- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04362475
Community Health Through Engagement and Environmental Renewal (CHEER)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim 1 Family System: To test the effect of FYI on primary outcomes of youth psychosocial behaviors and sexual risk compared to a Wait List Control.
1a. FYI will significantly improve our primary outcomes of externalizing (e.g. impulsivity, violence, theft) and internalizing (e.g. depression, withdrawal, anxiety, loneliness) behaviors and early and risky sex (i.e. sexual initiation at less than 16 years of age and sexual intercourse without a condom) (Effectiveness).
b. FYI will significantly lower parental stress, improve maternal emotional health, enhance parenting skills and improve youth Social and Emotional Competence (SEC) to change primary outcomes (Mediation).
Aim 2 Community System: To test the effect of ESPI on neighborhood environment compared to Wait List Control.
- a. ESPI significantly will increase our primary outcomes of social interaction, social cohesion, collective efficacy, and shared norms compared to wait list control (Effectiveness).
2b. Engaging residents in community-designed and -led projects to develop common spaces will significantly improve neighborhood perceptions (e.g. attractiveness, safety) and provide opportunities for residents to interact to change primary outcomes (Mediation).
Aim 3 Community and Family Systems: To test the effects of combining FYI and ESPI on the same youth and neighborhood environmental outcomes as in Aims 1 and 2 compared to FYI alone, ESPI alone, and a Wait List Control.
3a. ESPI and FYI will significantly reduce primary youth and neighborhood environmental outcomes (Effectiveness).
3b. ESPI and FYI will change neighborhood environmental and family processes to change primary outcomes of adolescent SEC, external and internal behaviors, and early and risky sex (Mediation).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- UAB Center for the Study of Community Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- For FYI, parents who reside in the FYI intervention neighborhood (North Titusville, South Titusville, Rising -West Princeton, and Belview Heights) and have a child age 11-16 years.
- For ESPI, residents who live in the ESPI intervention neighborhoods (North Titusville, South Titusville, Druid Hills, and Fountain Heights).
Exclusion Criteria:
- For FYI, does not met the above requirements and did not consent to participate.
- For ESPI, not residing in one of the above neighborhoods and did not consent to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Family Youth Intervention (FYI)
The primary objective of FYI is to evaluate the effectiveness of a theory-based, peer-supported family strengthening intervention on the primary outcomes in a sample of 120 parent-child pairs living in resource-poor urban neighborhoods in Birmingham.
For FYI, we will utilize community health advisors (CHAs) to implement the intervention.
CHAs will be recruited from each FYI neighborhood and will be trained in research ethics.
CHAs will assist and support FYI participants in mastering the sequential skills of the 12 modules designed to improve maternal, youth, and family functioning.
Additionally, CHAs will provide emotional social support that is helpful, hopeful, and trustful.
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FYI and ESPI intervention activities will be implemented in the overall study, CHEER.
It will also allow us to examine possible synergistic effects of both interventions when implemented in the same neighborhoods.
Separate sets of participants will be selected for the FYI comparisons and for the ESPI comparisons.
Because the FYI intervention focuses on mothers and their children, participants for the FYI comparisons will be selected by Respondent Driven Sampling of eligible families from the neighborhoods in all four cells.
The ESPI intervention targets the whole neighborhood, and thus a random sample of neighborhood residents will be enrolled in each of the four cells.
Because the primary outcomes for FYI and ESPI are connected but differ from each other, the FYI samples will be assessed for the FYI outcomes in all four cells and the ESPI samples will be assessed for the ESPI outcomes in all four cells.
Other Names:
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Active Comparator: ESPI Environment: Social and Physical Intervention (ESPI)
ESPI will enroll 500 community members to examine the effect of blight elimination through lot recovery on primary outcomes of improved social interaction, social cohesion around common neighborhood norms, and collective efficacy to effect change in the neighborhoods .
Neighborhood residents will select a cluster of lots (2-3) for lot recovery that are highly visible in the neighborhood (e.g. on a main thoroughfare).
The community residents will lead the neighborhood projects.
In some cases, neighborhood residents will personally undertake all or part of the greening projects.
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FYI and ESPI intervention activities will be implemented in the overall study, CHEER.
It will also allow us to examine possible synergistic effects of both interventions when implemented in the same neighborhoods.
Separate sets of participants will be selected for the FYI comparisons and for the ESPI comparisons.
Because the FYI intervention focuses on mothers and their children, participants for the FYI comparisons will be selected by Respondent Driven Sampling of eligible families from the neighborhoods in all four cells.
The ESPI intervention targets the whole neighborhood, and thus a random sample of neighborhood residents will be enrolled in each of the four cells.
Because the primary outcomes for FYI and ESPI are connected but differ from each other, the FYI samples will be assessed for the FYI outcomes in all four cells and the ESPI samples will be assessed for the ESPI outcomes in all four cells.
Other Names:
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Other: Wait-List Control
The two communities will get ESPI, upon completion of the study.
|
FYI and ESPI intervention activities will be implemented in the overall study, CHEER.
It will also allow us to examine possible synergistic effects of both interventions when implemented in the same neighborhoods.
Separate sets of participants will be selected for the FYI comparisons and for the ESPI comparisons.
Because the FYI intervention focuses on mothers and their children, participants for the FYI comparisons will be selected by Respondent Driven Sampling of eligible families from the neighborhoods in all four cells.
The ESPI intervention targets the whole neighborhood, and thus a random sample of neighborhood residents will be enrolled in each of the four cells.
Because the primary outcomes for FYI and ESPI are connected but differ from each other, the FYI samples will be assessed for the FYI outcomes in all four cells and the ESPI samples will be assessed for the ESPI outcomes in all four cells.
Other Names:
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Active Comparator: FYI and ESPI
Two of the eight neighborhoods will receive both FYI and ESPI intervention.
|
FYI and ESPI intervention activities will be implemented in the overall study, CHEER.
It will also allow us to examine possible synergistic effects of both interventions when implemented in the same neighborhoods.
Separate sets of participants will be selected for the FYI comparisons and for the ESPI comparisons.
Because the FYI intervention focuses on mothers and their children, participants for the FYI comparisons will be selected by Respondent Driven Sampling of eligible families from the neighborhoods in all four cells.
The ESPI intervention targets the whole neighborhood, and thus a random sample of neighborhood residents will be enrolled in each of the four cells.
Because the primary outcomes for FYI and ESPI are connected but differ from each other, the FYI samples will be assessed for the FYI outcomes in all four cells and the ESPI samples will be assessed for the ESPI outcomes in all four cells.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Problem Behaviors in Children Ages 11 to 16 Years.
Time Frame: Baseline, 1-week and 6-month Follow-up
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Three items asked have the child ever been suspended from school and within the past 12 months prior to the baseline survey have they smoked cigarettes or drunk alcohol.
Participants choose 1 for yes and 0 for no.
The range is form 0 to 3, where 3 describes a higher problematic behavior.
Three questions were asked at 1-week and 6 month follow-up: have they been suspended from school, smoked cigarettes or drunk alcohol since baseline.
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Baseline, 1-week and 6-month Follow-up
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Age of Sexual Initiation
Time Frame: Baseline
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Year of age at sex.
Two variables were used to measure sexual initiation.
Answer choices ranged continuously from 1 (10 years old) to 9 (18 years or older).
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Baseline
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Number of Participants Who Participates in Risky Sex
Time Frame: Baseline
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Follow-up questions for individuals endorsing sexual initiation to assess risky sex behavior.
The count was assessed on how often did the participant had sex without a condom.
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Baseline
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Project on Human Development in Chicago Neighborhoods: Community Survey- Cohesion Index Subscale
Time Frame: Baseline, 12-month Follow up 1 and 18-month Follow up 2
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Project on Human Development in Chicago Neighborhoods: Community Survey assesses city-level variables relating to neighborhood structure.
This scale consisted of 7 items that were measured on a scale of 1 to 6.
The range of scores are from 7 to 35.
The mean score was analyzed where the higher the score the community interaction was the worst.
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Baseline, 12-month Follow up 1 and 18-month Follow up 2
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Number of Participants Who Like Living in Their Neighborhood
Time Frame: Baseline
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Survey item on whether they like or dislike living their neighborhood.
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Baseline
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Project on Human Development in Chicago Neighborhoods: Community Survey- Neighborhood Perception
Time Frame: Baseline, 12-month Follow up and 18-month Follow-up
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Project on Human Development in Chicago Neighborhoods: Community Survey assesses city-level variables relating to neighborhood structure.
Three items on a scale of 1 to 6, were used to measure how participants perceive their neighborhood.
The range of the scores were from 3 to 12.
The mean score was analyzed where the higher the score is a better overall perception of their neighborhood.
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Baseline, 12-month Follow up and 18-month Follow-up
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Social Contacts and Resources Scale
Time Frame: Baseline, 12- month Follow up 1, and 18-month Follow up 2
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Social Contacts and Resources Scale, a 5-item measure of social activities with their neighbors.
Responses ranged from 1 (never) to 4 (often).
a total mean score were derived where higher scores indicating greater social contact.
The scores range from 5 to 20.
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Baseline, 12- month Follow up 1, and 18-month Follow up 2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Parent-Adolescent Communication
Time Frame: Baseline, 1-week and 6-month follow up
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This is a 20-item scale where response choices range from 1= Strongly Disagree to 5= Strongly Agree.
Items are summed to arrive at a total communication score (range 20-100), with higher scores suggesting better overall communication quality.
