Ignite Creation Date:
2024-05-06 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05253235
Status:
RECRUITING
Last Update Posted:
2022-02-23
First Post:
2022-02-01
Brief Title:
Health and Resilience Projects Foundations
Sponsor:
University of Georgia
Organization:
University of Georgia
Study Overview
Official Title:
Can Family-Centered Prevention Programming Reduce Neuroimmune Vulnerabilities for Drug Use and Cardiometabolic Risk Among African American Adolescents A Randomized Prevention Trial
Status:
RECRUITING
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HARP-F
Brief Summary:
The Health and Resilience Project HARP Foundations is investigating the efficacy of the Strong African American Families SAAF intervention in promoting the health and well being of African American adolescents Youth age 10-13 and their primary caregivers are randomly assigned to receive SAAF or to a control group Participants complete baseline and follow-up measures regarding vulnerability to substance use based on a neuroimmune model of stress coping
Detailed Description:
During childhood and adolescence family relationships play critical roles in regulating physiological stress reactions This protects the developing brain from the potentially deleterious effects of stress hormones and neurochemicals In a series of proof-of-principle studies the investigators studied the potential for the Strong African American Families SAAF drug use prevention program delivered when youth were age 11 to protect participants from the consequences of social adversity when they were transitioning to adulthood ages 19-25 Effects were detected on a range of outcomes associated with neuroimmune NIN dysregulation including inflammation the neural structure of limbic regions prefrontal-limbic connectivity and cardiometabolic health Although these findings are provocative the SAAF trial was not designed to evaluate mechanisms and outcomes that the NIN model suggested Data on inflammation and neural activity were collected post hoc many years after the intervention concluded Thus these findings must be regarded as preliminary until a more rigorous study is performed with pretest and posttest measures of NIN processes The proposed prevention trial of SAAF N 325 is designed to meet this need
Our specific aims are to test hypotheses regarding
1 the influence of participation in SAAF on change in NIN-associated risk markers neural circuitry subserving threat reward and executive control as well as peripheral inflammation across 2 years
2 the mediating role of protective parenting in linking intervention participation to NIN-associated risk markers
3 the influence of participation in SAAF on change in addictive behavior vulnerabilities associated with risky decision making emotion regulation early-onset substance use unhealthy eating and cardiometabolic risk markers and
4 the mediational chain linking SAAF to addictive behavior vulnerabilities via changes in parenting and NIN-associated risk markers
A sample of 325 African American youth and their primary caregivers will be recruited from Athens GA and surrounding areas Inclusion criteria are a youth or parent self-designates as African American Black or biracial including Black or African American and b youth is in 5th grade and 10-13 years of age Exclusion criteria include a contraindications for MRI scanning eg metal in body traumatic brain injury claustrophobia pregnancy b youth with chronic illnesses or medication regimens that would affect inflammatory panels eg diabetes congenital heart disease asthma cancers and c parent or youth conditions eg ADHD psychoses that would prevent participation in the SAAF intervention Given the nonverbal nature of fMRI tasks left-handed youth are not excluded The investigators anticipate screening 615 families over a 25-year period to obtain a sample of 325 families Eligible participants will be scheduled for an assessment at UGAs Bioimaging Research Center Youth will participate in a scan 60 minutes a blood draw and youth and parents will complete self-report measures At each data collection wave parents consent in writing to their own and their childrens participation and children provide written assent At W2 a home visit is made with laptop computers to collect self-report data After pretest families will be assigned randomly to SAAF or control Control families receive written information by mail regarding adolescent development
Our specific aims are to test hypotheses regarding
1 the influence of participation in SAAF on change in NIN-associated risk markers neural circuitry subserving threat reward and executive control as well as peripheral inflammation across 2 years
2 the mediating role of protective parenting in linking intervention participation to NIN-associated risk markers
3 the influence of participation in SAAF on change in addictive behavior vulnerabilities associated with risky decision making emotion regulation early-onset substance use unhealthy eating and cardiometabolic risk markers and
4 the mediational chain linking SAAF to addictive behavior vulnerabilities via changes in parenting and NIN-associated risk markers
A sample of 325 African American youth and their primary caregivers will be recruited from Athens GA and surrounding areas Inclusion criteria are a youth or parent self-designates as African American Black or biracial including Black or African American and b youth is in 5th grade and 10-13 years of age Exclusion criteria include a contraindications for MRI scanning eg metal in body traumatic brain injury claustrophobia pregnancy b youth with chronic illnesses or medication regimens that would affect inflammatory panels eg diabetes congenital heart disease asthma cancers and c parent or youth conditions eg ADHD psychoses that would prevent participation in the SAAF intervention Given the nonverbal nature of fMRI tasks left-handed youth are not excluded The investigators anticipate screening 615 families over a 25-year period to obtain a sample of 325 families Eligible participants will be scheduled for an assessment at UGAs Bioimaging Research Center Youth will participate in a scan 60 minutes a blood draw and youth and parents will complete self-report measures At each data collection wave parents consent in writing to their own and their childrens participation and children provide written assent At W2 a home visit is made with laptop computers to collect self-report data After pretest families will be assigned randomly to SAAF or control Control families receive written information by mail regarding adolescent development
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None