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

NCT06002685 | Recruiting DMC

• 1 other identifier: HP-00103602
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (22)

• Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)

  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.

  This data will be gathered at Time 1 (9 months).

• Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)

  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.

  This data will be gathered at Time 2 (15 months).

• Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)

  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.

  This data will be gathered at Time 3 (24 months).

• Rapid Weight Gain

  This outcome will be assessed through a review of the children's Electronic Health Record.

  This data will be gathered at Time 1 (9 months).

• Rapid Weight Gain

  This outcome will be assessed through a review of the children's Electronic Health Record.

  This data will be gathered at Time 2 (15 months).

• Rapid Weight Gain

  This outcome will be assessed through a review of the children's Electronic Health Record.

  This data will be gathered at Time 3 (24 months).

• Expressive Speech Delay

  This outcome will be assessed through a review of the children's Electronic Health Record.

  This data will be gathered at Time 1 (9 months).

• Expressive Speech Delay

  This outcome will be assessed through a review of the children's Electronic Health Record.

  This data will be gathered at Time 2 (15 months).

• Expressive Speech Delay

  This outcome will be assessed through a review of the children's Electronic Health Record.

  This data will be gathered at Time 3 (24 months).

• Other Pediatric Health Problem(s)

  This outcome will be assessed through a review of the children's Electronic Health Record.

  This data will be gathered at Time 1 (9 months).

• Other Pediatric Health Problem(s)

  This outcome will be assessed through a review of the children's Electronic Health Record.

  This data will be gathered at Time 2 (15 months).

• Other Pediatric Health Problem(s)

  This outcome will be assessed through a review of the children's Electronic Health Record.

  This data will be gathered at Time 3 (24 months).

• Low Grade Inflammation

  This outcome will be assessed via markers of C-reactive protein (CRP) and interleukin-6 (IL-6) through a collection of blood spots using a traditional finger-prick. Blood spot collection is required at the 24-month pediatric well-child visit for all Baltimore City residents.

  This data will be gathered at Time 3 (24 months).

• Body Mass Index

  This outcome will be collected by an RA by measuring the child's length and weight. Length will be measured using a measurement board. All weight measurements will be obtained in a clean diaper utilizing an infant scale (Seca 374). In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.

  This data will be gathered at Time 1 (9 months).

• Body Mass Index

  This outcome will be collected by an RA by measuring the child's length and weight. Length will be measured using a measurement board. All weight measurements will be obtained in a clean diaper utilizing an infant scale (Seca 374). In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.

  This data will be gathered at Time 2 (15 months).

• Body Mass Index

  This outcome will be collected through mothers reports about their children's current length and weight. In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.

  This data will be gathered at Time 3 (24 months).

• Sleep: Age 9 months

  This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.

  Sleep data will be gathered at Time 1 (age 9 months).

• Sleep: At 9 months

  An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.

  Sleep data will be gathered at Time 1 (at 9 months).

• Sleep: Age 15 months

  This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.

  Sleep data will be gathered at Time 2 (age 15 months).

• Sleep: At 15 months

  An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.

  Sleep data will be gathered at Time 2 (at 15 months).

• Sleep: Age 24 months

  This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.

  Sleep data will be gathered at Time 3 (age 24 months).

• Sleep: At 24 months

  An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.

  Sleep data will be gathered at Time 3 (at 24 months).

Other Outcomes (9)

• Maternal Sensitivity during Semi-Structured Play

  This data will be collected at Time 1 (9 months).

• Maternal Sensitivity during Semi-Structured Play

  This data will be collected at Time 2 (15 months).

• Maternal Sensitivity to Child Distress

  This data will be collected at Time 1 (9 months).

Study Arms (2)

Attachment and Biobehavioral Catch-up (ABC) program

EXPERIMENTAL

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.

Behavioral: Attachment and Biobehavioral Catch-Up

Home-Based Book-of-the-Week (HBOW) program

ACTIVE COMPARATOR

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.

Other: Home-Based Book-of-the-Week

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).

Also known as: ABC

Attachment and Biobehavioral Catch-up (ABC) program

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.

Also known as: HBOW

Home-Based Book-of-the-Week (HBOW) program

Eligibility Criteria

• Age: 8 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Biological mothers
• Identify as Latina
• Speak English or Spanish
• Primiparous and multiparous
• Have a 9-month-old child enrolled in Medicaid

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Johns Hopkins University: collaborator
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (40)

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MeSH Terms

Conditions

Respiration Disorders; Inflammation; Sleep Deprivation; Digestive System Diseases; Skin Diseases; Infections; Hypersensitivity; Overweight; Obesity

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Mental Disorders; Skin and Connective Tissue Diseases; Immune System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Lisa Berlin, PhD

  University of Maryland

  PRINCIPAL INVESTIGATOR

• Natalie Slopen, PhD

  Harvard School of Public Health (HSPH)

  STUDY CHAIR

• Cathi Propper, PhD

  Department of Psychology and Neuroscience at UNC Chapel Hill

  STUDY CHAIR

Central Study Contacts

Lisa Berlin, PhD

CONTACT

410.706.6392; lberlin@ssw.umaryland.edu

Roderick Rose, PhD

CONTACT

410.706.7023; rrose@ssw.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 2 tasks will be coded by research assistants masked to assigned intervention condition. Child Stress Regulation: Using video-recorded data collected at Times 1 and 2, blinded coders will rate the child's emotion regulation strategies in the context of mild stressors. Coders will use the Laboratory Temperament Assessment Battery (Lab-TAB) to rate the presence/absence of the following behaviors every 5 seconds: looks to mother, communicative gestures, looks to environment; and self-stimulation. In keeping with our own and others' previous data reduction in this domain, we will compute two proportion-score composites for mother-oriented regulation and self-soothing regulation. Coders will rate children's emotional re-activity every 5 seconds to analyze emotional reactivity as a covariate. Sensitive Parenting Behaviors: At Times 1 and 2, blinded coders will collect observational assessments of sensitive parenting behaviors in 3 contexts: (a) play, (b) child distress, and (c) feeding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A 2-group, pre-and post-test experimental design (N = 260; 130 in each group) will be employed. All eligible mother-child dyads will be randomly assigned to receive the intervention, Attachment Biobehavioral Catch- up (ABC),or the control, Home-Book-of-the- Week (HBOW). Assessments will take place in the participant's home and on the phone.

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: August 21, 2023
• Study Start: October 9, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 3-5yrs after initial study publications.
• Access Criteria: There will be only one master database in which participants' ID numbers and personal identifying information are linked. Only Dr. Berlin and the staff members who are directly involved in the data collection and processing will have access to this database. Electronic data will be stored on a secure network, with password protection such that only authorized users will have access to the file server. Any original data documents such as consent forms will be kept in locked compartments separate from identifying documentation. All electronic and paper files that contain identifying information will be destroyed at the conclusion of the research. Published data will not permit the identification of individuals

Locations

US (1)