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Baseline, 1-week and 6-month follow up
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Parental Nurturance
Time Frame: Baseline, 1-week and 6-month follow up
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Measured using using a single item, " I get the emotional help and support I need from my family."
The responses to the item is on a 7-point likert scale ranging from Very Strongly Agree to Very Strongly Disagree where Very Strongly Disagree describes a less nurturing parent and Very Strongly Agree describes more nurturance the parent displays.
Scores ranged from 1 to 7.
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Baseline, 1-week and 6-month follow up
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Family Functioning
Time Frame: Baseline, 1-week and 6-month follow up
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American Strength Inventory was uses six categories to measure the strength of a family.
Participants responded with Not true (1), Sometimes true (2) and Often true (3).
The items were added for a total family strength score where a mean score was analyzed.
The subscale Global Measure was used to measure family functioning.
The scores range from 4 to 12, where the higher the score the higher the family functioning.
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Baseline, 1-week and 6-month follow up
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Coping
Time Frame: Baseline, 1-week and 6-month follow up
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Measured using the Managing Stress and Crisis Effectively subscale of the American Family Strength Inventory assess family functioning and qualities that makes a family strong.
Participants responded with Not true (1), Sometimes true (2) and Often true (3).
The scores ranged from 6 to 24.
The items were added for a total family strength score where a mean score was analyzed.
Higher mean scores means higher coping with stress skills.
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Baseline, 1-week and 6-month follow up
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Perceived Depression
Time Frame: Baseline, 1-week and 6-month follow up
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The Patient Health Questionnaire Scale (PHQ-9) is a abbreviated scale that measures self-report depressive symptoms.
Respondents report on a 4-point likert scale where 0 is Not at All and 3 is Nearly Everyday.
Items were added to determine the presence and severity of depressive symptoms.
The range of the scores are 0 to 27.
Score interpretations are 1-4 Minimal depression, 5-9 Mild depression, 10-14 Moderate depression,15-19 Moderately severe depression, and 20-27 Severe depression.
A mean score was analyzed.
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Baseline, 1-week and 6-month follow up
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Social Support
Time Frame: Baseline, 1-week and 6-month follow up
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Measured using items from the World Health Organization's Quality of Life Questionnaire to measure satisfaction with the level of social support they receive.
The responses were on a 5-point likert scale ranging from very dissatisfied (1) to very satisfied (5).
The higher the score the more scarification with their social support.
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Baseline, 1-week and 6-month follow up
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The World Health Organization Quality of Life Brief Scale
Time Frame: Baseline, 1-week and 6-month follow up
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The World Health Organization Quality of Life Brief Scale measures four domains of quality of life: physical health, psychological, social relations and environment.
The scores are transformed on a scale from 0 to 100 where higher score mean higher quality of life.
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Baseline, 1-week and 6-month follow up
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Punitive Discipline Scale
Time Frame: Baseline, 1-week and 6-month follow up
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Punitive discipline is assessed using four items that indicate the frequency of spanking/hitting, scolding, and threatening to spank/hit or threatening to punish.
Response categories included 1 = never in past 12 months; 2 = a few times; 3 = once a month or more; 4 = once a week or more; and, 5 = almost everyday.
After totaling the score, the higher the score the more the parent uses punitive discipline.
Scores range from 4 to 20 where the higher the score the more often the parent used punitive discipline.
A mean score was analyzed.
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Baseline, 1-week and 6-month follow up
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Parental Monitoring Scale
Time Frame: Baseline, 1-week and 6-month follow up
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Adolescents reported how often their parents knew where they were and what they were doing after school, on weeknights, and on weekends.
All items used a 4-point scale ranging from 1 (almost never), to 2 (sometimes), to 3 (usually), to 4 (almost always).
Scores ranging from 1 (low levels of parental monitoring) to 4 (high levels of parental monitoring).
The range of the scores are 7-28.
After totaling the score, the higher the score the higher levels of parental monitoring were present.
A mean score was analyzed.
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Baseline, 1-week and 6-month follow up
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jeff T Walker, PhD, University of Alabama at Birmingham
Publications and helpful links
General Publications
- Collins WJ, Wanamaker MH. Up from slavery? Black intergenerational economic mobility since 1880.
- National Bureau of Economic Research Working Paper 23395 http://www.nber.org/papers/w23395 (accessed 2018 Jan 27).
- Shaw CR, McKay HD. Juvenile delinquency and urban areas. Chicago: University of Chicago Press; 1943.
- Aneshensel CS, Sucoff CA. The neighborhood context of adolescent mental health. J Health Soc Behav. 1996 Dec;37(4):293-310.
- Wilson, WJ. The truly disadvantaged. the inner city underclass and public policy. Chicago: University of Chicago Press; 1987.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 300004617
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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