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De klinische studie NCT05253235 (HARP-F) voor Middelengebruik is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Health and Resilience Projects: Foundations (HARP-F) 650 Adolescenten
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De klinische studie NCT05253235 (HARP-F) is een interventioneel studie bij Middelengebruik met de status rekruterend. Het doel is om 650 deelnemers te includeren vanaf 25 januari 2022. De studie wordt geleid door de Universiteit van Georgia en de voltooiing is gepland op 31 december 2027. Laatste update op ClinicalTrials.gov: 23 februari 2022.
Beknopte samenvatting
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 bas...Toon meer
Uitgebreide beschrijving
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...Toon meer
Officiële titel
Can Family-Centered Prevention Programming Reduce Neuroimmune Vulnerabilities for Drug Use and Cardiometabolic Risk Among African American Adolescents? A Randomized Prevention Trial
Aandoeningen
MiddelengebruikAndere studie-ID's
- HARP-F
- PROJECT00003530
NCT-ID
Startdatum (Werkelijk)
2022-01-25
Laatste update geplaatst
2022-02-23
Verwachte einddatum
2027-12-31
Inschrijving (Geschat)
650
Studietype
Interventioneel
FASE
N.v.t.
Status
Rekruterend
Primaire doel
Preventie
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Enkelblind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelSAAF Intervention Parents and youth will receive an online, family-centered intervention consisting of 7 weekly sessions. | SAAF A 7 session online intervention designed to augment protective processes associated with deterrence of substance use |
OverigeControl Group Control group members will receive a book entitled, Parenting for Liberation: A Guide for Raising Black Children | Receipt of parenting book Parents will receive a copy of the book, Parenting for Liberation: A Guide for Raising Black Children |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
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 |
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 |
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 |
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 |
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 |
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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. | Two years |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Kind
Minimumleeftijd
10 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
Youth:
- Self reported African American or Black;
- Age 10-13
Parents:
- Primary caregiver for youth,
- Resides in same household as youth.
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.
Verantwoordelijke instantie
Gene H. Brody, Hoofdonderzoeker, Regents Professor, University of Georgia
Centraal Contactpersoon
Contact: Heather Zuercher, MPH, 706-425-2992, [email protected]
Contact: Cara Hodge, BS, 706-425-2992, [email protected]
1 Studielocaties in 1 landen
Georgia
Center for Family Research, Athens, Georgia, 30602, United States
Cara Hodge, BS, Contact, 706-425-2992, [email protected]
Rekruterend