|drug1948||MVA-MERS-S_DF1 - High Dose Wiki||1.00|
|drug1949||MVA-MERS-S_DF1 - Low Dose Wiki||1.00|
There is one clinical trial.
The primary objective is to rigorously evaluate the effectiveness of the Infant Mental Health Home Visiting (IMH-HV) model on maternal and child outcomes according to legislative standards via a randomized controlled trial. The research team will recruit caregivers and their children (0-24 months) or pregnant women (n=72) from locations across Washtenaw County to participate in the IMH-HV RCT. Half of the women will be randomly assigned to a treatment as usual (TAU) control group (with access to all available community resources), and half of the women will be randomly assigned to the treatment group (i.e., IMH-HV). Women assigned to the control group will not receive IMH-HV treatment through the study team, but will not be prohibited from seeking or accessing IMH-HV treatment or any other services through community resources. Women assigned to the treatment group will receive IMH-HV treatment for 12 months through the study team with rigorous monitoring of fidelity to the IMH-HV model. All study participants will undergo assessments across the 24-month period (12 months of which are the treatment trial) (i.e., baseline (randomization will occur after baseline), mid-points (3, 6 and 9 months) and follow-ups (12, 18 and 24 months) after randomization). Additionally, all study participants will have the opportunity to participate in assessments regarding their experience of the COVID-19 pandemic. The purpose of this study is to evaluate efficacy of the Infant Mental Health Home-Visiting (IMH-HV) model on parental and child outcomes according to legislative standards and consistent with the State of Michigan's benchmarks. If this study confirms the efficacy of the IMH-HV model, this will support the sustainability of IMH-HV in the state of Michigan as evidence from a randomized controlled trial is necessary in order to access certain state and federal dollars. Access to evidence-based and sustainable parenting support can ultimately improve outcomes for this vulnerable population. Specifically this study aims to: 1. Conduct a randomized controlled trial to evaluate the efficacy of IMH-HV treatment utilizing rigorous outcomes monitoring and evaluation methodology to establish that the families served achieve the intended positive benefit. Eligible caregivers and children or pregnant women will be assigned to the control group or the treatment group and both groups will receive research assessments at regular intervals measuring key impacts of the IMH-HV model. 2. Determine IMH-HV efficacy via analysis of treatment impact on key caregiver, child, and family indicators. The hypothesis is that there will be positive impacts of IMH-HV, with caregiver, child, and family-level improvements from baseline to post assessment on key indicators, including: 1. Improved child outcomes as reflected in strengthened child physical and behavioral health, development and school readiness, and reduced risk for child maltreatment. 2. Improved parental outcomes including improved parent mental health, decreased child abuse potential, and enhanced positive parenting. 3. Improved family environment including decrease in crime and family violence, enhance linkage to referrals and improve family economics and self-sufficiency. 3. Identify factors associated with family improvement, including dosage and fidelity of treatment. It is the hypothesis that a dose-response association between the number of home visiting sessions and treatment impact, and a positive association between fidelity of treatment delivered and positive child and family outcomes.
Description: Change in caregiver PTSD symptoms via measurement on PCL-5 with a range of 0 (no symptoms) to 80 (high level symptom endorsement).Measure: PTSD Checklist (PCL-5) Time: 1 Year
Description: Change in caregiver anxiety via measurement on GAD-7 with a range of 0 (no symptoms) to 21 (high level of anxiety symptoms endorsed).Measure: Generalized Anxiety Disorder (GAD-7) Time: 1 Year
Description: Change in caregiver self-reported depression via measurement on PHQ-9 with a range of 0 (no depression symptoms) to 27 (high level of depression symptoms endorsed).Measure: Patient Health Questionnaire (PHQ-9) Time: 2 years
Description: Change in caregiver self-reported emotional distress, rigidity, social isolation (risks associated with child maltreatment) via measurement on BCAP with a range of 0-24.Measure: Brief Child Abuse Potential Inventory (BCAP) Time: 1 Year
Description: Categorization of caregiver perception of child and relationship with child that moves from distorted or disengaged to balanced via measurement on the WMCI.Measure: Working Model of the Child Interview (WMCI) Time: 1 year
Description: Change in caregiver reported social-emotional behavior problems of child via measurement on ITSEA using t-scores derived from ITSEA-provided standard normsMeasure: Infant Toddler Social-Emotional Assessment (ITSEA) Time: 1 Year
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports