Actively Recruiting

Phase Not Applicable
Age: 8Months +
All Genders
Healthy Volunteers
ID05834907

Prevention of Attachment Insecurity, Physiological Dysregulation, and Child Behavior Problems in Early Head Start Families

Led by University of Maryland, College Park · Updated on 2025-07-03

249

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Maryland, College Park

Lead Sponsor

L

Lehigh University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating an intervention called the Circle of Security Parenting (COS-P) program to support secure attachment, healthy physiological regulation, and reduce behavior problems in young children. This randomized controlled trial involves 249 parent-child pairs from Early Head Start programs, focusing on early childhood development and parent-child relationships. The study compares COS-P to a literacy-focused home visiting program called Little Talks. Participants are randomly assigned to one of two groups: one receiving the COS-P intervention, which consists of eight 90-minute home sessions focused on attachment-based parenting strategies, and the other receiving the Little Talks intervention, an eight-session home visiting program promoting early literacy through book sharing. Both programs aim to be practical and suitable for diverse families. Throughout the study, children and parents are assessed at baseline, immediately after the intervention, and six months later. These assessments include observing child attachment behaviors, stress hormone levels, child behavior checklists, parental responses, physiological measures, and various questionnaires about family stress and child temperament. The study also monitors parental emotional responses and child social-emotional development to understand intervention impacts over time.

CONDITIONS

Brief Title

Hands and Hearts Together

Who Can Participate

Age: 8Months +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Parents whose children are between 8 and 36 months old
  • Children are enrolled or eligible for enrollment in Early Head Start programs in Harrisburg or Lehigh Valley, Pennsylvania
Not Eligible

You will not qualify if you...

  • Parents not sufficiently fluent in English or Spanish for the intervention language

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

Duration - 8 weeks

Participants receive one of two home visiting behavioral interventions consisting of 8 sessions, each lasting 90 minutes, conducted in the participant's home to support parenting and child development.

8 home visits (in-person)

Follow-up

Duration - 6 months

Participants are observed and assessed to evaluate the lasting effects of the intervention on child attachment, behavior, and parental responses.

Assessments at immediate post-intervention and 6-month follow-up visits

Trial Site Locations

Total: 2 locations

1

University of Maryland, College Park

College Park, Maryland, United States, 20742

Active, Not Recruiting

2

Lehigh University

Bethlehem, Pennsylvania, United States, 18015

Actively Recruiting

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Research Team

J

Jude Cassidy, Ph.D.

S

Susan Woodhouse, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Examining infants' cortisol responses to laboratory tasks among children varying in attachment disorganization: stress reactivity or return to baseline?

Kristin Bernard, Mary Dozier

https://pubmed.ncbi.nlm.nih.gov/20873923

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Alice S Carter, Margaret J Briggs-Gowan, Stephanie M Jones...

https://pubmed.ncbi.nlm.nih.gov/14561058

Experiences of discrimination: validity and reliability of a self-report measure for population health research on racism and health.

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