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

Primary Purpose

Respiratory Disease, Inflammation, Insufficient Sleep

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attachment and Biobehavioral Catch-Up
Home-Based Book-of-the-Week
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Disease

Eligibility Criteria

8 Months - 12 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Maryland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Attachment and Biobehavioral Catch-up (ABC) program

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Rapid Weight Gain
This outcome will be assessed through a review of the children's Electronic Health Record.
Rapid Weight Gain
This outcome will be assessed through a review of the children's Electronic Health Record.
Rapid Weight Gain
This outcome will be assessed through a review of the children's Electronic Health Record.
Expressive Speech Delay
This outcome will be assessed through a review of the children's Electronic Health Record.
Expressive Speech Delay
This outcome will be assessed through a review of the children's Electronic Health Record.
Expressive Speech Delay
This outcome will be assessed through a review of the children's Electronic Health Record.
Other Pediatric Health Problem(s)
This outcome will be assessed through a review of the children's Electronic Health Record.
Other Pediatric Health Problem(s)
This outcome will be assessed through a review of the children's Electronic Health Record.
Other Pediatric Health Problem(s)
This outcome will be assessed through a review of the children's Electronic Health Record.
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.
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.
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.
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.
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: 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: 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: 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: 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: 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.

Secondary Outcome Measures

Full Information

First Posted
June 6, 2023
Last Updated
September 11, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
Harvard School of Public Health (HSPH), Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT06002685
Brief Title
Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention
Official Title
Effects of Attachment-Based Intervention on Low-Income Latino Children's Emerging Health Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Harvard School of Public Health (HSPH), Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease, Inflammation, Insufficient Sleep, Digestive Disease, Skin Conditions, Body Mass Index, Infections, Allergies, Congestion, Antibiotic Use, Overweight and Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Attachment and Biobehavioral Catch-up (ABC) program
Arm Type
Experimental
Arm Description
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.
Arm Title
Home-Based Book-of-the-Week (HBOW) program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attachment and Biobehavioral Catch-Up
Other Intervention Name(s)
ABC
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Home-Based Book-of-the-Week
Other Intervention Name(s)
HBOW
Intervention Description
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 Outcome Measure Information:
Title
Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
Description
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.
Time Frame
This data will be gathered at Time 1 (9 months).
Title
Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
Description
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.
Time Frame
This data will be gathered at Time 2 (15 months).
Title
Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
Description
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.
Time Frame
This data will be gathered at Time 3 (24 months).
Title
Rapid Weight Gain
Description
This outcome will be assessed through a review of the children's Electronic Health Record.
Time Frame
This data will be gathered at Time 1 (9 months).
Title
Rapid Weight Gain
Description
This outcome will be assessed through a review of the children's Electronic Health Record.
Time Frame
This data will be gathered at Time 2 (15 months).
Title
Rapid Weight Gain
Description
This outcome will be assessed through a review of the children's Electronic Health Record.
Time Frame
This data will be gathered at Time 3 (24 months).
Title
Expressive Speech Delay
Description
This outcome will be assessed through a review of the children's Electronic Health Record.
Time Frame
This data will be gathered at Time 1 (9 months).
Title
Expressive Speech Delay
Description
This outcome will be assessed through a review of the children's Electronic Health Record.
Time Frame
This data will be gathered at Time 2 (15 months).
Title
Expressive Speech Delay
Description
This outcome will be assessed through a review of the children's Electronic Health Record.
Time Frame
This data will be gathered at Time 3 (24 months).
Title
Other Pediatric Health Problem(s)
Description
