Hands and Hearts Together

Part of paid clinical trials in College Park, Maryland.

Sponsor
University of Maryland, College Park
Study ID
NCT05834907
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
8 Months - N/A
Healthy Volunteers
Accepted

Interventions

  • Circle of Security Parenting — BEHAVIORAL
    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.
  • Little Talks — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Mar 27, 2023
Status verified
Jun 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
249 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Circle of Security Parenting (COS-P)
    These participants will receive the Circle of Security Parenting (COS-P) intervention, an attachment-based, manualized, 8-session (90 minutes/session), home visiting intervention.
  • Active Comparator: Little Talks
    These participants will receive the Little Talks intervention, a manualized, 8-session (90 minutes/session) early literacy home visiting intervention.

Primary Outcome Measure

Strange Situation Procedure (SSP) #1 [ Time Frame: Baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Maryland, College ParkCollege ParkMaryland20742-
Lehigh UniversityBethlehemPennsylvania18015
Susan Woodhouse, Ph.D.
[email protected]
610-758-3269

Find similar trials in College Park, MD

By research site
University of Maryland, College Park· College Park, MDLehigh University· Bethlehem, PA

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