Early Childhood Support Programs for Child Development

(TPS-ECC Trial)

Not currently recruiting at 4 trial locations

Overseen By Daniel S Shaw, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Non-English speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help families with young children by testing various support programs designed to improve child development. The researchers seek to understand which programs best assist families facing challenges like low income, mental health issues, or parenting difficulties. Participants can select from options such as the Nurture Program, Smart Beginnings, or Text4Baby, based on their specific needs. Families residing in Allegheny County who are legal custodians of a child and face these challenges may find this trial suitable. As an unphased trial, it offers families the chance to explore innovative support programs tailored to their unique needs.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study demonstrated that the Nurture Program positively affects child development and parenting skills. This program aims to assist parents and enhance child safety and well-being. Similarly, the Video Interaction Project has received positive feedback, with studies highlighting its benefits in enhancing parenting and supporting child development through regular feedback.

The Smart Beginnings program boosts early learning in young children. Research shows it helps parents effectively support their child's development. Family Check-Up has a track record of improving parenting practices, which can prevent future behavioral issues in children.

Healthy Families America is a well-known program, with evidence from over 40 peer-reviewed articles demonstrating its effectiveness in supporting family health. Text4Baby and Bright by Text are text messaging services that provide valuable health information to new parents. Studies have shown these services to be safe and helpful in promoting maternal and child health.

Lastly, Family Center Warm Referral programs are community-based and focus on providing various support services to families. While specific safety data might not be detailed, these programs are part of well-established efforts to support families in need.

Overall, these interventions are generally well-tolerated and have a history of positive outcomes, making them a safe choice for families considering participation in such trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these early childhood support programs because they offer personalized interventions tailored to varying levels of family challenges and resources, which is not common in standard care. Unlike traditional programs that might use a one-size-fits-all approach, these interventions adapt to specific needs, such as providing the Smart Beginnings program for families facing serious challenges like opioid use or homelessness. Additionally, the use of innovative tools like Text4Baby or Bright by Text introduces a modern delivery method leveraging mobile technology to support families, making it more accessible and engaging for tech-savvy parents. This trial aims to find out how these targeted, flexible interventions can better support child development compared to existing options.

What evidence suggests that this trial's treatments could be effective for child development?

Research shows that the Nurture Program, an option in this trial, enhances child safety and development by improving parenting skills. Participants in the "Moderate Challenges" and "Lower Resources/Lower Challenges" arms may select this program. Studies have found that the Video Interaction Project, also available in these arms, aids child growth and reduces parental stress through video-feedback sessions.

Participants in the "Serious Challenges" arm may choose Smart Beginnings, which has successfully prepared children for school and supported early learning in low-income families. The Family Check-Up program, another option in this arm, has improved parenting skills and children's behavior. Healthy Families America, available for children less than two weeks old in the "Serious Challenges" arm, has strong evidence of promoting healthy child growth and strengthening parent-child relationships.

In the "Higher Resources/Lower Challenges" arm, participants may choose Text4Baby or Bright by Text, which have supported positive interactions between caregivers and children and provided useful information to new parents. These programs have a strong history of improving outcomes for children and families. ^{6 7 8 9 10}

Who Is on the Research Team?

Elizabeth Miller, MD, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Allegheny County Residency, legal custodian of child

Exclusion Criteria

Non-English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Families' resources and challenges are assessed to tailor intervention options

4 weeks

1 visit (in-person)

Intervention

Participants receive tailored preventive interventions based on their assessed needs

4 years

Multiple visits (in-person and virtual) at various community locations

Follow-up

Participants are monitored for changes in socioemotional adjustment and parenting skills

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Family Center Warm Referral
• Family Check-UP
• Healthy Families America Warm Referral
• Nurture Program Warm Referral
• Smart Beginnings
• Text4Baby or Bright by Text Referral
• Video Interaction Project

Trial Overview

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.

How Is the Trial Designed?

Group I: Serious Challenges Experimental Treatment 3 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 Challenges Experimental Treatment 2 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 Challenges Experimental Treatment 2 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 challenges Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

The Shear Family Foundation

Collaborator

Trials

1

Recruited

24,000+

The Grable Foundation

Collaborator

Trials

2

Recruited

24,200+

Heinz Endowments

Collaborator

Trials

4

Recruited

24,900+

Published Research Related to This Trial

Family Integrated Care (FICare) significantly enhances parental empowerment and self-efficacy for parents of hospitalized preterm infants, leading to better parent-infant relationships and improved developmental outcomes for infants.

The FICare model promotes a strengths-based, family-centered approach that addresses the stress of parent-infant separation, although there are challenges in implementing and maintaining its quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Integrated Care for Preterm Infants. Franck, LS., Waddington, C., O'Brien, K.[2021]

In a study of 176 infants born in 2004, those who received a postpartum home visit were four times more likely to enroll early in the WIC program, highlighting the potential effectiveness of home visiting programs in promoting early health interventions.

Only 17% of the home visits occurred within the recommended time frame, indicating a need for improvements in the timeliness of these visits to enhance program effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A program evaluation of postpartum/newborn home visitation services in aiken county, South Carolina. Ogbuanu, CA., Jones, CA., McTigue, JF., et al.[2019]

The Baby Steps Program successfully conducted developmental screenings for 3,343 children over 43 months, effectively identifying those eligible for early intervention services.

The program improved healthcare providers' ability to screen for and address developmental delays, facilitating referrals to community resources for better support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developmental screening in community health care centers and pediatric practices: an evaluation of the Baby Steps Program. Shannon, P., Anderson, PR.[2019]

The Family Check-Up (FCU) intervention model has been shown to effectively enhance family management skills and reduce risk behaviors in at-risk children and families over 20 years of research.

