challenges. They did not endorse any more serious measured risk factors. Participants are provided with a choice of the following preventive interventions: Nurture Program and/or Video Interaction Project.

Group Type EXPERIMENTAL

Video Interaction Project

Intervention Type BEHAVIORAL

The Video Interaction Project is a program to support parents and their young children. Video Interaction Project is typically offered at a convenient location, such as a pediatric clinic. Parents are observed and videotaped for 3 to 5 minutes while interaction with their child. The Video Interaction Project coach then watches the video with the parent and talks about their interaction, highlighting how best to support the child's growth and language development.

Family Check-UP

Intervention Type BEHAVIORAL

The Family Check-Up is brief, taking place over the course of three sessions, each about an hour long. A Family Check-Up family coach will spend time getting to know the family during an "Initial Interview." Second, parents complete questionnaires that assess child and family adjustment, relationships, and other areas that influence children and families. The assessment includes videotaped family interaction tasks, where parents take part in activities with their child like playing together with toys and puzzles. Third, the Feedback session consists of sharing feedback - including strengths and challenges - about child and family well-being based on survey responses and video clips. Parents are invited to set goals for their family to support and maintain strengths and address areas of concern. Parents are paid 25 dollars after the Feedback Session. Parents have the option to continue meeting with the family coach to support the child's development and improve parental well-being.

Serious Challenges

Participants are assigned to this arm based on results of a brief screen; self-reports indicated that they had a histories of involvement with child welfare, incarceration, opioid use disorder, recent homelessness, or that their child is displaying serious behavior problems. Participants are provided with a choice of the following preventive interventions: Smart Beginnings, Family Check-Up or if the child was less than two weeks old, Healthy Families America.

Group Type EXPERIMENTAL

Family Check-UP

Intervention Type BEHAVIORAL

The Family Check-Up is brief, taking place over the course of three sessions, each about an hour long. A Family Check-Up family coach will spend time getting to know the family during an "Initial Interview." Second, parents complete questionnaires that assess child and family adjustment, relationships, and other areas that influence children and families. The assessment includes videotaped family interaction tasks, where parents take part in activities with their child like playing together with toys and puzzles. Third, the Feedback session consists of sharing feedback - including strengths and challenges - about child and family well-being based on survey responses and video clips. Parents are invited to set goals for their family to support and maintain strengths and address areas of concern. Parents are paid 25 dollars after the Feedback Session. Parents have the option to continue meeting with the family coach to support the child's development and improve parental well-being.

Smart Beginnings

Intervention Type BEHAVIORAL

Smart Beginnings consists of delivering both Video Interaction Project and the Family Check-up packed together as a single intensive intervention.

Healthy Families America Warm Referral

Intervention Type BEHAVIORAL

As part of Healthy Families America, professionally trained Nurse Home Visitors provide information during weekly home visits so that parents can provide the best for your new baby. Topics addressed are ways to keep the baby safe, how to take care of the baby, and activities parents can enjoy with their babies.

Interventions

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Text4Baby or Bright by Text Referral

Passive texting programs where participants receive free text messages on topics such as child development and parenting tips three times per week. Text4Baby serves parents of children under one year. Bright by Text serves parents of children under eight years of age.

Intervention Type BEHAVIORAL

Nurture Program Warm Referral

Nurture Program is a nonprofit organization that promotes healthy development in young children by pairing moms with experienced and knowledgeable mentors who use text messaging to answer questions and provide helpful information, while offering support and encouragement throughout the child's first few years of life.

Intervention Type BEHAVIORAL

Video Interaction Project

The Video Interaction Project is a program to support parents and their young children. Video Interaction Project is typically offered at a convenient location, such as a pediatric clinic. Parents are observed and videotaped for 3 to 5 minutes while interaction with their child. The Video Interaction Project coach then watches the video with the parent and talks about their interaction, highlighting how best to support the child's growth and language development.

Intervention Type BEHAVIORAL

Family Check-UP

The Family Check-Up is brief, taking place over the course of three sessions, each about an hour long. A Family Check-Up family coach will spend time getting to know the family during an "Initial Interview." Second, parents complete questionnaires that assess child and family adjustment, relationships, and other areas that influence children and families. The assessment includes videotaped family interaction tasks, where parents take part in activities with their child like playing together with toys and puzzles. Third, the Feedback session consists of sharing feedback - including strengths and challenges - about child and family well-being based on survey responses and video clips. Parents are invited to set goals for their family to support and maintain strengths and address areas of concern. Parents are paid 25 dollars after the Feedback Session. Parents have the option to continue meeting with the family coach to support the child's development and improve parental well-being.

Intervention Type BEHAVIORAL

Smart Beginnings

Smart Beginnings consists of delivering both Video Interaction Project and the Family Check-up packed together as a single intensive intervention.

Intervention Type BEHAVIORAL

Healthy Families America Warm Referral

As part of Healthy Families America, professionally trained Nurse Home Visitors provide information during weekly home visits so that parents can provide the best for your new baby. Topics addressed are ways to keep the baby safe, how to take care of the baby, and activities parents can enjoy with their babies.

Intervention Type BEHAVIORAL

Family Center Warm Referral

There are 27 Family Centers across Allegheny County provide services to families of young children 5 and under. These centers focus on three primary activities: 1. enhancing child development; 2. facilitating parent education, and 3. ensuring parents are supported and connected.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Allegheny County Residency, legal custodian of child

Exclusion Criteria

* Non-English speaking

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Daniel Shaw

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Miller, MD, PhD

Role: STUDY_DIRECTOR

University of Pittsburgh

Locations

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