Recruiting

COS-P

Sponsor:

University of Maryland, College Park

Code:

NCT05834907

Conditions

Parent-Child Relations

Development, Infant

Parenting

Development, Child

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Circle of Security Parenting

Little Talks

Study Details

Brief 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

Study ID

NCT05834907

Start date

Mar 27, 2023

Status verified date

Jun, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

249 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

  • Strange Situation Procedure (SSP) #1 [ Time Frame: Baseline ]
  • Strange Situation Procedure (SSP) #2 [ Time Frame: Immediately post-intervention ]
  • Strange Situation Procedure (SSP) #3 [ Time Frame: 6-month follow up ]
  • Macarthur Preschool Strange Situation (PACS) #1 [ Time Frame: Baseline ]
  • Macarthur Preschool Strange Situation (PACS) #2 [ Time Frame: Immediately post-intervention ]
  • Macarthur Preschool Strange Situation (PACS) #3 [ Time Frame: 6-month follow up ]
  • Cortisol Stress Reactivity and Recovery #1 [ Time Frame: Baseline ]
  • Cortisol Stress Reactivity and Recovery #2 [ Time Frame: Immediately post-intervention ]
  • Cortisol Stress Reactivity and Recovery #3 [ Time Frame: 6-month follow up ]
  • Child Behavior Checklist (CBCL) #1 [ Time Frame: Baseline ]
  • Child Behavior Checklist (CBCL) #2 [ Time Frame: Immediately post-intervention ]
  • Child Behavior Checklist (CBCL) #3 [ Time Frame: 6-month follow up ]
  • Infant-Toddler Social and Emotional Assessment (ITSEA) #1 [ Time Frame: Baseline ]
  • Infant-Toddler Social and Emotional Assessment (ITSEA) #2 [ Time Frame: Immediately post-intervention ]
  • Infant-Toddler Social and Emotional Assessment (ITSEA) #3 [ Time Frame: 6-month follow up ]
  • Parental Emotional Responses to Child Distress #1 [ Time Frame: Baseline ]
  • Parental Emotional Responses to Child Distress #2 [ Time Frame: Immediately post-intervention ]
  • Parental Emotional Responses to Child Distress #3 [ Time Frame: 6-month follow up ]
  • Electrodermal Activity (EDA) arousal #1 [ Time Frame: Baseline ]
  • Electrodermal Activity (EDA) arousal #2 [ Time Frame: Immediately post-intervention ]
  • Electrodermal Activity (EDA) arousal #3 [ Time Frame: 6-month follow up ]
  • Respiratory Sinus Arrhythmia (RSA) #1 [ Time Frame: Baseline ]
  • Respiratory Sinus Arrhythmia (RSA) #2 [ Time Frame: Immediately post-intervention ]
  • Respiratory Sinus Arrhythmia (RSA) #3 [ Time Frame: 6-month follow up ]
  • Coping with Toddlers' Negative Emotions Scale (CTNES) #1 [ Time Frame: Baseline ]
  • Coping with Toddlers' Negative Emotions Scale (CTNES) #2 [ Time Frame: Immediately post-intervention ]
  • Coping with Toddlers' Negative Emotions Scale (CTNES) #3 [ Time Frame: 6 month follow up ]
  • Stranger Approach Lab-TAB Task to Assess Parental Behavioral Sensitivity #1 [ Time Frame: Baseline ]
  • Jar Lab-TAB Task to Assess Parental Behavioral Sensitivity #1 [ Time Frame: Baseline ]
  • Stranger Approach Lab-TAB Task to Assess Parental Behavioral Sensitivity #2 [ Time Frame: Immediately post-intervention ]
  • Jar Lab-TAB Task to Assess Parental Behavioral Sensitivity #2 [ Time Frame: Immediately post-intervention ]
  • Stranger Approach Lab-TAB Task to Assess Parental Behavioral Sensitivity #3 [ Time Frame: 6-month follow up ]
  • Jar Lab-TAB Task to Assess Parental Behavioral Sensitivity #3 [ Time Frame: 6-month follow up ]

Central Contacts and Locations

Central contacts

Jude Cassidy, Ph.D.

301-405-4973jcassidy@umd.edu

Susan Woodhouse, Ph.D.

610-758-3269ssw212@lehigh.edu

Locations

Lehigh University

Recruiting

Bethlehem, Pennsylvania, United States, 18015

Contacts

Susan Woodhouse, Ph.D.

610-758-3269ssw212@lehigh.edu

More Information

Sponsor

University of Maryland, College Park

Last update posted

Jul 3, 2025

Last verified

Jun, 2025

Keywords

  • Parent-Child Relations
  • Development, Infant
  • Parenting
  • Development, Child
  • Attachment
  • Home Visiting
  • Early Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Maryland, College Park on 2025-07-03.