The Pittsburgh Study Early Childhood

Child Development Clinical Trial

— TPS-ECC  

Official title:

The Pittsburgh Study Early Childhood Collaborative

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05444205
• Other study ID #: STUDY19060235
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2020
• Est. completion date: May 2025

Study information

• Verified date: July 2023
• Source: University of Pittsburgh
• Contact: Daniel S Shaw, PhD
• Phone: 412-624-1836
• Email: danielshaw[@]pittt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24000
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Years

Eligibility

Inclusion Criteria:

• Allegheny County Residency, legal custodian of child

Exclusion Criteria:

• Non-English speaking

Related Conditions & MeSH terms

• Child Behavior Problem
• Child Development
• Child Language
• Parent Child Abuse
• Parenting
• Problem Behavior

Intervention

Behavioral:
• 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.
• 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.
• 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.
• 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.
• Smart Beginnings
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
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.
• 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.

Locations

Country	Name	City	State
United States	Allegheny County Family Centers	Pittsburgh	Pennsylvania
United States	Children's Hospital of Pittsburgh Primary Care Centers	Pittsburgh	Pennsylvania
United States	Magee Women's Hospital	Pittsburgh	Pennsylvania
United States	Primary Care Health Services	Pittsburgh	Pennsylvania
United States	Women, Infants, and Children Program	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pittsburgh	Heinz Endowments, The Grable Foundation, The Shear Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child inhibitory control	Change in inhibitory control as measured using the 13-item Inhibitory Control scale of the Children's Behavior Questionnaire. Mean scores will be calculated with a possible range of 0-7 (higher scores indicate greater inhibitory control).; Citation: Rothbart, M. K., Ahadi, S. A., Hershey, K. L. & Fisher, P. (2001). Investigations of temperament at 3-7 years: The Children's Behavior Questionnaire. Child Development, 72(5), 1394-1408.	4 years
Primary	Parent Reading Behaviors - Infancy	Change in parent reading behaviors as measured using the StimQ self-report. We will use the 15-item reading factor. Scores used for outcome will be determined by our collaborator (and scale developer) Dr. Alan Mendelsohn and his research team at NYU.; Citations: StimQ2-Infant©2016. NYU School of Medicine Alan L. Mendelsohn MD, Carolyn B. Cates PhD, Matthew Johnson, PhD, Adriana Weisleder PhD, Benard Dreyer MD	4 years
Primary	Socioemotional adjustment - ITSEA	Change in infant and toddler problem behaviors and socioemotional adjustment: Measured by the The infant-toddler social and emotional assessment (ITSEA). We will use the 14-item negative emotionality factor. Items are measured on a 3-point likert-type scale. A sum score will be calculated, with a possible range of 0-28 (higher scores indicate greater problems).; Citations: Carter, A. S., Briggs-Gowan, M. J., Jones, S. M., & Little, T. D. (2003). The infant-toddler social and emotional assessment (ITSEA): Factor structure, reliability, and validity. Journal of abnormal child psychology, 31(5), 495-514.	4 years
Primary	Socioemotional adjustment - BITSEA	Change in infant and toddler problem behaviors: Measured by a subset of 28 items derived from the Brief infant-toddler social and emotional assessment (BITSEA) Total Problems scale. Items are measured on a 3-point likert-type scale. A sum score will be calculated, with a possible range of 0-56 (higher scores indicate greater problems).; Citation: Briggs-Gowan, M. J. & Carter, A.S. (2006). BITSEA : Brief infant-toddler social and emotional assessment. San Antonio, TX: Pearson 2006.	4 years
Primary	Socioemotional adjustment - CBCL	Change in child problem behaviors and socioemotional adjustment: Measured by the Child Behavior Checklist (CBCL). We will use 60 items that comprise the Externalizing and Internalizing broadband factors. Items are measured on a 3-point Likert-type scale. A raw sum score will be calculated for each factor, with a possible range of 0-48 for Externalizing problems and 0-72 for Internalizing problems (higher scores indicate greater problems). We will also calculate t-scores for both scales.; Citation: Achenbach, T. M. (2009). The Achenbach System of Empirically Based Assessment (ASEBA): Development, Findings, Theory, and Applications. Burlington, VT: University of Vermont Research Center for Children, Youth, & Families.	4 years