This outcome will be assessed through a review of the children's Electronic Health Record.
Time Frame
This data will be gathered at Time 1 (9 months).
Title
Other Pediatric Health Problem(s)
Description
This outcome will be assessed through a review of the children's Electronic Health Record.
Time Frame
This data will be gathered at Time 2 (15 months).
Title
Other Pediatric Health Problem(s)
Description
This outcome will be assessed through a review of the children's Electronic Health Record.
Time Frame
This data will be gathered at Time 3 (24 months).
Title
Low Grade Inflammation
Description
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.
Time Frame
This data will be gathered at Time 3 (24 months).
Title
Body Mass Index
Description
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.
Time Frame
This data will be gathered at Time 1 (9 months).
Title
Body Mass Index
Description
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.
Time Frame
This data will be gathered at Time 2 (15 months).
Title
Body Mass Index
Description
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.
Time Frame
This data will be gathered at Time 3 (24 months).
Title
Sleep: Age 9 months
Description
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.
Time Frame
Sleep data will be gathered at Time 1 (age 9 months).
Title
Sleep: At 9 months
Description
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.
Time Frame
Sleep data will be gathered at Time 1 (at 9 months).
Title
Sleep: Age 15 months
Description
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.
Time Frame
Sleep data will be gathered at Time 2 (age 15 months).
Title
Sleep: At 15 months
Description
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.
Time Frame
Sleep data will be gathered at Time 2 (at 15 months).
Title
Sleep: Age 24 months
Description
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.
Time Frame
Sleep data will be gathered at Time 3 (age 24 months).
Title
Sleep: At 24 months
Description
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.
Time Frame
Sleep data will be gathered at Time 3 (at 24 months).
Other Pre-specified Outcome Measures:
Title
Maternal Sensitivity during Semi-Structured Play
Description
This outcome will be assessed with a 15-minute "Three Bag" interaction. The mother will be given vague instructions involving 3 numbered cloth bags, each containing one or more standard, age-graded toys or books, asking that the child spend some time with each. The mother will be informed that she can play or help however she wants. Coders will use the well-established Parent-Child Interaction Rating Scales to assign a global 5-point score for the mother's sensitivity/responsiveness, intrusiveness, and positive regard. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
Time Frame
This data will be collected at Time 1 (9 months).
Title
Maternal Sensitivity during Semi-Structured Play
Description
This outcome will be assessed with a 15-minute "Three Bag" interaction. The mother will be given vague instructions involving 3 numbered cloth bags, each containing one or more standard, age-graded toys or books, asking that the child spend some time with each. The mother will be informed that she can play or help however she wants. Coders will use the well-established Parent-Child Interaction Rating Scales to assign a global 5-point score for the mother's sensitivity/responsiveness, intrusiveness, and positive regard. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
Time Frame
This data will be collected at Time 2 (15 months).
Title
Maternal Sensitivity to Child Distress
Description
This will be assessed in the context of age-graded mild stressors designed to elicit child fear or frustration, all of which have been well-validated. Before each stressor, there will be a 3-minute "baseline" period during which the child will view a neutral video. At Time 1, the stressors will consist of a 4-minute novel toy approach and 3-minute barrier task. At Time 2, the stressors will consist of a 2-minute mask task and a 3-minute barrier task. Following each stressor, there will be a 2-minute child-mother "reunion" when the mother is free to interact with her child however she wants. Mothers will be asked ahead of time not to provide a pacifier or breastfeed during these 2 minutes; after two minutes mothers can interact freely, which will allow researchers to capture mothers' "food to soothe" behaviors. Coders will rate sensitivity to child distress using a 5-point scale. If the child does not display distress, coders will rate the mother's responses to her child's other cues.
Time Frame
This data will be collected at Time 1 (9 months).
Title
Maternal Sensitivity to Child Distress
Description
This will be assessed in the context of age-graded mild stressors designed to elicit child fear or frustration, all of which have been well-validated. Before each stressor, there will be a 3-minute "baseline" period during which the child will view a neutral video. At Time 1, the stressors will consist of a 4-minute novel toy approach and 3-minute barrier task. At Time 2, the stressors will consist of a 2-minute mask task and a 3-minute barrier task. Following each stressor, there will be a 2-minute child-mother "reunion" when the mother is free to interact with her child however she wants. Mothers will be asked ahead of time not to provide a pacifier or breastfeed during these 2 minutes; after two minutes mothers can interact freely, which will allow researchers to capture mothers' "food to soothe" behaviors. Coders will rate sensitivity to child distress using a 5-point scale. If the child does not display distress, coders will rate the mother's responses to her child's other cues.
