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Recruiting NCT05834907

Hands and Hearts Together

No phase Interventional Parent-Child Relations Development, Infant Parenting Development, Child

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Circle of Security Parenting, Little Talks.
Who it may be relevant to
Registry conditions: Parent-Child Relations, Development, Infant, Parenting, Development, Child. Basic parameters: from 8 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prevention of Attachment Insecurity, Physiological Dysregulation, and Child Behavior Problems

Overview

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.

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 (parent
  • 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 a

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Financial Stress Questionnaire #1 [Time frame: Baseline]
  • Financial Stress Questionnaire #2 [Time frame: Immediately post-intervention]
  • Financial Stress Questionnaire #3 [Time frame: 6-month follow-up]
  • O'Leary-Porter Overt Hostility Scale #1 [Time frame: Baseline]
  • O'Leary-Porter Overt Hostility Scale #2 [Time frame: Immediately post-intervention]
  • O'Leary-Porter Overt Hostility Scale #3 [Time frame: 6-month follow-up]
  • Adverse Childhood Experiences Questionnaire (ACE-Q) [Time frame: Baseline]
  • Role Overload #1 [Time frame: Baseline]
  • Role Overload #2 [Time frame: Immediately post-intervention]
  • Role Overload #3 [Time frame: 6-month follow-up]
  • My Exposure to Violence [Time frame: Baseline]
  • Experiences in Close Relationships Scale (ECR) #1 [Time frame: Baseline]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 2 centers
  • University of Maryland, College Park — College Park
  • Lehigh University — Bethlehem

Publications

  • Achenbach, T. M., & Rescorla, L. A. (2000). Manual for the ASEBA Preschool Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.
  • Ainsworth, M., Blehar, M., Waters, E., & Wall, S. (1978). Patterns of attachment. Erlbaum.
  • Bayley, N. 1969. Bayley scales of infant development. New York: Psychological Corp.
  • Bernard K, Dozier M. Examining infants' cortisol responses to laboratory tasks among children varying in attachment disorganization: stress reactivity or return to baseline? Dev Psychol. 2010 Nov;46(6):1771-8. doi: 10.1037/a0020660. PMID 20873923
  • Bowlby, J. (1988). A secure base. Basic Books.
  • Brennan, K. A., Clark, C. L., & Shaver, P. R. (1998). Self-report measurement of adult attachment: An integrative overview. In J. A. Simpson, W. S. Rholes, J. A. Simpson, W. S. Rholes (Eds.), Attachment theory and close relationships (pp. 46-76). Guilford.
  • Carroll KM, Nich C, Sifry RL, Nuro KF, Frankforter TL, Ball SA, Fenton L, Rounsaville BJ. A general system for evaluating therapist adherence and competence in psychotherapy research in the addictions. Drug Alcohol Depend. 2000 Jan 1;57(3):225-38. doi: 10.1016/s0376-8716(99)00049-6. PMID 10661673
  • Carter, A. S., & Briggs-Gowan, M. J. (2000). The Infant-Toddler Social and Emotional Assessment (ITSEA). Unpublished Manual. University of Massachusetts Boston Department of Psychology, Boston, MA. Yale University, New Haven, CT. Available by request at alice.carter@umb.edu.

Identifiers

NCT: NCT05834907 · 1857396-18 · 1R01HD105676-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