Implementing the FCU in schools has been linked to a significant reduction in the long-term risk of substance use during adolescence, highlighting its potential as a valuable public health strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based, family-centered intervention to prevent substance use: the family check-up. Stormshak, EA., Dishion, TJ.[2021]

In a study observing 200 rounding encounters at a tertiary medical center, it was found that families were invited to participate in only 60% of the rounds, indicating a gap in family-centered communication despite recommendations for Patient- and Family-centered Rounds (PFCRs).

The use of lay language was limited, with only 62% of encounters utilizing it, while 99.5% of the time medical terminology was used, suggesting that medical teams may not be effectively communicating with families, which could hinder understanding and participation in decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient- and Family-centered Rounding: A Single-site Look into the Room. Rubin, A., Osborn, RR., Nowicki, MJ., et al.[2022]

The Reach Up parenting training program was well accepted in Brazil and Zimbabwe, showing that it effectively equips caregivers with skills to enhance nurturing interactions with their children.

Despite some challenges like staff turnover and competing work commitments, the program was deemed feasible to implement and demonstrated high quality in visit interactions, indicating its potential to improve parenting support in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Reach Up early childhood parenting program: acceptability, appropriateness, and feasibility in Brazil and Zimbabwe. Smith, JA., Baker-Henningham, H., Brentani, A., et al.[2019]

A quality improvement project successfully increased adherence to recommended well-child visits from 25% to 78% among children by implementing targeted interventions over a five-year period.

Continuity of care with providers also improved significantly, rising from less than 10% to 74%, highlighting the effectiveness of a multifaceted approach in enhancing both care adherence and provider relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"First Five" Quality Improvement Program Increases Adherence and Continuity with Well-child Care. Bunik, M., Galloway, K., Maughlin, M., et al.[2022]

Most components of the Healthy Kids Check (HKC) for preschool screening, such as screening for chronic otitis media and toilet habits, lack support from evidence-based guidelines, indicating a need for refinement.

The review of 34 guidelines and systematic reviews revealed inconsistencies in recommendations, highlighting a significant gap in evidence for child health surveillance in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Healthy Kids Check - is it evidence-based? Alexander, KE., Mazza, D.[2022]

The study found no significant differences in enrollment or referral rates to therapies between infants assessed via virtual visits and those assessed in person, indicating that virtual assessments can be as effective as in-person ones.

Infants who had their first developmental assessment virtually were just as likely to complete all follow-up assessments, suggesting that virtual visits do not compromise follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Visits for Developmental Screening in High-Risk Infants. Jayaraman, M., Gupta, M., Varghese, N., et al.[2023]

A survey of 471 2-1-1 referral helpline staff revealed that addressing childcare (32%), parenting (29%), and child health/health care (23%) needs could significantly improve the lives of children in low-income families.

Over half of the respondents indicated that community resources for childcare were inadequate, highlighting a critical area for improvement to support these families effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What would help low-income families? Results from a North American survey of 2-1-1 helpline professionals. Thompson, T., Roux, AM., Kohl, PL., et al.[2020]

The Family Connects (FC) program, a nurse home visiting initiative for newborns, significantly reduced child maltreatment investigations by 39% and emergency medical care use by 33% through age 5, based on a study of 549 families in Durham County, North Carolina.

These positive outcomes were consistent across various demographic groups, indicating that the FC program can effectively support families and improve child well-being when implemented broadly and with high quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Universal Postpartum Nurse Home Visiting Program on Child Maltreatment and Emergency Medical Care at 5 Years of Age: A Randomized Clinical Trial. Goodman, WB., Dodge, KA., Bai, Y., et al.[2022]

Well-child care is crucial for preventive health in children, focusing on biomedical health, development, behavior, and family functioning through regular health supervision visits.

The article reviews the effectiveness of current well-child care recommendations, including the frequency of visits and the importance of anticipatory guidance for parents, while also highlighting recent advances and future research needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Well-child care: effectiveness of current recommendations. Dinkevich, E., Ozuah, PO.[2017]

A multi-centered randomized controlled trial will evaluate the effectiveness of the BRIGHT Coaching intervention for families of preschool-aged children with developmental delays, involving 392 families across four Canadian provinces.

The intervention aims to empower families by providing structured educational resources and support over 14 sessions, with outcomes measured for family empowerment and caregiver competency at baseline, 8 months, and 12 months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BRIGHT Coaching: A Randomized Controlled Trial on the Effectiveness of a Developmental Coach System to Empower Families of Children With Emerging Developmental Delay. Majnemer, A., O'Donnell, M., Ogourtsova, T., et al.[2020]

The Family Startup Program (FSP) is a large-scale parenting support initiative in Denmark aimed at enhancing the quality of the early family environment, involving approximately 2500 first-time parents over 12 group sessions from pregnancy until the child is 15 months old.

The study will evaluate the effectiveness of FSP compared to standard prenatal care by measuring various outcomes, including parental competence, relationship quality, and child development, at multiple time points up to seven years, making it a significant contribution to understanding universal parenting support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Family Startup Program: study protocol for a randomized controlled trial of a universal group-based parenting support program. Trillingsgaard, T., Maimburg, RD., Simonsen, M.[2018]

The mobile-enhanced family-integrated care (mFICare) model was positively received by 182 NICU nurses and physicians, particularly appreciating aspects like parent-led rounds and parent classes, which enhanced parent empowerment and nurse-family relationships.

Challenges were noted, especially among physicians regarding parent participation in rounds, indicating that while mFICare is generally acceptable, further refinements are needed for optimal implementation in NICUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile-Enhanced Family-Integrated Care for Preterm Infants: Nurse and Physician Views About Implementation. Franck, LS., Hodgson, C., Gay, CL., et al.[2023]

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