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Child DevelopmentTPS-ECCNCT05444205

The Pittsburgh Study Early Childhood

A study testing Text4Baby or Bright by Text Referral, Nurture Program Warm Referral and Video Interaction Project in people with Child Development and Child Language, run by University of Pittsburgh at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages Up to 6 yearsHealthy volunteers can take part
What is being tested?
Text4Baby or Bright by Text Referral, Nurture Program Warm Referral and Video Interaction Project
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,546 participants
Where
5 sitesUnited States
Study dates
2 Jun 2020to 13 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Allegheny County Residency, legal custodian of child

Who cannot join

  • Non-English speaking

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Primary Care Health Services

    Pittsburgh, Pennsylvania, 15208

  • Children's Hospital of Pittsburgh Primary Care Centers

    Pittsburgh, Pennsylvania, 15213

  • Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15213

  • Allegheny County Family Centers

    Pittsburgh, Pennsylvania, 15221

  • Women, Infants, and Children Program

    Pittsburgh, Pennsylvania, 15222

Other trials in United States

About this study

Official title: The Pittsburgh Study Early Childhood Collaborative

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.

Read the 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.

Being tested
Text4Baby or Bright by Text Referral, Nurture Program Warm Referral, Video Interaction Project, Family Check-UP, Smart Beginnings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Text4Baby or Bright by Text ReferralBehavioural

    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 ReferralBehavioural

    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 ProjectBehavioural

    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-UPBehavioural

    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 BeginningsBehavioural

    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 ReferralBehavioural

    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 ReferralBehavioural

    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.

Study groups in NCT05444205
Study groupRoleWhat they receive
Higher resources/lower challengesExperimentalParticipants 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.
Receives: Behavioral: Text4Baby or Bright by Text Referral; Behavioral: Nurture Program Warm Referral; Behavioral: Family Center Warm Referral
Lower Resources/Lower ChallengesExperimentalParticipants 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.
Receives: Behavioral: Nurture Program Warm Referral; Behavioral: Video Interaction Project
Moderate ChallengesExperimentalParticipants 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.
Receives: Behavioral: Video Interaction Project; Behavioral: Family Check-UP
Serious ChallengesExperimentalParticipants 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.
Receives: Behavioral: Family Check-UP; Behavioral: Smart Beginnings; Behavioral: Healthy Families America Warm Referral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 years

  2. 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

    Measured: 4 years

  3. 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.

    Measured: 4 years

  4. 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.

    Measured: 4 years

  5. 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.

    Measured: 4 years

Secondary outcomes (8)

  1. 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.

    Measured: 4 years

  2. 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.

    Measured: 4 years

  3. 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.

    Measured: 4 years

  4. 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.

    Measured: 4 years

  5. 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.

    Measured: 4 years

  6. 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.

    Measured: 4 years

  7. 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

    Measured: 4 years

  8. Well-child care

    Change in well-child pediatric visits and receipt of immunizations. Measured by medical records released by the participant.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start2 Jun 2020
  3. Primary completion30 Jun 2026
  4. Study completion13 Jul 2026

Why it stopped: Supported by university, hospital, and philanthropic foundation funds, the study lost its funding and was prematurely terminated.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Crossover
Model description
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.
Masking
None (open label)
Enrolment
2,546 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05444205
Sponsor's protocol ID
STUDY19060235
Acronym
TPS-ECC
Status last verified
Oct 2026
First submitted
25 Feb 2022
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified IPD will be made public after the trial.

Publications

  • Krug CW, Mendelsohn AL, Wuerth J, Roby E, Shaw DS. The Pittsburgh Study: A Tiered Model to Support Parents during Early Childhood. J Pediatr. 2025 Feb;277:114396. doi: 10.1016/j.jpeds.2024.114396. Epub 2024 Nov 12.

    PubMed 39536860

Questions about this trial

What is this clinical trial studying?

A study testing Text4Baby or Bright by Text Referral, Nurture Program Warm Referral and Video Interaction Project in people with Child Development and Child Language, run by University of Pittsburgh at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Supported by university, hospital, and philanthropic foundation funds, the study lost its funding and was prematurely terminated.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child inhibitory control (time frame: 4 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05444205, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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