Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06002685

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age8 Months to 12 Months

SexAll

Healthy volunteersAccepted

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

Full registry criteria

Inclusion Criteria: * Biological mothers * Identify as Latina * Speak English or Spanish * Primiparous and multiparous * Have a 9-month-old child enrolled in Medicaid Exclusion Criteria: * Children born prematurely (gestational age \< 37 weeks) * Children who have major complex medical conditions (e.g., heart or autoimmune conditions) that could interfere with participation in intervention sessions and/or research assessments.

Treatments and study arms

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.

Primary outcomes

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

This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.

Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)This data will be gathered at Time 2 (15 months).

Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)This data will be gathered at Time 3 (24 months).

Rapid Weight GainThis data will be gathered at Time 1 (9 months).