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

Study Overview
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Brief Summary
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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.

Detailed Description
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The proposed RCT will test the impacts of the Attachment Biobehavioral Catch-up (ABC) intervention program on child health outcomes. A total of 260 male and female infants will be enrolled in this study, with an age range of 8-12 months (infant) and 13 months- 23 months (toddler). This study will enroll primiparous and multiparous mothers who identify as Latina, speak English or Spanish, and have a 9-month-old child enrolled in Medicaid at the start of the study. Participants will be recruited in collaboration with the Children's Medical Practice (CMP) at Johns Hopkins Bayview Medical Center and matriculated on a rolling basis. Each participant will participate for approximately 15 months; the time required to complete the Time 1 assessment, either 10-week condition, and the two post-intervention assessments. The entire study is anticipated to be completed in 5 years. This RCT will test maternal sensitivity and child stress regulation as mediators of intervention effects. It will also examine the extent to which sociocultural factors moderate the effects of ABC. Behavioral methods and procedures will include surveys/questionnaires, audio/video recordings, individual or group behavioral observations, psychosocial or behavioral interventions, and other psychosocial or behavioral procedures. This RCT is powered to detect small-medium intervention effects (Cohen's d's= 0.35 - 0.50). These effect sizes align with previous studies, which have shown small to large effects on maternal sensitivity (d's = 0.23 - 0.77) and small to medium effects on main and moderated child behavioral stress regulation (d's= 0.15 - 0.48) and child physiological (cortisol) regulation, via maternal sensitivity (d=-0.36). For .80 power or higher and a two-tailed significance level of .05, power analyses performed using Optimal Design, Webpower, and Gpower software indicated a post-attrition sample size of N=221 will adequately detect main, mediated, and moderated effects of comparable size. Analyses will be conducted in SAS 9.4, SPSS 25.0, and Mplus 8 and will include regression and structural equation models. Missing data will be accommodated using multiple imputations and/or full information maximum likelihood (FIML) and estimators that are robust to non-normality when missing data are present (e.g., MLR). Data safety monitoring will be conducted by the Principal Investigators and the external Data Safety and Monitoring Board, who will review adverse events, enrollment numbers, procedure reports, raw data, outcomes, preliminary analyses, and other data which will be completed on an ongoing basis and reported to the IRB and a sponsor. Study findings stand to inform the nature and timing of preventive interventions to reduce health disparities that disproportionately impact Latino families and will advance understanding of early social influences that promote health development across the lifespan.

Official Title
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Effects of Attachment-Based Intervention on Low-Income Latino Children's Emerging Health Outcomes

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

Intervention / Treatment
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* Behavioral: Attachment and Biobehavioral Catch-Up
* Other: Home-Based Book-of-the-Week


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attachment and Biobehavioral Catch-up (ABC) program<br>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<br>* 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).<br>* Other names: ABC;|
| Active Comparator: Home-Based Book-of-the-Week (HBOW) program<br>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<br>* 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.<br>* Other names: HBOW;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |