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Clinical Trials/NCT05444205
NCT05444205Active, not recruitingNot Applicable

The Pittsburgh Study Early Childhood Collaborative

University of Pittsburgh10 sites in 1 country24,000 target enrollmentStarted: June 2, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
24,000
Locations
10
Primary Endpoint
Child inhibitory control

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Masking Description

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

Eligibility Criteria

Ages
— to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Allegheny County Residency, legal custodian of child

Exclusion Criteria

  • Non-English speaking

Outcomes

Primary Outcomes

Child inhibitory control

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Positive parenting skills - PYT(4 years)
  • Harsh parenting(4 years)
  • Parent anxiety symptoms(4 years)
  • Positive parenting skills - PARYC(4 years)
  • Parent social support(4 years)
  • Parent depressive symptoms(4 years)
  • Well-child care(4 years)
  • Positive parenting skills - PYB(4 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daniel Shaw

Professor

University of Pittsburgh

Study Sites (10)

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