Hands and Hearts Together

University of Maryland

Status: Enrolling

Conditions: Development, Child; Parenting; Parent-Child Relations; Development, Infant

Treatments: Behavioral: Circle of Security Parenting; Behavioral: Little Talks

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05834907

1R01HD105676-01A1 (U.S. NIH Grant/Contract)

1857396-18

Details and patient eligibility

About

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.

Enrollment: 249 estimated patients

Sex: All

Ages: 8+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Parents whose children (age 8 to 36 months) are enrolled or are eligible to be enrolled in Harrisburg PA and Lehigh Valley PA Early Head Start programs

Exclusion criteria

• Parents who are not sufficiently fluent in the language in which COS-P intervention will be conducted (Spanish or English)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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249 participants in 2 patient groups

Circle of Security Parenting (COS-P)

Experimental group

Description:

These participants will receive the Circle of Security Parenting (COS-P) intervention, an attachment-based, manualized, 8-session (90 minutes/session), home visiting intervention.

Treatment:

Behavioral: Circle of Security Parenting

Little Talks

Active Comparator group

Description:

These participants will receive the Little Talks intervention, a manualized, 8-session (90 minutes/session) early literacy home visiting intervention.

Treatment:

Behavioral: Little Talks