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Health and Resilience Projects: Foundations

ConditionSubstance Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-13
SponsorUniversity of Georgia

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Self reported African American or Black;

Age 10-13

Primary caregiver for youth,

Resides in same household as youth.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SAAF

    Behavioral

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

  • Receipt of parenting book

    Other intervention

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

Treatment groups

650 Participants
are divided into 2 treatment groups
Group A: SAAF InterventionExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Two years
2

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).

Time frame
Two years
3

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).

Time frame
Two years
4

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.

Time frame
Two years

Secondary outcomes

1

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.

Time frame
1 year
2

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.

Time frame
1 year
3

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.

Time frame
1 year
4

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

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University of Georgia

Lead sponsor

Source ClinicalTrials.gov
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