Parenting Programs for New Families

Not currently recruiting at 1 trial location

Overseen By Rina D Eiden

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Plural pregnancy, Illicit drug use

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a parenting program, such as Family Foundations or Healthy Foundations, can help new parents collaborate effectively and maintain health, particularly by reducing alcohol use. The program, offered before and after the baby's birth, includes group classes and one-on-one sessions. Researchers hope to improve the well-being of both parents and children. The trial is open to pregnant couples who live together, speak English, and have moderate to heavy alcohol use. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance family health and dynamics.

Will I have to stop taking my current medications?

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

What prior data suggests that these parenting programs are safe for families?

Research shows that both the Family Foundations and Healthy Foundations programs improve parenting skills and child development. Studies have found these programs safe, with no major safety concerns.

Family Foundations offers classes for expecting and new parents to help them work together effectively. Previous studies have not reported any negative effects from this program. Instead, it strengthens family bonds, benefiting both parents and children.

Similarly, Healthy Foundations focuses on creating healthy and safe family environments. Reviews of programs like Healthy Foundations have not identified any safety issues. The program emphasizes education and support, which participants generally appreciate.

Overall, research supports the safety of these programs, showing they are well-received and beneficial for families. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parenting Programs for New Families trial because it aims to explore innovative approaches to supporting new parents. Unlike conventional parenting classes that might follow a one-size-fits-all model, the Family Foundations program is tailored specifically for expecting first-time parents and includes personalized family check-ins. This personalized approach could lead to better outcomes by addressing the unique needs of each family. Meanwhile, Healthy Foundations offers a community-based model, encouraging participants to engage with their local support networks. By comparing these two approaches, researchers hope to discover more effective ways to foster healthy family dynamics right from the start.

What evidence suggests that this trial's parenting programs could be effective for promoting parent and child health and well-being?

Research has shown that the Family Foundations program, available to participants in this trial, helps expecting parents by enhancing cooperation, reducing stress, and lowering depression and anxiety. Studies indicate it can lead to healthier births and less family conflict. Participants in this program have experienced significant improvements in emotional well-being and parenting support.

The Healthy Foundations program, another treatment option in this trial, has proven to improve parenting attitudes and create healthier family environments. It emphasizes better prenatal health and supports parents' educational goals. Evidence suggests it effectively promotes both physical and behavioral health in families. ^{3 5 6 7 8}

Who Is on the Research Team?

Rina D Eiden, PhD

Principal Investigator

Penn State

Stephanie Godleski, PhD

Principal Investigator

Rochester Institute of Technology

Are You a Good Fit for This Trial?

This trial is for English-speaking, cohabitating couples over 18 expecting a single child and who drink moderately to heavily. It's not for those expecting multiples or using drugs beyond cannabis.

Inclusion Criteria

My parents are at least 18 years old.

Couples who are living together and expecting a baby.

English speaking

Exclusion Criteria

You are pregnant with more than one baby.

The participant's parents have used illegal drugs (excluding marijuana).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Program

Participants engage in a parenting program delivered prenatally, including group classes and individualized sessions

Duration not specified

Postnatal Program

Participants continue the parenting program postnatally, with assessments at 6 and 12 months of child age

12 months

Assessments at 6 and 12 months

Follow-up

Participants are monitored for parent and child health and well-being outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Family Foundations
• Healthy Foundations

Trial Overview

The study tests 'Family Foundations' and 'Healthy Foundations,' programs designed to improve co-parenting skills and reduce alcohol use in new parents, with classes before and after the baby arrives.

How Is the Trial Designed?

Group I: Family Foundations Experimental Treatment 1 Intervention

An adapted Family Foundations parenting program for expecting first time parents with individual family check ins will be implemented to all participants assigned to this arm.

Group II: Healthy Foundations Active Control 1 Intervention

A community-based parenting education program with individual family check ins will be implemented to all participants assigned to this arm.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Rochester Institute of Technology

Collaborator

Trials

15

Recruited

5,500+

University at Buffalo

Collaborator

Trials

139

Recruited

105,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

The Nurturing Program for Families in Substance Abuse Treatment and Recovery effectively improves parenting skills and enhances parents' satisfaction and competence, as shown by objective scales and participant reports.

The program is grounded in principles that have been proven to reduce the risks of child abuse, neglect, and substance abuse for both parents and children, indicating its potential for long-term positive outcomes in affected families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenting services for families affected by substance abuse. Moore, J., Finkelstein, N.[2004]

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]

Healthy Families America (HFA) programs have shown consistent positive impacts on parenting outcomes, such as improved parenting attitudes, based on a review of 33 evaluations, including 15 studies with control groups.

