Clinical trial NCT06002685: 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
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Disease
Inflammation
Insufficient Sleep
Digestive Disease
Skin Conditions
Body Mass Index
Infections
Allergies
Congestion
Antibiotic Use
Overweight and Obesity
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Harvard School of Public Health (HSPH)
First posted: 2023-08-21
Enrollment: 260
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
timeFrame: This data will be gathered at Time 1 (9 months).
measure: Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
timeFrame: This data will be gathered at Time 2 (15 months).
measure: Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
timeFrame: This data will be gathered at Time 3 (24 months).
measure: Rapid Weight Gain
timeFrame: This data will be gathered at Time 1 (9 months).
measure: Rapid Weight Gain
timeFrame: This data will be gathered at Time 2 (15 months).
measure: Rapid Weight Gain
timeFrame: This data will be gathered at Time 3 (24 months).
measure: Expressive Speech Delay
timeFrame: This data will be gathered at Time 1 (9 months).
measure: Expressive Speech Delay
timeFrame: This data will be gathered at Time 2 (15 months).
measure: Expressive Speech Delay
timeFrame: This data will be gathered at Time 3 (24 months).
measure: Other Pediatric Health Problem(s)
timeFrame: This data will be gathered at Time 1 (9 months).
measure: Other Pediatric Health Problem(s)
timeFrame: This data will be gathered at Time 2 (15 months).
measure: Other Pediatric Health Problem(s)
timeFrame: This data will be gathered at Time 3 (24 months).
measure: Low Grade Inflammation
timeFrame: This data will be gathered at Time 3 (24 months).
measure: Body Mass Index
timeFrame: This data will be gathered at Time 1 (9 months).
measure: Body Mass Index
timeFrame: This data will be gathered at Time 2 (15 months).
measure: Body Mass Index
timeFrame: This data will be gathered at Time 3 (24 months).
measure: Sleep: Age 9 months
timeFrame: Sleep data will be gathered at Time 1 (age 9 months).
measure: Sleep: At 9 months
timeFrame: Sleep data will be gathered at Time 1 (at 9 months).
measure: Sleep: Age 15 months
timeFrame: Sleep data will be gathered at Time 2 (age 15 months).
measure: Sleep: At 15 months
timeFrame: Sleep data will be gathered at Time 2 (at 15 months).
measure: Sleep: Age 24 months
timeFrame: Sleep data will be gathered at Time 3 (age 24 months).
measure: Sleep: At 24 months
timeFrame: Sleep data will be gathered at Time 3 (at 24 months).
Secondary outcomes:
Other outcomes:
measure: Maternal Sensitivity during Semi-Structured Play
timeFrame: This data will be collected at Time 1 (9 months).
measure: Maternal Sensitivity during Semi-Structured Play
timeFrame: This data will be collected at Time 2 (15 months).
measure: Maternal Sensitivity to Child Distress
timeFrame: This data will be collected at Time 1 (9 months).
measure: Maternal Sensitivity to Child Distress
timeFrame: This data will be collected at Time 2 (15 months).
measure: Maternal Sensitivity during Feeding
timeFrame: This data will be collected at Time 1 (9 months).
measure: Maternal Sensitivity during Feeding
timeFrame: This data will be collected at Time 2 (15 months).
measure: Child Stress Regulation: Age 9 months
timeFrame: This data will be collected at Time 1 (9 months).
measure: Child Stress Regulation: Age 15 months
timeFrame: This data will be collected at Time 2 (age 15 months).
measure: Child Stress Regulation: At 15 months
timeFrame: This data will be collected at Time 2 (at 15 months).
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland
name: Lisa Berlin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Natalie Slopen, PhD
role: STUDY_CHAIR
affiliation: Department of Psychology and Neuroscience at UNC Chapel Hill
name: Cathi Propper, PhD
role: STUDY_CHAIR
References:
citation: Dozier M, Bernard K. Coaching parents of vulnerable infants: The Attachment and Biobehavioral Catch-Up Approach. Guilford Press; 2019.
citation: Berlin LJ, Martoccio TL, Jones Harden B. Improving early head start's impacts on parenting through attachment-based intervention: A randomized controlled trial. Dev Psychol. 2018 Dec;54(12):2316-2327. doi: 10.1037/dev0000592. Epub 2018 Oct 18.
citation: Urquhart A, Clarke P. US racial/ethnic disparities in childhood asthma emergent health care use: National Health Interview Survey, 2013-2015. J Asthma. 2020 May;57(5):510-520. doi: 10.1080/02770903.2019.1590588. Epub 2019 Apr 8.
citation: Kaar JL, Schmiege SJ, Kalkwarf HJ, Woo JG, Daniels SR, Simon SL. Longitudinal Assessment of Sleep Trajectories during Early Childhood and Their Association with Obesity. Child Obes. 2020 Apr;16(3):211-217. doi: 10.1089/chi.2019.0126. Epub 2019 Nov 21.
