The Pittsburgh Study Early Childhood

Not Applicable

Recruiting

• Conditions: Parent Child Abuse; Child Behavior Problem; Child Development; Parenting; Child Language
• Interventions: Behavioral: Text4Baby or Bright by Text Referral; Behavioral: Video Interaction Project; Behavioral: Family Check-UP; Behavioral: Nurture Program Warm Referral; Behavioral: Smart Beginnings; Behavioral: Family Center Warm Referral; Behavioral: Healthy Families America Warm Referral

• Registration Number: NCT05444205
• Lead Sponsor: University of Pittsburgh

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-06-02
• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-07-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2030-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24000

Inclusion Criteria

• Allegheny County Residency, legal custodian of child

Exclusion Criteria

• Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Higher resources/lower challenges	Nurture Program Warm Referral	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.
Lower Resources/Lower Challenges	Nurture Program Warm Referral	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.
Higher resources/lower challenges	Text4Baby or Bright by Text Referral	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.
Moderate Challenges	Video Interaction Project	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.
Serious Challenges	Family Check-UP	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.
Serious Challenges	Smart Beginnings	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.
Higher resources/lower challenges	Family Center Warm Referral	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.
Serious Challenges	Healthy Families America Warm Referral	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.
Lower Resources/Lower Challenges	Video Interaction Project	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.
Moderate Challenges	Family Check-UP	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.

Primary Outcome Measures

Name	Time	Method
Child inhibitory control	4 years	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.
Parent Reading Behaviors - Infancy	4 years	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
Socioemotional adjustment - ITSEA	4 years	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.
Socioemotional adjustment - BITSEA	4 years	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.
Socioemotional adjustment - CBCL	4 years	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.

Secondary Outcome Measures

Name	Time	Method
Positive parenting skills - PYT	4 years	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.
Harsh parenting	4 years	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.
Parent anxiety symptoms	4 years	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.
Positive parenting skills - PARYC	4 years	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.
Parent social support	4 years	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
Parent depressive symptoms	4 years	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.
Well-child care	4 years	Change in well-child pediatric visits and receipt of immunizations. Measured by medical records released by the participant.
Positive parenting skills - PYB	4 years	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.

Trial Locations

Locations (5)

Primary Care Health Services; 🇺🇸 Pittsburgh, Pennsylvania, United States

Children's Hospital of Pittsburgh Primary Care Centers; 🇺🇸 Pittsburgh, Pennsylvania, United States

Magee Women's Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Allegheny County Family Centers; 🇺🇸 Pittsburgh, Pennsylvania, United States

Women, Infants, and Children Program; 🇺🇸 Pittsburgh, Pennsylvania, United States