Substance UseHARP-FNCT05253235
Health and Resilience Projects: Foundations
A study testing SAAF and Receipt of parenting book in people with Substance Use, run by University of Georgia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- SAAF and Receipt of parenting book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Youth:
- Self reported African American or Black;
- Age 10-13
- Parents:
- Primary caregiver for youth,
- Resides in same household as youth.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Family Research
Athens, Georgia, 30602
Cara Hodge, BS, 706-425-2992, thodge@uga.edu
About this study
Official title: Can Family-Centered Prevention Programming Reduce Neuroimmune Vulnerabilities for Drug Use and Cardiometabolic Risk Among African American Adolescents? A Randomized Prevention Trial
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.
Read the 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:
- 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;
- the mediating role of protective parenting in linking intervention participation to NIN-associated risk markers;
- 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
- 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.
- Conditions
- Substance Use
- Being tested
- SAAF, Receipt of parenting book
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAAFBehavioural
A 7 session online intervention designed to augment protective processes associated with deterrence of substance use
Receipt of parenting bookOther
Parents will receive a copy of the book, Parenting for Liberation: A Guide for Raising Black Children
| Study group | Role | What they receive |
|---|---|---|
| SAAF Intervention | Experimental | Parents and youth will receive an online, family-centered intervention consisting of 7 weekly sessions. Receives: Behavioral: SAAF |
| Control Group | Other | Control group members will receive a book entitled, Parenting for Liberation: A Guide for Raising Black Children Receives: Other: Receipt of parenting book |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Two years
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).
Measured: Two years
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).
Measured: Two years
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.
Measured: Two years
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.
Measured: Two years
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.
Measured: Two years
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.
Measured: Two Years
Secondary outcomes (10)
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: Two years
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.
Measured: Two years
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.
Measured: Two years
Peripheral inflammation composite score
Inflammatory signaling is assessed via a composite measure of circulating cytokines (Interleukin [IL]-6, 8, 10, tumor necrosis factor [TNF]-α) 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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start25 Jan 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to a preventive intervention or a no treatment control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gene H. Brody, University of Georgia
- Investigators
- Gene H Brody, Ph.D., Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253235
- Sponsor's protocol ID
- PROJECT00003530
- Acronym
- HARP-F
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in a specific article, after deidentification (text, tables, figures, and appendices), will be made available to qualified researchers, beginning 9 months after publication and ending 36 months after publication. Data will be shared with investigators whose proposed use of the data has been approved by a review committee designated for this purpose. Proposals should be directed to Gene Brody gbrody@uga.edu. To gain access, data requestors will need to sign a data access agreement.
Publications
Kogan SM, Yu T, Nusslock R, Cichoki AC, Seitz K, Beach SRH. Brain Structure and Differential Response to Family-Centered Prevention: Evidence for Anterior Cingulate Cortex Moderation in a Randomized Controlled Trial. Prev Sci. 2026 Oct 17. doi: 10.1007/s11121-026-01998-w. Online ahead of print.
PubMed 42891804Kogan SM, Anderson T, Yu T, Fisher S, Ahn SJG, Beach SRH. Behavioral Effects of a Telehealth Family Prevention Program for Black Adolescents: 2 Year Results of a Randomized Trial. J Prev (2022). 2026 Aug 1. doi: 10.1007/s10935-026-00939-1. Online ahead of print.
PubMed 42541642
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Family-Centered Prevention Programming Reduce Neuroimmune Vulnerabilities for Drug Use and Cardiometabolic Risk Among African American Adolescents? A Randomized Prevention Trial
- ClinicalTrials.gov ID
- NCT05253235
- Acronym / sponsor ID
- HARP-F / PROJECT00003530
- Conditions
- Substance Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- the mediating role of protective parenting in linking intervention participation to NIN-associated risk markers;
- 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
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to a preventive intervention or a no treatment control
| Arm | Type | Receives |
|---|---|---|
| SAAF Intervention | Experimental | Behavioral: SAAFParents and youth will receive an online, family-centered intervention consisting of 7 weekly sessions. |
| Control Group | Other | Other: Receipt of parenting bookControl group members will receive a book entitled, Parenting for Liberation: A Guide for Raising Black Children |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Self reported African American or Black;
- Age 10-13
- Primary caregiver for youth,
- Resides in same household as youth.
Key exclusion criteria (5 listed)
- 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).
- Conditions (e.g., severe disability, psychoses) that would prevent participation in the SAAF intervention or completing self-report measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAAFA 7 session online intervention designed to augment protective processes associated with deterrence of substance use | Behavioural | SAAF Intervention |
| Receipt of parenting bookParents will receive a copy of the book, Parenting for Liberation: A Guide for Raising Black Children | Other | Control Group |
Primary outcome
Self-regulation (youth report)
Time frame: Two years
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).
Self-regulation (parent report)
Time frame: Two years
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).
Tolerance for Deviance Scale
Time frame: Two years
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).
Reward-based eating
Time frame: Two years
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.
Substance use onset
Time frame: Two years
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.
Past 3 month substance use frequency
Time frame: Two years
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.
Unhealthy eating
Time frame: Two Years
Youth will complete the Adolescent Food Habits checklist. Items are summed. We expect SAAF youth to engage in less unhealthy eating than control youth.
10 secondary outcomes
Involved Vigilant Parenting Scale (youth report)
Time frame: 1 year
Involved Vigilant Parenting (parent report)
Time frame: 1 year
Cultural socialization (youth report)
Time frame: 1 year
Cultural socialization (parent report)
Time frame: 1 year
Communication about Risk Behavior (youth report)
Time frame: 1 year
Communication about risk behavior (parent report)
Time frame: 1 year
Threat sensitivity via functional MRI assessment
Time frame: Two years
Executive control assessed via functional MRI assessment
Time frame: Two years
Reward sensitivity via functional MRI assessment
Time frame: Two years
Peripheral inflammation composite score
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Derived from this study: PubMed 42891804Kogan SM, Yu T, Nusslock R, Cichoki AC, Seitz K, Beach SRH. Brain Structure and Differential Response to Family-Centered Prevention: Evidence for Anterior Cingulate Cortex Moderation in a Randomized Controlled Trial. Prev Sci. 2026 Oct 17. doi: 10.1007/s11121-026-01998-w. Online ahead of print.
- Derived from this study: PubMed 42541642Kogan SM, Anderson T, Yu T, Fisher S, Ahn SJG, Beach SRH. Behavioral Effects of a Telehealth Family Prevention Program for Black Adolescents: 2 Year Results of a Randomized Trial. J Prev (2022). 2026 Aug 1. doi: 10.1007/s10935-026-00939-1. Online ahead of print.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in a specific article, after deidentification (text, tables, figures, and appendices), will be made available to qualified researchers, beginning 9 months after publication and ending 36 months after publication. Data will be shared with investigators whose proposed use of the data has been approved by a review committee designated for this purpose. Proposals should be directed to Gene Brody gbrody@uga.edu. To gain access, data requestors will need to sign a data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gene H Brody, Ph.D. principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAAF and Receipt of parenting book in people with Substance Use, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Zuercher, MPH (706-425-2992, zuercher@uga.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-regulation (youth report) (time frame: Two years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05253235, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.