- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05444205
The Pittsburgh Study Early Childhood (TPS-ECC)
The Pittsburgh Study Early Childhood Collaborative
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniel S Shaw, PhD
- Phone Number: 412-624-1836
- Email: danielshaw@pittt.edu
Study Contact Backup
- Name: Chelsea M Weaver Krug, PhD
- Phone Number: 412-624-4020
- Email: chelsea.krug@pitt.edu
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15222
- Recruiting
- Women, Infants, and Children Program
-
Contact:
- Lisa Matt, MS RD
- Phone Number: 412-350-5804
- Email: lisa.matt@alleghenycounty.us
-
Pittsburgh, Pennsylvania, United States, 15208
- Active, not recruiting
- Primary Care Health Services
-
Pittsburgh, Pennsylvania, United States, 15213
- Active, not recruiting
- Children's Hospital of Pittsburgh Primary Care Centers
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Pittsburgh, Pennsylvania, United States, 15213
- Active, not recruiting
- Magee Women's Hospital
-
Pittsburgh, Pennsylvania, United States, 15221
- Active, not recruiting
- Allegheny County Family Centers
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Allegheny County Residency, legal custodian of child
Exclusion Criteria:
- Non-English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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 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.
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.
|
Experimental: 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.
|
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.
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.
|
Experimental: 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.
|
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.
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.
|
Experimental: 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.
|
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 consists of delivering both Video Interaction Project and the Family Check-up packed together as a single intensive intervention.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
4 years
|
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 |
4 years
|
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. |
4 years
|
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. |
4 years
|
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. |
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive parenting skills - PYB
Time Frame: 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. |
4 years
|
Positive parenting skills - PYT
Time Frame: 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. |
4 years
|
Positive parenting skills - PARYC
Time Frame: 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. |
4 years
|
Harsh parenting
Time Frame: 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. |
4 years
|
Parent depressive symptoms
Time Frame: 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. |
4 years
|
Parent anxiety symptoms
Time Frame: 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. |
4 years
|
Parent social support
Time Frame: 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 |
4 years
|
Well-child care
Time Frame: 4 years
|
Change in well-child pediatric visits and receipt of immunizations.
Measured by medical records released by the participant.
|
4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Elizabeth Miller, MD, PhD, University of Pittsburgh
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY19060235
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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