citation: Berlin LJ, Martoccio TL, Bryce CI, Jones Harden B. Improving infants' stress-induced cortisol regulation through attachment-based intervention: A randomized controlled trial. Psychoneuroendocrinology. 2019 May;103:225-232. doi: 10.1016/j.psyneuen.2019.01.005. Epub 2019 Jan 4.
citation: Cespedes EM, Rifas-Shiman SL, Redline S, Gillman MW, Pena MM, Taveras EM. Longitudinal associations of sleep curtailment with metabolic risk in mid-childhood. Obesity (Silver Spring). 2014 Dec;22(12):2586-92. doi: 10.1002/oby.20894. Epub 2014 Sep 19.
citation: Dowd JB, Zajacova A, Aiello A. Early origins of health disparities: burden of infection, health, and socioeconomic status in U.S. children. Soc Sci Med. 2009 Feb;68(4):699-707. doi: 10.1016/j.socscimed.2008.12.010. Epub 2009 Jan 17.
citation: Meltzer LJ, Pugliese CE. Sleep in young children with asthma and their parents. J Child Health Care. 2017 Sep;21(3):301-311. doi: 10.1177/1367493517712064. Epub 2017 Jun 5.
citation: El-Sheikh M, Buckhalt JA, Granger DA, Erath SA, Acebo C. The association between children's sleep disruption and salivary interleukin-6. J Sleep Res. 2007 Jun;16(2):188-97. doi: 10.1111/j.1365-2869.2007.00593.x.
citation: Hepworth AD, Berlin LJ, Salas K, Pardue-Kim M, Martoccio TL, Jones Harden B. Increasing maternal sensitivity to infant distress through attachment-based intervention: a randomized controlled trial. Attach Hum Dev. 2021 Dec;23(6):953-968. doi: 10.1080/14616734.2020.1834592. Epub 2020 Oct 27.
citation: Worobey J, Lopez MI, Hoffman DJ. Maternal behavior and infant weight gain in the first year. J Nutr Educ Behav. 2009 May-Jun;41(3):169-75. doi: 10.1016/j.jneb.2008.06.005.
citation: Hodges EA, Propper CB, Estrem H, Schultz MB. Feeding During Infancy: Interpersonal Behavior, Physiology, and Obesity Risk. Child Dev Perspect. 2020 Sep;14(3):185-191. doi: 10.1111/cdep.12376. Epub 2020 Jul 14.
citation: Pachter LM, Coll CG. Racism and child health: a review of the literature and future directions. J Dev Behav Pediatr. 2009 Jun;30(3):255-63. doi: 10.1097/DBP.0b013e3181a7ed5a.
citation: Williams DR, Lawrence JA, Davis BA. Racism and Health: Evidence and Needed Research. Annu Rev Public Health. 2019 Apr 1;40:105-125. doi: 10.1146/annurev-publhealth-040218-043750. Epub 2019 Feb 2.
citation: Williams DR, Lawrence JA, Davis BA, Vu C. Understanding how discrimination can affect health. Health Serv Res. 2019 Dec;54 Suppl 2(Suppl 2):1374-1388. doi: 10.1111/1475-6773.13222. Epub 2019 Oct 29.
citation: Coll CG, Magnuson K. Cultural Differences as Sources of Developmental. Handbook of early childhood intervention. 2000;
citation: Garcia Coll C, Lamberty G, Jenkins R, McAdoo HP, Crnic K, Wasik BH, Vazquez Garcia H. An integrative model for the study of developmental competencies in minority children. Child Dev. 1996 Oct;67(5):1891-914.
citation: Coll CG, Magnuson K. The psychological experience of immigration: A developmental perspective. Immigration and the family: Research and policy on US immigrants. 1997:91-131.
citation: Hepworth AD, Berlin LJ, Martoccio TL, Jones Harden B. Maternal attachment style, sensitivity, and infant obesity risk in low-income, Latino families. Attach Hum Dev. 2021 Feb;23(1):75-89. doi: 10.1080/14616734.2020.1729214. Epub 2020 Mar 4.
citation: Simons SM, Cillessen FH, Hazelzet JA. Determinants of a successful problem list to support the implementation of the problem-oriented medical record according to recent literature. BMC Med Inform Decis Mak. 2016 Aug 2;16:102. doi: 10.1186/s12911-016-0341-0.
citation: McDade TW. Measuring immune function: markers of cell-mediated immunity and inflammation in dried blood spots. In: Ice GH, James GD, eds. Measuring Stress in Humans: A Practical Guide for the Field. Cambridge Univ Press; 2007:181-207. Cambridge Studies in Biological and Evolutionary Anthropology.
citation: McDade TW, Williams S, Snodgrass JJ. What a drop can do: dried blood spots as a minimally invasive method for integrating biomarkers into population-based research. Demography. 2007 Nov;44(4):899-925. doi: 10.1353/dem.2007.0038.
