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Early Childhood Support Programs for Child Development (TPS-ECC Trial)
N/A
Recruiting
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
TPS-ECC Trial Summary
This trial is testing different programs to help low-income families with young children in Pittsburgh.
Who is the study for?
This trial is for legal custodians of young children living in Allegheny County. It's aimed at helping families, especially those with low income, by providing preventive interventions from birth until school starts. Participants must speak English or Spanish to join.Check my eligibility
What is being tested?
The study tests various programs like Family Check-UP and the Nurture Program, which are designed to improve parenting skills and child development. Other interventions include educational text messages and referrals to family support services.See study design
What are the potential side effects?
Since this trial involves educational and supportive interventions rather than medical treatments, traditional side effects are not applicable. However, participants may experience changes in family dynamics or stress levels due to new routines.
TPS-ECC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Child inhibitory control
Parent Reading Behaviors - Infancy
Socioemotional adjustment - BITSEA
+2 moreSecondary outcome measures
Harsh parenting
Parent anxiety symptoms
Parent depressive symptoms
+5 moreTPS-ECC Trial Design
4Treatment groups
Experimental Treatment
Group I: Serious ChallengesExperimental Treatment3 Interventions
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.
Group II: Moderate ChallengesExperimental Treatment2 Interventions
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.
Group III: Lower Resources/Lower ChallengesExperimental Treatment2 Interventions
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.
Group IV: Higher resources/lower challengesExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Video Interaction Project
2005
N/A
~680
Find a Location
Who is running the clinical trial?
The Shear Family FoundationUNKNOWN
The Grable FoundationUNKNOWN
1 Previous Clinical Trials
246 Total Patients Enrolled
University of PittsburghLead Sponsor
1,722 Previous Clinical Trials
16,318,946 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Moderate Challenges
- Group 2: Serious Challenges
- Group 3: Lower Resources/Lower Challenges
- Group 4: Higher resources/lower challenges
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary purpose of this medical investigation?
"This prolonged research effort, covering four years of data collection and analysis, aims to gauge the socioemotional adjustment of participants with the CBCL measure. Additionally, well-child care (which includes immunization receipt) will be tracked via medical records submitted by patients; positive parenting skills for toddlers and infants are measured with PYT and PYB respectively - these measures use a range from 1 to 7 where higher scores signify better parental behavior."
Answered by AI
Are there any available vacancies for individuals to join this experiment?
"The clinical trial is currently in the enrolment phase, with data hosted on clinicaltrials.gov indicating that it was initially posted on June 2nd 2020 and updated as recently as June 29th 2022."
Answered by AI
How many people are taking part in this research initiative?
"Affirmative. According to clinicaltrials.gov, this research is actively looking for participants - the trial was originally posted on June 2nd 2020 and updated most recently on June 29th 2022. Altogether 24000 patients are required between 5 different sites.</p>"
Answered by AI
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