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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06002685
• Other study ID #: HP-00103602
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: January 2028

Study information

• Verified date: November 2023
• Source: University of Maryland, Baltimore
• Contact: Lisa Berlin, PhD
• Phone: 410.706.6392
• Email: lberlin[@]ssw.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Months to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Allergies
• Antibiotic Use
• Body Mass Index
• Congestion
• Digestive Disease
• Digestive System Diseases
• Gastrointestinal Diseases
• Infections
• Inflammation
• Overweight
• Overweight and Obesity
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Skin Conditions
• Skin Diseases
• Sleep Deprivation

Intervention

Behavioral:
• Attachment and Biobehavioral Catch-Up
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).

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

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Harvard School of Public Health (HSPH), Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal Sensitivity during Semi-Structured Play	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.	This data will be collected at Time 1 (9 months).
Other	Maternal Sensitivity during Semi-Structured Play	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.	This data will be collected at Time 2 (15 months).
Other	Maternal Sensitivity to Child Distress	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.	This data will be collected at Time 1 (9 months).
Other	Maternal Sensitivity to Child Distress	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.	This data will be collected at Time 2 (15 months).
Other	Maternal Sensitivity during Feeding	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.	This data will be collected at Time 1 (9 months).
Other	Maternal Sensitivity during Feeding	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.	This data will be collected at Time 2 (15 months).
Other	Child Stress Regulation: Age 9 months	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.	This data will be collected at Time 1 (9 months).
Other	Child Stress Regulation: Age 15 months	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 data will be collected at Time 2 (age 15 months).
Other	Child Stress Regulation: At 15 months	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.	This data will be collected at Time 2 (at 15 months).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).