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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06002685
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
8 Months - 12 Months
Healthy Volunteers
Accepted

Interventions

  • Attachment and Biobehavioral Catch-Up — BEHAVIORAL
    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).
  • Home-Based Book-of-the-Week — OTHER
    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.

Study Details

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.

Key Dates

Start date
Oct 9, 2023
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Attachment and Biobehavioral Catch-up (ABC) program
    The ABC program consists of 10 1 -hour home-based sessions delivered by a trained parent coach. Each session includes the mother and her child together and addresses a specific topic.
  • Active Comparator: Home-Based Book-of-the-Week (HBOW) program
    The HBOW program consists of 10 English/Spanish developmentally appropriate books hand-delivered weekly to the mothers. A trained RA will utilize a standard set of questions to ask about the mother's and child's well-being.

Primary Outcome Measure

Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use) [ Time Frame: This data will be gathered at Time 1 (9 months). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MarylandBaltimoreMaryland21201
Lisa Berlin, PhD
[email protected]
410.706.6392
Roderick Rose, PhD
[email protected]
410.706.7023
Lisa Berlin, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Maryland· Baltimore, MD

Related Studies