NCT02647710

Brief Summary

PHAT Life: Preventing HIV/AIDS Among Teens, is a uniquely-tailored intervention designed for recently-arrested juvenile offenders on probation. The program will teach teens about HIV/AIDS, sexually transmitted infections, and safer decision-making. The PHAT Life Research Study is a 2-arm randomized controlled trial of the PHAT Life Intervention. The investigators will test and compare PHAT Life to the health promotion control group on adolescent risky sexual behavior, substance use, and theoretical mediators.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2010

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

6.1 years

First QC Date

December 29, 2015

Last Update Submit

April 30, 2018

Conditions

Keywords

HIV PreventionJuvenile JusticeSexual HealthEvidence Based Intervention

Outcome Measures

Primary Outcomes (1)

  • Change in HIV/STI Risk Behaviors at 6 and 12 months

    AIDS Risk Behavior Assessment (ARBA) A computer-assisted structured interview of self-reported sexual behavior and drug use derived from five well-established measures. The outcomes include ever had sex, condom use, number of partners, sex while using drugs and/or alcohol.

    baseline, 6-months, and 12--months

Secondary Outcomes (11)

  • Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6 and 12 months

    Baseline, 6-months, and 12-months

  • Change in mental health symptoms at 6 and 12 months

    Baseline, 6-months, and 12-months

  • Change in Partner Sexual Communication at 6 and 12 months

    Baseline, 6-months, and 12-months

  • Change in Relationship dynamics at 6 and 12 months

    Baseline, 6-months, and 12-months

  • Change in trauma symptoms and violence exposure at 6 and 12 months

    Baseline, 6-months, and 12-months

  • +6 more secondary outcomes

Study Arms (2)

PHAT Life Intervention

EXPERIMENTAL

PHAT Life: Preventing HIV/AIDS Among Teens, is a uniquely-tailored intervention designed for recently-arrested juvenile offenders on probation. The program will teach teens about HIV/AIDS, sexually transmitted infections, and safer decision-making. PHAT Life draws on social learning theory and a Social-Personal Framework to address individual and social mechanisms related to HIV-risk, including emotion regulation, peer norms, partner communication, relationship characteristics, and HIV/AIDS/STI and substance use knowledge, attitudes, and beliefs.

Behavioral: PHAT Life Intervention

Health Promotion Control

ACTIVE COMPARATOR

A health promotion program focusing on nutrition, physical activity, substance use, and sexual health.

Behavioral: Health Promotion Control

Interventions

HIV Prevention behavioral health intervention

PHAT Life Intervention

Behavioral health intervention control

Health Promotion Control

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • male or female gender
  • placed on probation following arrest
  • remanded to a probation program
  • years old
  • both adolescent and parent are fluent English speakers
  • not a ward of the state (DCFS Ward).

You may not qualify if:

  • are unable to understand the consent/assent process
  • do not speak English, because instruments are normed for English speakers
  • do not assent; d) legal guardians do not consent to teens' participation
  • are not 13 -17 years old
  • are not on probation or remanded to a probation program
  • are Wards of the state (DCFS Ward)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (5)

  • Donenberg GR, Emerson E, Mackesy-Amiti ME, Udell W. HIV-Risk Reduction with Juvenile Offenders on Probation. J Child Fam Stud. 2015 Jun 1;24(6):1672-1684. doi: 10.1007/s10826-014-9970-z.

    PMID: 26097376BACKGROUND
  • Udell W, Donenberg G, Emerson E. Parents matter in HIV-risk among probation youth. J Fam Psychol. 2011 Oct;25(5):785-9. doi: 10.1037/a0024987.

    PMID: 21875199BACKGROUND
  • Wilson HW, Berent E, Donenberg GR, Emerson EM, Rodriguez EM, Sandesara A. Trauma History and PTSD Symptoms in Juvenile Offenders on Probation. Vict Offender. 2013;8(4):10.1080/15564886.2013.835296. doi: 10.1080/15564886.2013.835296.

    PMID: 24273468BACKGROUND
  • Donenberg G, Emerson E, Kendall AD. HIV-risk reduction intervention for juvenile offenders on probation: The PHAT Life group randomized controlled trial. Health Psychol. 2018 Apr;37(4):364-374. doi: 10.1037/hea0000582. Epub 2018 Feb 1.

  • Kendall AD, Emerson EM, Hartmann WE, Zinbarg RE, Donenberg GR. A Two-Week Psychosocial Intervention Reduces Future Aggression and Incarceration in Clinically Aggressive Juvenile Offenders. J Am Acad Child Adolesc Psychiatry. 2017 Dec;56(12):1053-1061. doi: 10.1016/j.jaac.2017.09.424. Epub 2017 Oct 5.

Study Officials

  • Geri Donenberg, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean of Research, Professor

Study Record Dates

First Submitted

December 29, 2015

First Posted

January 6, 2016

Study Start

June 15, 2010

Primary Completion

July 15, 2016

Study Completion

December 31, 2017

Last Updated

May 3, 2018

Record last verified: 2018-04

Locations