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Abstract
Grant Number: 5R01MH058566-03 Project Title: INFORMED CONSENT IN AIDS AND MENTAL HEALTH RESEARCH
PI Information: Name Title MCKAY, MARY M. mary.mckay@mssm.edu PROFESSOR Abstract: DESCRIPTION (Adapted from the Investigator's Abstract): The primary aim of the proposed project is to increase the involvement of vulnerable populations in research by identifying factors that influence informed consent, initial involvement, and ongoing involvement in both intervention and applied developmental research with low income, minority children and their adult caregivers. Informed consent refers to the extent to which children and their adult caregivers are knowledgeable about the purpose of the study: clear about the expectations associated with participation and accurate about the risks and benefits associated with the proposed study prior to deciding to involve themselves. Initial involvement refers to actually signing a consent form in the case of adults or an assent form for children. Lastly, ongoing involvement refers to continued participation in a longitudinal study. These are proposed to be related, yet separate processes, influenced by specific child and parent characteristics, attitudes and experiences, characteristics of the research study, and research staff behaviors. The current study will be conducted during the last three years of funding of the Chicago HIV Prevention and Adolescent Mental Health Project (CHAMP-II) and will consist of a longitudinal study of 300 children and their adult caregivers that have been randomly assigned to one of the two study condition: CHAMP Family Intervention (n=150) or the control condition (n=150). Both children and their caregivers will be interviewed at three time intervals: 1) within one week after they have been solicited to participate in CHAMP-II; 2) at one year follow-up; 3) at two year follow-up. The proposed study is intended to achieve the following specific aims: 1) to examine factors that influence the extent to which 4th and 5th grade children and their adult caregivers are knowledgeable about the purpose of the study; clear about the expectations associated with participation and; accurate about the risks and benefits after these have been explained by staff; 2) to identify the factors that influenced adult caregivers to become initially involved in the study as well as to identify factors that caused adult caregivers concern about involving themselves or their children in CHAMP-II; 3) to examine factors that influence motivation to participate over the three years of the project across the experimental and control condition of the study; 4) to examine factors associated with drop out across the experimental and control conditions of the study. The current application reflects a combined effort of university-based researchers and community members. CHAMP-II is guided by a collaborative board, part of the investigative team for the proposed project, representing a partnership among community teachers and parents, researchers at the University of Illinois at Chicago and a community based mental health agency. The applicants believe that such active community input is necessary if we are to understand the processes of informed consent, initial and ongoing involvement in research activities from a low-income, African American perspective.
Public Health Relevance:
This Public Health Relevance is not available.Thesaurus Terms:
AIDS therapy, African American, child mental health service, informed consent, pediatric AIDS, urban poverty area
caregiver, child welfare, mental disorder prevention
adult human (19+), behavioral /social science research tag, clinical research, human subject, middle childhood (6-11)
Institution: UNIVERSITY OF ILLINOIS AT CHICAGO 310 AOB, M/C 672 CHICAGO, IL 60612 Fiscal Year: 1999 Department: PSYCHIATRY Project Start: 30-SEP-1997 Project End: 30-APR-2000 ICD: NATIONAL INSTITUTE OF MENTAL HEALTH IRG: ZRG2