Hands and Hearts Together

NCT05834907 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2025-07-03

No results posted yet for this study

Summary

Growing evidence demonstrates that secure attachment in childhood predicts children's healthy social, biological, and behavioral functioning, whereas insecure attachment predicts behavior problems and physiological dysregulation; thus, efforts to foster secure attachment are crucial for promoting the healthy development of children and families. This proposal describes a randomized controlled trial (RCT) of an innovative intervention program that can be widely implemented designed to foster children's secure attachment, promote healthy physiological regulation, and reduce the risk for behavior problems: The Circle of Security ® Parenting (COS-P) intervention. To this end, investigators will conduct an RCT with 249 parent-child dyads enrolled or are eligible but not yet enrolled in two diverse Early Head Start (EHS) programs.

Conditions

  • Parent-Child Relations
  • Development, Infant
  • Parenting
  • Development, Child

Interventions

BEHAVIORAL

Circle of Security Parenting

COS-P is an attachment-based, home visiting intervention intended to supporting parents in serving as "a secure base" from which their children can explore the world, and to which their children can return in times of distress (Bowlby, 1988). Such secure base parenting increases the likelihood of children's secure attachment. COS-P also targets parental responses to children's expression of their needs (e.g., crying), and is designed to help parents understand the ways in which their own (parental) dysregulated emotional, physiological, and behavioral responses to children's emotions and behaviors can limit their responsiveness to their children's attachment needs.

BEHAVIORAL

Little Talks

Little Talks is an early literacy home visiting intervention developed for low-income, racial and ethnic minority infants and toddlers, and has been tested in Early Head Start contexts (Manz et al., 2016; Manz et al. 2017). Little Talks uses book sharing to promote early literacy and has been adapted in both English and Spanish. The intervention utilizes modular treatments during home visits, teaching parents how to facilitate language interactions with their children through book sharing. Age appropriate books are given to parents to share with their children during the intervention.

Sponsors & Collaborators

  • Lehigh University

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

    collaborator NIH
  • University of Maryland, College Park

    lead OTHER

Principal Investigators

  • Jude Cassidy, Ph.D. · University of Maryland, College Park

  • Susan Woodhouse, Ph.D. · Lehigh University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-27
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05834907 on ClinicalTrials.gov