citation: Ohri-Vachaspati P, Acciai F, DeLia D, Lloyd K, Yedidia MJ. Accuracy of Parent-Measured and Parent-Estimated Heights and Weights in Determining Child Weight Status. JAMA Pediatr. 2019 Aug 1;173(8):793-795. doi: 10.1001/jamapediatrics.2019.1545.
citation: Woo JG, Daniels SR. Assessment of Body Mass Index in Infancy: It Is Time to Revise Our Guidelines. J Pediatr. 2019 Jan;204:10-11. doi: 10.1016/j.jpeds.2018.09.025. Epub 2018 Oct 5. No abstract available.
citation: Acebo C, Sadeh A, Seifer R, Tzischinsky O, Wolfson AR, Hafer A, Carskadon MA. Estimating sleep patterns with activity monitoring in children and adolescents: how many nights are necessary for reliable measures? Sleep. 1999 Feb 1;22(1):95-103. doi: 10.1093/sleep/22.1.95.
citation: Buckhalt JA, El-Sheikh M, Keller P. Children's sleep and cognitive functioning: race and socioeconomic status as moderators of effects. Child Dev. 2007 Jan-Feb;78(1):213-31. doi: 10.1111/j.1467-8624.2007.00993.x.
citation: Adams EL, Master L, Buxton OM, Savage JS. A longitudinal study of sleep-wake patterns during early infancy using proposed scoring guidelines for actigraphy. Sleep Med. 2019 Nov;63:98-105. doi: 10.1016/j.sleep.2019.05.017. Epub 2019 Jun 8.
citation: Adams EL, Savage JS, Master L, Buxton OM. Time for bed! Earlier sleep onset is associated with longer nighttime sleep duration during infancy. Sleep Med. 2020 Sep;73:238-245. doi: 10.1016/j.sleep.2020.07.003. Epub 2020 Jul 14.
citation: Meltzer LJ, Mindell JA. Impact of a child's chronic illness on maternal sleep and daytime functioning. Arch Intern Med. 2006 Sep 18;166(16):1749-55. doi: 10.1001/archinte.166.16.1749.
citation: Mindell JA, Gould RA, Tikotzky L, Leichman ES, Walters RM. Corrigendum to "Norm-referenced scoring system for the Brief Infant Sleep Questionnaire - Revised (BISQ-R)" [Sleep Med 63 (2019) 106-114]. Sleep Med. 2020 Mar;67:286. doi: 10.1016/j.sleep.2019.12.012. Epub 2020 Feb 6. No abstract available.
citation: Mills-Koonce WR, Cox M. Qualitative ratings for parent-child interaction at 3-48 months of age. (Unpublished coding scales). 2013;
citation: Ursache A, Blair C, Granger DA, Stifter C, Voegtline K; Family Life Project Investigators. Behavioral reactivity to emotion challenge is associated with cortisol reactivity and regulation at 7, 15, and 24 months of age. Dev Psychobiol. 2014 Apr;56(3):474-88. doi: 10.1002/dev.21113. Epub 2013 Aug 5.
citation: Leerkes EM, Blankson AN, O'Brien M. Differential effects of maternal sensitivity to infant distress and nondistress on social-emotional functioning. Child Dev. 2009 May-Jun;80(3):762-75. doi: 10.1111/j.1467-8624.2009.01296.x.
citation: Blair C, Ursache A, Mills-Koonce R, Stifter C, Voegtline K, Granger DA; Family Life Project Investigators. Emotional reactivity and parenting sensitivity interact to predict cortisol output in toddlers. Dev Psychol. 2015 Sep;51(9):1271-7. doi: 10.1037/dev0000031. Epub 2015 Jul 20.
citation: Owen M. The NICHD study of early child care mother-infant interaction scales. Unpublished manuscript Dallas, TX: Timberlawn Psychiatric Research Foundation. 1992;
citation: NICHD Early Child Care Research Network. Characteristics and quality of child care for toddlers and preschoolers. Applied Developmental Science. 2000;4(3):116-135.
citation: Stifter CA, Moding KJ. Understanding and measuring parent use of food to soothe infant and toddler distress: A longitudinal study from 6 to 18 months of age. Appetite. 2015 Dec;95:188-96. doi: 10.1016/j.appet.2015.07.009. Epub 2015 Jul 9.
citation: Goldsmith HH, Rothbart M. The laboratory temperament assessment battery (Locomotor Version 3.1). Madison, WI: University of Wisconsin-Madison. 1999;
citation: Carter AS, Briggs-Gowan MJ, Jones SM, Little TD. The Infant-Toddler Social and Emotional Assessment (ITSEA): factor structure, reliability, and validity. J Abnorm Child Psychol. 2003 Oct;31(5):495-514. doi: 10.1023/a:1025449031360.
citation: Carter AS, Briggs-Gowan MJ. ITSEA: Infant-toddler social and emotional assessment examiner's manual. San Antonio, TX: PsychCorp. 2006;