Early Childhood Support Programs for Child Development

(TPS-ECC Trial)

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

24000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Family Center Warm Referral, Family Support Referral, Community-Based Referral Process, Family Check-UP, Family Check-Up, FCU, Healthy Families America Warm Referral, Healthy Families America Warm Referral, Nurture Program Warm Referral, Smart Beginnings, SMART Beginnings, PlayReadVIP, Family Check-up (FCU), Text4Baby or Bright by Text Referral, Text4Baby, Bright by Text, Video Interaction Project, VIP, Video Interaction Project?

The Family Integrated Care (FICare) model, which shares principles with some of these treatments, has shown positive outcomes such as improved parent-infant relationships and infant developmental outcomes. Additionally, programs like 'First Five' have increased adherence to well-child care, which is crucial for child development. ^{1 2 3 4 5}

Is the Early Childhood Support Program safe for children?

The research articles provided do not contain specific safety data for the Early Childhood Support Programs or their various names. However, these programs generally focus on preventive care, developmental screening, and family support, which are typically considered safe for children. ^{6 7 8 9 10}

How does the Early Childhood Support Programs treatment differ from other treatments for child development?

The Early Childhood Support Programs treatment is unique because it uses a structured educational program called 'health coaching' to empower families of children with developmental delays. This approach provides information and social support, aiming to reduce the burden on traditional health services, which often have long wait times and service gaps. ^{11 12 13 14 15}

Research Team

Elizabeth Miller, MD, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A program evaluation of postpartum/newborn home visitation services in aiken county, South Carolina. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

"First Five" Quality Improvement Program Increases Adherence and Continuity with Well-child Care. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Family Integrated Care for Preterm Infants. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Mobile-Enhanced Family-Integrated Care for Preterm Infants: Nurse and Physician Views About Implementation. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Patient- and Family-centered Rounding: A Single-site Look into the Room. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

The Healthy Kids Check - is it evidence-based? [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Virtual Visits for Developmental Screening in High-Risk Infants. [2023]

8. England pubmed.ncbi.nlm.nih.gov

What would help low-income families? Results from a North American survey of 2-1-1 helpline professionals. [2020]

9. United States 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. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Well-child care: effectiveness of current recommendations. [2017]

11. Switzerland 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. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Implementation of Reach Up early childhood parenting program: acceptability, appropriateness, and feasibility in Brazil and Zimbabwe. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

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

14. England pubmed.ncbi.nlm.nih.gov

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

15. England pubmed.ncbi.nlm.nih.gov

The Family Startup Program: study protocol for a randomized controlled trial of a universal group-based parenting support program. [2018]