Clinical trial NCT04362475: Community Health Through Engagement and Environmental Renewal
Official title: Community Health Through Engagement and Environmental Renewal
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Family Relations
Blight
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2020-04-27
Enrollment: 779
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Hypotheses will be tested in a 2 X 2 design that includes the independent and combined effects of two interventions targeting the individual, family, and community level. Participating neighborhoods will be assigned into one of four cells: FYI alone, ESPI alone, FYI and ESPI combined, and Wait List Control.
Primary purpose: PREVENTION

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: A change in child behavior using the Child Behavior Checklist
timeFrame: Baseline, 6- and 18-month Follow-up
measure: Age of sexual initiation
timeFrame: Baseline
measure: Risky sex
timeFrame: Baseline
measure: Project on Human Development in Chicago Neighborhoods: Community Survey- Cohesion Index Subscale
timeFrame: Baseline
measure: Project on Human Development in Chicago Neighborhoods: Community Survey -Control Index
timeFrame: Baseline
measure: Project on Human Development in Chicago Neighborhoods: Community Survey- Dev13yr index
timeFrame: Baseline
measure: Social Contacts and Resources Scale
timeFrame: Baseline
Secondary outcomes:
measure: A change in emotional competence using the Social Emotional Competence Questionnaire
timeFrame: Baseline, 6- and 18-month Follow-up
measure: A change in communication using the Parent-child communication
timeFrame: Baseline, 6- and 18-month Follow-up
measure: A change is parental nurturance using the Parental Nurturance Scale
timeFrame: Baseline, 6- and 18-month Follow-up
measure: A change in family functioning using the Family Assessment Device
timeFrame: Baseline, 6- and 18-month Follow-up
measure: A change in coping with stress using the Cohen Perceived Stress Scale
timeFrame: Baseline, 6- and 18-month Follow-up
measure: A change in coping using the Coping Self-Efficacy Scale
timeFrame: Baseline, 6- and 18-month Follow-up
measure: A change in resilience using the Connor-Davidson Resilience Scale
timeFrame: Baseline, 6- and 18-month Follow-up
measure: A change in depression using The Center for Epidemiologic Studies Depression Scale
timeFrame: Baseline, 6- and 18-month Follow-up
measure: A change in social support using the Multidimensional Scale of Perceived Social Support
timeFrame: Baseline, 6- and 18-month Follow-up
measure: A change in quality of life using The World Health Organization Quality of Life Brief Scale
timeFrame: Baseline, 6- and 18-month Follow-up
measure: A change in how parents discipline using the Punitive Discipline Scale
timeFrame: Baseline, 6- and 18-month Follow-up
measure: A change in the level of parental monitoring using the Parental Monitoring Scale
timeFrame: Baseline, 6- and 18-month Follow-up
measure: A change in parenting stress using the Parenting Stress Index
timeFrame: Baseline, 6- and 18-month Follow-up
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Center for the Study of Community Health
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jeff T Walker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: National Bureau of Economic Research Working Paper 23395 http://www.nber.org/papers/w23395 (accessed 2018 Jan 27).
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citation: Aneshensel CS, Sucoff CA. The neighborhood context of adolescent mental health. J Health Soc Behav. 1996 Dec;37(4):293-310.
citation: Wilson, WJ. The truly disadvantaged. the inner city underclass and public policy. Chicago: University of Chicago Press; 1987.