Family Intervention Programs for Infant Development

Not currently recruiting at 1 trial location
CL
Overseen ByCheryl Lee, MA
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of Notre Dame
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how family programs can improve infants' mental health and social skills. It compares different methods of supporting families, such as enhancing parent-baby interactions and improving couple communication. The trial will determine which approach works best for various families. It is suitable for parents living together with healthy infants who have no health problems. As an unphased trial, this study provides families the opportunity to contribute to valuable research that could enhance parenting support programs.

Do I need to stop 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?

Research shows that the Sensitivity Intervention is generally easy for participants to handle and has positive effects. Studies have found that these interventions help parents better understand and respond to their child's needs, reducing disorganized attachment, where a child feels unsure about connecting with their parents.

For the Couples Intervention, research indicates that programs aimed at improving communication between partners are effective. They help parents collaborate more smoothly in raising their child and can enhance the quality of their relationship. Participants report finding this type of intervention helpful.

The combined Sensitivity and Couples Intervention addresses both areas. Research suggests that this comprehensive approach strengthens the parent-child relationship and improves child behavior. Participants usually find these interventions beneficial and easy to manage.

Overall, these interventions are considered safe and have shown positive outcomes for both parents and children. They are designed to support families in a gentle and constructive way, making them a popular choice for many.12345

Why are researchers excited about this trial?

Researchers are excited about these family intervention programs for infant development because they offer a unique approach to enhancing infant-parent relationships. Unlike traditional programs that might focus solely on parental education, these interventions emphasize improving parental sensitivity and couples' communication directly through home visits, now conducted via Zoom. This dual focus not only helps strengthen the parent-infant bond but also improves the overall family dynamic, which can be crucial for an infant's development. By delivering these interventions in a remote format, they remain accessible and adaptable, particularly in situations like the COVID-19 pandemic. This innovative approach could lead to more effective and resilient family support systems.

What evidence suggests that this trial's interventions could be effective for infant development?

This trial will compare different family intervention programs for infant development. Research has shown that early programs aimed at enhancing parental sensitivity can improve mother-child interactions and protect children from the harmful effects of difficult early experiences. In this trial, some participants will receive a Sensitivity Intervention, focusing on enhancing parental sensitivity.

For couples, research indicates that improving how parents work together can strengthen their relationship and create a better home environment for their baby. Participants in this trial may receive a Couples Intervention, which focuses on enhancing constructive communication between partners.

Additionally, the trial includes a combined Sensitivity and Couples Intervention arm. Evidence suggests that a happy parental relationship is linked to better social development in babies. These findings support the idea that focusing on both parent-child and partner relationships can lead to healthier family dynamics and child development.12367

Who Is on the Research Team?

EM

E M Cummings, Ph.D.

Principal Investigator

University of Notre Dame

JB

Julia Braungart-Rieker, Ph.D.

Principal Investigator

Colorado State University

Are You a Good Fit for This Trial?

This trial is for cohabiting parents with healthy infants who have no known health problems. Both mothers and fathers must agree to participate. It's designed to help improve child and family health by enhancing early experiences and attachment.

Inclusion Criteria

Parents cohabiting
Both my partner and I agree to participate.
My infant is healthy with no known health issues.

Exclusion Criteria

Discovery of developmental delays or health problems in infants

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I: Pre-test and Intervention

Lab and home pre-test for infants 6 months of age followed by an 8-week intervention period

8 weeks
Home visits (in-person or remote via Zoom)

Phase II: Post-test

Initial post-test conducted 12 months after the start of the study

12 months
Remote assessments via Zoom

Phase III: Follow-up Post-test

Second post-test conducted 16-18 months after the start of the study

16-18 months
Remote assessments via Zoom

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Control
  • Couples' Intervention
  • Sensitivity and Couples' Intervention
  • Sensitivity Intervention
Trial Overview The study tests the effectiveness of family programs, including a Couples' Intervention, Sensitivity Intervention, both combined, or no intervention (Control). It aims to find cost-effective ways to support infant development and parent relationships.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Sensitivity and Couples InterventionExperimental Treatment1 Intervention
Group II: Sensitivity InterventionExperimental Treatment1 Intervention
Group III: Couples InterventionExperimental Treatment1 Intervention
Group IV: ControlExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Notre Dame

Lead Sponsor

Trials
36
Recruited
60,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Citations

A Research Program Testing the Effectiveness of a ...This paper will describe a program of research testing a prevention intervention — Couple CARE for Parents (CCP), originally developed in Australia — that ...
Couple Relationship Quality and the Infant Home ...The current study aimed to examine the unique association of couple relationship quality on infants' home language environment.
A couple-focused intervention during transition to parenthoodResearch indicates that interventions emphasising enhancing co-parenting can be effective. This study is based on the hypothesis that enhancing co-parenting ...
Psycho-education to enhance couples' transition ...This paper reviews randomized controlled trials of psycho-education to assist new parent couples with parenting and their couple relationship.
Systematic Review of Interventions with Parents in the ...A total of 14 studies found positive results in this domain, and interventions spanned from one to 20 sessions, with an average of seven meetings. Most reviewed ...
Postpartum romantic attachment and constructiveness: The ...We investigated the effects of a rigorous, psycho-educational conflict communication intervention for supporting parents' relationship functioning.
Leveraging the interpersonal context of child development ...In this paper, we contend that a universal prevention approach that centers the development of psychopathology within the context of the parent-child dyad can ...
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