Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention

NCT06002685 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-01-13

No results posted yet for this study

Summary

The goal of this randomized controlled trial is to evaluate the impacts of an attachment-based intervention (Attachment Biobehavioral Catch-Up (ABC) and Home Book-of-the-Week (HBOW) program on emerging health outcomes (i.e., common childhood illnesses, body mass index, and sleep) in low-income Latino children (N=260; 9 months at enrollment). It is hypothesized that children randomized to ABC will have better health outcomes in comparison to the HBOW control group.

Conditions

  • Respiratory Disease
  • Inflammation
  • Insufficient Sleep
  • Digestive Disease
  • Skin Conditions
  • Body Mass Index
  • Infections
  • Allergies
  • Congestion
  • Antibiotic Use
  • Overweight and Obesity

Interventions

BEHAVIORAL

Attachment and Biobehavioral Catch-Up

The ABC program consists of 10 one-hour home-based sessions delivered by a trained parent coach. Each session includes the mother and her child together and addresses a specific topic. Principal intervention activities include a discussion of basic attachment principles, guided practice of new parenting behaviors, and a review of video clips from previous sessions to help reinforce parenting targets. The parent coach promotes (a) nurturance, especially in response to distress; (b) following the child's lead with delight; and (c) avoiding frightening caregiving behavior. As specified by the ABC protocol, any/all other family members will be invited to observe or participate in each ABC session Each full-time ABC parent coach will serve 8 to 10 families at a time (i.e., complete 8-10 hourly ABC visits per week).

OTHER

Home-Based Book-of-the-Week

The HBOW program is an active control condition developed by PI Berlin. It consists of 10 English/Spanish developmentally appropriate books hand-delivered weekly to the mothers. During each of the 10 weeks, a trained RA will visit each HBOW mother to drop off the book and to ask briefly about the mother's and child's well-being (using a standard set of questions). Thus, this condition will parallel the intervention condition in duration (number of weeks) and structure, although it will be less intensive in terms of participant contact time per visit.

Sponsors & Collaborators

  • Johns Hopkins University

    collaborator OTHER
  • Harvard School of Public Health (HSPH)

    collaborator OTHER
  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Lisa Berlin, PhD · University of Maryland

  • Natalie Slopen, PhD · Harvard School of Public Health (HSPH)

  • Cathi Propper, PhD · Department of Psychology and Neuroscience at UNC Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06002685 on ClinicalTrials.gov