Parenting Programs for New Families

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

368 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to understand if a parenting program that helps couples learn to parent as a team and maintain a healthy lifestyle, such as maintaining safer levels of alcohol use, promotes parent and child health and well-being. Programs will be delivered prenatally and postnatally and will include both group classes and individualized sessions. A comprehensive assessment is administered during pregnancy and then at 6 and 12 months of child age. It is hypothesized that targeting intervention during the naturally motivating transition to parenthood may not only provide opportunities for long lasting behavioral change for parents, but also initiate a cascade of protective processes that ultimately reduce risk for negative emotional and behavioral outcomes for children.

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 data supports the effectiveness of the treatment Family Foundations, Healthy Foundations for new families?

Research shows that the Family Foundations program, a transition-to-parenting intervention, has positive effects on parent and child outcomes two years after birth. Additionally, parenting programs in general have been found to improve parent-child interactions and mental health outcomes, which suggests that similar benefits may be expected from this treatment. ^{1 2 3 4 5}

Is the Parenting Programs for New Families treatment safe for participants?

The available research on programs like Family Foundations and Healthy Families America suggests they are generally safe for participants. These programs focus on improving parenting skills and child development, with no significant safety concerns reported in the studies reviewed. ^{1 6 7 8 9}

How is the Family Foundations, Healthy Foundations treatment different from other parenting programs?

Family Foundations, Healthy Foundations is unique because it focuses on supporting new families during the transition to parenthood, which is a critical period for establishing a nurturing family environment. Unlike other programs that may target specific issues like substance abuse or adolescent parenting, this treatment is designed to enhance the overall quality of the early family environment universally. ^{10 11 12 13 14}

Research Team

Rina D Eiden, PhD

Principal Investigator

Penn State

Stephanie Godleski, PhD

Principal Investigator

Rochester Institute of Technology

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

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

Family and Child Outcomes 2 Years After a Transition to Parenthood Intervention. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Fidelity Assessment Checklist Development for Community Nursing Research in Early Childhood. [2023]

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

Parents' Perceptions and Experiences of Parenting Programmes: A Systematic Review and Metasynthesis of the Qualitative Literature. [2021]

4. United States 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. [2022]

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

Psycho-education to enhance couples' transition to parenthood. [2022]

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

Healthy Families America effectiveness: a comprehensive review of outcomes. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Programs for parents of infants and toddlers: recent evidence from randomized trials. [2022]

8. England 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. [2021]

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

Examining Impacts of Healthy Families America on Infant Health Care. [2023]

10. Canada 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. [2022]

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

Parenting education as family support for low-income families of young children. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Reach and predictors of effects during nation-wide dissemination of the universal parenting program All Children in Focus. [2023]

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

Parenting services for families affected by substance abuse. [2004]

14. 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]