Secondary	Positive parenting skills - PYB	Change in proactive and positive parenting strategies for parents of infants as measured by Parenting Your Baby (adapted from the Parenting Young Children measure cited below). The measure is comprised of an 8-item positive/supportive parenting score and a 5 item proactive parenting score. Mean scores will be calculated with a possible range of 1-7. Higher scores indicated positive parenting skills.; Citation: McEachern, A.D., Dishion T.D., Weaver, C.M., Shaw, D.S., Wilson, M N. & Gardner, F. (2011). Parenting Young Children (PARYC): Validation of a self-report parenting measure. Journal of Child and Family Studies, 1-14.	4 years
Secondary	Positive parenting skills - PYT	Change in proactive and positive parenting strategies for parents of toddlers as measured by Parenting Your Toddler (adapted from the Parenting Young Children measure cited below). The measure is comprised of a 7-item positive/supportive parenting score, a 7-item proactive parenting score, and 7-items limit setting score. Mean scores will be calculated with a possible range of 1-7. Higher scores indicate positive parenting skills.; Parenting Young Children. Citation: McEachern, A.D., Dishion T.D., Weaver, C.M., Shaw, D.S., Wilson, M N. & Gardner, F. (2011). Parenting Young Children (PARYC): Validation of a self-report parenting measure. Journal of Child and Family Studies, 1-14.	4 years
Secondary	Positive parenting skills - PARYC	Change in proactive and positive parenting strategies as measured by Parenting Young Children. The measure is comprised of a 7-item positive/supportive parenting score, a 7-item proactive parenting score, and 7-items limit setting score. Mean scores will be calculated with a possible range of 1-7. Higher scores indicate positive parenting skills.; Citation: McEachern, A.D., Dishion T.D., Weaver, C.M., Shaw, D.S., Wilson, M N. & Gardner, F. (2011). Parenting Young Children (PARYC): Validation of a self-report parenting measure. Journal of Child and Family Studies, 1-14.	4 years
Secondary	Harsh parenting	Change in harsh parenting strategies as measured by the 5-item Harsh Parenting Scale. Items are measured on a 6-point Likert-type scale. A sum score will be calculated, with a possible range of 5-30. Higher scores indicate harsher parenting.; Citation: Socolar, R. R. S. & Stein, R. E. K. (1995). Spanking Infants and Toddlers: Maternal Belief and Practice. Pediatrics, 95, 105-111.	4 years
Secondary	Parent depressive symptoms	Change in depressive symptoms as measured by the 20-item Centers for Epidemiological Studies-Depression (CES-D). Items are measured on a 4-point Likert-type scale. A sum score will be calculated, with a possible range of 0-60. Higher scores indicate higher levels of depressive symptoms. Note this measure has a clinical cut-off of 16 meaning that scores greater than or equal to 16 indicate clinically significant levels of depression.; Citation: Radloff LS. The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement. 1977;1:385-401.	4 years
Secondary	Parent anxiety symptoms	Change in parent anxiety symptoms as measured by the GAD-7. Items are measured on a 4-point Likert-type scale. A sum score will be calculated, with a possible range of 0-21. Higher scores indicate higher levels of anxiety symptoms.; Citation: Spitzer, R.L., Kroenke, K., Williams, J.B.W., Lowe, B. (2006). A brief measure for assessing generalized anxiety disorder. Archives of Internal Medicine,166,1092-1097.	4 years
Secondary	Parent social support	Change in social support as measured by the 3-item social support subscale of the Comprehensive Inventory of Thriving. Items are measured on a 5-point Likert-type scale. A sum score will be calculated, with a possible range of 3-15. Higher scores indicate greater social support.; Citation: Su, R., Tay, L., & Diener, E. (2014). The development and validation of Comprehensive Inventory of Thriving (CIT) and Brief Inventory of Thriving (BIT). Applied Psychology: Health and Well-Being. Published online before print. doi: 10.1111/aphw.12027	4 years
Secondary	Well-child care	Change in well-child pediatric visits and receipt of immunizations. Measured by medical records released by the participant.	4 years

External Links

•   The Pittsburgh Study website