Health and Resilience Projects: Foundations

Substance Use Clinical Trial

— HARP-F  

Official title:

Can Family-Centered Prevention Programming Reduce Neuroimmune Vulnerabilities for Drug Use and Cardiometabolic Risk Among African American Adolescents? A Randomized Prevention Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05253235
• Other study ID #: PROJECT00003530
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2022
• Source: University of Georgia
• Contact: Heather Zuercher, MPH
• Phone: 706-425-2992
• Email: zuercher[@]uga.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (e.g., metal in body, traumatic brain injury, claustrophobia, pregnancy), (b) youth with chronic illnesses or medication regimens that would affect inflammatory panels (e.g., diabetes, congenital heart disease, asthma, cancers), and (c) parent or youth conditions (e.g., 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 2.5-year period to obtain a sample of 325 families. Eligible participants will be scheduled for an assessment at UGA's 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 children's 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

Inclusion Criteria:

Youth:

• Self reported African American or Black;

• Age 10-13

Parents:

• Primary caregiver for youth,

• Resides in same household as youth.

Exclusion Criteria:

Youth :

• Contraindications for MRI scanning (e.g., metal in body, traumatic brain injury, claustrophobia, pregnancy),

• Youth with chronic illnesses or medication regimens that would affect inflammatory panels (e.g., diabetes, congenital heart disease, asthma, cancers).

Parent:

• Conditions (e.g., severe disability, psychoses) that would prevent participation in the SAAF intervention or completing self-report measures.

Related Conditions & MeSH terms

• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• SAAF
A 7 session online intervention designed to augment protective processes associated with deterrence of substance use

Other:
• Receipt of parenting book
Parents will receive a copy of the book, Parenting for Liberation: A Guide for Raising Black Children

Locations

Country	Name	City	State
United States	Center for Family Research	Athens	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-regulation (youth report)	Youth will complete the the Future-oriented Goals scale and Will's Self-Control scale. We will standardize scores from these two measures (mean =0, standard deviation =1) then average them together. We expect assignment to SAAF vs control to be associated with higher scores (more self-regulation).	Two years
Primary	Self-regulation (parent report)	Parents will complete a 12 item scale (Humphrey's self control scale) about their youth. Items will be summed ranging from 0-36. We expect assignment to SAAF vs control to be associated with higher scores (more self-regulation).	Two years
Primary	Tolerance for Deviance Scale	Youth will complete the Tolerance for Deviance scale. 19 Items are summed, ranging from 0-57. We expect assignment to SAAF vs Control to be associated with lower scores (reductions in risky attitudes).	Two years
Primary	Reward-based eating	Youth will complete the 13 items Reward Based Eating Drive scale. Scores range from 13-65. SAAF youth are expected to have lower scores on reward based eating compared to control youth.	Two years
Primary	Substance use onset	Lifetime use (yes or no) of alcohol, marijuana, or cigarettes per youth self-report. We will sum the items to form a composite onset index. We expect youth assigned to SAAF to report less substance use onset than youth assigned to control.	Two years
Primary	Past 3 month substance use frequency	Youth complete likert type items assessing alcohol, marijuana, and nicotine use in the past 3 months. Items are standardized and summed to form a substance use composite. We expect youth assigned to SAAF to report less substance use than youth assigned to control.	Two years
Primary	Unhealthy eating	Youth will complete the Adolescent Food Habits checklist. Items are summed. We expect SAAF youth to engage in less unhealthy eating than control youth.	Two Years
Secondary	Involved Vigilant Parenting Scale (youth report)	Youth report on the 17 item Involved Vigilant Parenting scale. Items are summed to indicate higher scores on effective parenting, ranging from 17-85. We expect SAAF youth to report more involved vigilant parenting than control youth.	1 year
Secondary	Involved Vigilant Parenting (parent report)	Parents report on the 17 item Involved Vigilant Parenting scale. Items are summed to indicate higher scores on effective parenting, ranging from 17-85. We expect SAAF parents to report more involved vigilant parenting than control parents.	1 year
Secondary	Cultural socialization (youth report)	Youth report on the cultural socialization subscale of the Racial Socialization Scale. Five items (range is 5-25) are summed to indicate higher scores on cultural socialization. We expect SAAF youth to report more cultural socialization than control youth.	1 year
Secondary	Cultural socialization (parent report)	Caregivers report on the cultural socialization subscale of the Racial Socialization Scale. Five items (range is 5-25) are summed to indicate higher scores on cultural socialization. We expect SAAF parents to report more cultural socialization than control parents.	1 year
Secondary	Communication about Risk Behavior (youth report)	Youth report on Discussion Quality scale. Three items are summed to indicate higher scores on communication (range 0-12). We expect SAAF youth to report more harmonious communication than control youth.	1 year
Secondary	Communication about risk behavior (parent report)	Parents report on the Discussion Quality scale. Three items are summed to indicate higher scores on communication (range 0-12). We expect SAAF parents to report more harmonious communication than control parents.	1 year
Secondary	Threat sensitivity via functional MRI assessment	Threat sensitivity is assessed via amygdalar activity during a threat paradigm. We expect assignment to SAAF to be associated with diminished amygdalar reactivity to threat stimuli.	Two years
Secondary	Executive control assessed via functional MRI assessment	We will use multivariate autoregressive modeling to generate parameter estimates of functional connectivity within cortico-amygdalar and cortico-striatal circuitry during the reward task. We focus on a seed-to-seed association between the orbital frontal cortext (OFC) and the ventral striatum (VS). Here, a positive (i.e., > 0) parameter estimate reflects strong executive control over the VS during reward processing. Conversely, a negative parameter estimate (i.e., < 0) suggests the youth is engaging the OFC in a manner that down-regulates sub-cortical reward processing.	Two years
Secondary	Reward sensitivity via functional MRI assessment	Neural activity associated with processing rewarding stimuli using fMRI data. We predict that assignment to SAAF will reduce deficits in reward sensitivity as assessed by ventral striatum activity during a reward task.	Two years
Secondary	Peripheral inflammation composite score	Inflammatory signaling is assessed via a composite measure of circulating cytokines (Interleukin [IL]-6, 8, 10, tumor necrosis factor [TNF]-a) and C-reactive protein (CRP). Per past research, we will standardize the values for each biomarker and then sum them to form a composite score ranging from 0-5. A higher score on this composite reflects more low-grade inflammation.	Two years