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Trials / Completed

CompletedNCT04362475

Community Health Through Engagement and Environmental Renewal

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
915 (actual)
Sponsor
University of Alabama at Birmingham · Academic / Other
Sex
All
Age
11 Years
Healthy volunteers
Accepted

Summary

Community Health from Engagement and Environmental Renewal (CHEER) will leverage previous Centers for Disease Control and Prevention (CDC) community engagement projects to reach and intervene on a high need population. Disadvantage and poverty have long-term and transgenerational adverse impacts on social interaction and cohesion and residents' emotional and physical health. Mothers living and raising children in these conditions face multiple stressors without the community support previous generations relied on. Decades of research on American cities have connected the social, economic, and physical characteristics of neighborhoods with a lack of social cohesion, inability to maintain shared norms of acceptable behavior,and increases in health disparities and risky behaviors. Social cohesion and collective efficacy inversely associate with depression among youth. In a parallel manner, improved parenting practices and youth behavior directly associate with neighborhood social interactions and social cohesion. While these associations are suggestive, CHEER will directly test causal hypotheses at the neighborhood and family levels in a randomized control trial, that can significantly advance the evidence base for public health interventions: Family Youth Intervention (FYI) and an Environment: Social and Physical Intervention (ESPI) to increase social interaction, social cohesion, and collective efficacy and influence wellbeing of mothers and their youth.

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). 1. 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. 2. 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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALCommunity Health through Engagement and Environmental Renewal (CHEER)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.

Timeline

Start date
2021-05-21
Primary completion
2024-08-10
Completion
2025-09-01
First posted
2020-04-27
Last updated
2026-03-13
Results posted
2026-03-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04362475. Inclusion in this directory is not an endorsement.

Community Health Through Engagement and Environmental Renewal (NCT04362475) · Clinical Trials Directory