Mixed results in areas like child health and development suggest that further research is needed to understand the factors influencing outcomes, with site implementation quality and family risk levels being key considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy Families America effectiveness: a comprehensive review of outcomes. Harding, K., Galano, J., Martin, J., et al.[2019]

Parenting intervention programs have the potential to significantly improve children's health and development, but many existing programs have not met the necessary standards for effectiveness, leading to failures in large-scale initiatives.

Evidence suggests that certain programs, particularly nurse home visiting for pregnant women and young parents, can produce consistent positive outcomes for children's health and development across diverse populations and settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programs for parents of infants and toddlers: recent evidence from randomized trials. Olds, DL., Sadler, L., Kitzman, H.[2022]

In a 5-month study involving 319 parents, the text messaging program (MyTeen) successfully recruited 221 participants, surpassing the target of 214, indicating effective recruitment strategies.

Web-based recruitment methods were particularly effective, but challenges remained in engaging ethnic minority groups and fathers, highlighting the need for targeted outreach in future parenting program trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment and Retention of Parents of Adolescents in a Text Messaging Trial (MyTeen): Secondary Analysis From a Randomized Controlled Trial. Chu, JTW., Wadham, A., Jiang, Y., et al.[2022]

The Incredible Years parenting program, studied in 1,799 participants across 14 trials, effectively improves parenting practices and reduces children's conduct problems and ADHD symptoms, with no evidence of harmful effects.

While the program enhances certain family dynamics, it does not significantly improve children's emotional problems or parental mental health, indicating its benefits are somewhat limited to specific areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research Review: Harnessing the power of individual participant data in a meta-analysis of the benefits and harms of the Incredible Years parenting program. Leijten, P., Gardner, F., Landau, S., et al.[2021]

The 'Creating Opportunities for Parent Empowerment' program significantly reduced maternal stress, depression, and anxiety in parents of preterm infants, leading to improved mental health outcomes by 2 months after discharge.

Infants whose parents participated in the program had a shorter NICU stay by an average of 3.8 days and a total hospital stay that was 3.9 days shorter compared to those in the comparison group, indicating the program's efficacy in enhancing parent-infant interactions and reducing hospitalization time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing premature infants' length of stay and improving parents' mental health outcomes with the Creating Opportunities for Parent Empowerment (COPE) neonatal intensive care unit program: a randomized, controlled trial. Melnyk, BM., Feinstein, NF., Alpert-Gillis, L., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3683104/

The Effects of the Family Foundations Prevention Program on ...

These effects accounted for between 39 and 55% of the intervention's impact on child adjustment problems. Coparenting positivity did not mediate program effects ...

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cebc4cw.org

cebc4cw.org/program/family-foundations/detailed

CEBC » Family Foundations › Program › Detailed

Results indicate that FF participants displayed significant improvement on coparental support, maternal depression and anxiety, distress in the parent-child ...

3.

healthychild.ucla.edu

healthychild.ucla.edu/sites/default/files/media/documents/familyfoundationsreport.ca_.pdf

Every child deserves strong family foundations

FF was reviewed by numerous expert panels. They have resulted in high ratings for effectiveness, rigor of the research, and ease of dissemination. A ...

4.

amchp.org

amchp.org/wp-content/uploads/2021/05/Family-Foundations-Practice-Handout-Best-PRACTICE-3-17-22-002.pdf

Family Foundations - MCH Innovations Database

Results in the first trial indicated that Family Foundations families showed better co-parenting, lower parental stress, depression, anxiety; better birth ...

5.

prevention.psu.edu

prevention.psu.edu/flagship_intitiative/family-foundations/

Family Foundations

Overview · better birth outcomes · reduced postpartum depression · reduced postpartum weight retention · lower mother and father stress · reduced family violence, ...

6.

preventionservices.acf.hhs.gov

preventionservices.acf.hhs.gov/programs/807/show

Family Foundations

Family Foundations (FF) is a parenting education program designed for couples expecting their first child. FF aims to help couples develop a team approach ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3178882/

Intervention Effects on Coparenting, Parent/Infant Well-Being ...

In this article, we present the first results of a randomized trial of Family Foundations (FF), a universal prevention program that was developed to enhance ...

8.

ocd.pitt.edu

ocd.pitt.edu/sites/default/files/EHS%20Annual%20Report%202024%20Final.pdf

ANNUAL REPORT - Office of Child Development

During the 2023-2024 grant year, the program collected ASQ-3 screening data on 145 children and ... Family Foundations has not only helped her build a strong ...