Inflammation Clinical Trial
Official title:
Effects of Attachment-Based Intervention on Low-Income Latino Children's Emerging Health Outcomes
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03995979 -
Inflammation and Protein Restriction
|
N/A | |
Completed |
NCT03255187 -
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT03577223 -
Egg Effects on the Immunomodulatory Properties of HDL
|
N/A | |
Completed |
NCT04383561 -
Relationship Between LRG and Periodontal Disease
|
N/A | |
Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT04856748 -
Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
|
||
Completed |
NCT05529693 -
Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population
|
N/A | |
Recruiting |
NCT05415397 -
Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
|
Phase 3 | |
Recruiting |
NCT05670301 -
Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases
|
N/A | |
Recruiting |
NCT04543877 -
WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study
|
Early Phase 1 | |
Recruiting |
NCT05775731 -
Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
|
||
Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
Completed |
NCT03429920 -
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
|
N/A | |
Completed |
NCT06065241 -
Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals.
|
N/A | |
Completed |
NCT05864352 -
The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
|
||
Completed |
NCT03318731 -
Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males
|
N/A | |
Not yet recruiting |
NCT06134076 -
Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota
|
N/A | |
Not yet recruiting |
NCT06159543 -
The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes
|
N/A |