Time Frame
This data will be collected at Time 2 (15 months).
Title
Maternal Sensitivity during Feeding
Description
This outcome will be assessed in terms of maternal responsiveness to child feeding cues and the use of food to soothe child distress, both of which will be observed throughout the home-based assessments. Each home-based assessment will be schedule to include at least one opportunity to observe child feeding./ A set of developmentally and culturally appropriate snack foods will be provided to facilitated standardized observations of mothers' use of food to soothe child distress. Two validated and complementary behavioral coding schemes, the Responsiveness to Child Feeding Cues Scale and the Food to Soothe scheme will be used. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
Time Frame
This data will be collected at Time 1 (9 months).
Title
Maternal Sensitivity during Feeding
Description
This outcome will be assessed in terms of maternal responsiveness to child feeding cues and the use of food to soothe child distress, both of which will be observed throughout the home-based assessments. Each home-based assessment will be schedule to include at least one opportunity to observe child feeding./ A set of developmentally and culturally appropriate snack foods will be provided to facilitated standardized observations of mothers' use of food to soothe child distress. Two validated and complementary behavioral coding schemes, the Responsiveness to Child Feeding Cues Scale and the Food to Soothe scheme will be used. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
Time Frame
This data will be collected at Time 2 (15 months).
Title
Child Stress Regulation: Age 9 months
Description
Video recorded data collected will rate infants' emotion regulation strategies in the context of mild stressors during the above-mentioned three contexts of parenting behaviors. The Laboratory Temperament Assessment Battery will be used to rate the presence/absence of the following 5 behaviors: looks to mother, communicative gestures, looks to the environment, and self-stimulation. A two-proportion score composite will be computed for mother-oriented regulation and self-soothing regulation. Coders will also rate children's emotional reactivity every 5 seconds to analyze emotional reactivity as a covariate. This outcome will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
Time Frame
This data will be collected at Time 1 (9 months).
Title
Child Stress Regulation: Age 15 months
Description
Video recorded data collected will rate infants' emotion regulation strategies in the context of mild stressors during the above-mentioned three contexts of parenting behaviors. The Laboratory Temperament Assessment Battery will be used to rate the presence/absence of the following 5 behaviors: looks to mother, communicative gestures, looks to the environment, and self-stimulation. A two-proportion score composite will be computed for mother-oriented regulation and self-soothing regulation. Coders will also rate children's emotional reactivity every 5 seconds to analyze emotional reactivity as a covariate.
Time Frame
This data will be collected at Time 2 (age 15 months).
Title
Child Stress Regulation: At 15 months
Description
The child's emotional dysregulation will be assessed by administrating mothers the Infant-Toddler Social and Emotional Assessment (ITSEA). The following three ITSEA subscales will be examined: internalizing, externalizing, and dysregulation. This outcome will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
Time Frame
This data will be collected at Time 2 (at 15 months).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Berlin, PhD
Phone
410.706.6392
Email
lberlin@ssw.umaryland.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Roderick Rose, PhD
Phone
410.706.7023
Email
rrose@ssw.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Berlin, PhD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Natalie Slopen, PhD
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cathi Propper, PhD
Organizational Affiliation
Department of Psychology and Neuroscience at UNC Chapel Hill
Official's Role
Study Chair
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Berlin, PhD
Phone
410-706-6392
Email
LBerlin@ssw.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Roderick Rose, PhD
Phone
410.706.7023
Email
rrose@ssw.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Lisa Berlin, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD.
IPD Sharing Time Frame
3-5yrs after initial study publications.
IPD Sharing 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
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Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention

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