NCT02141646

Brief Summary

This is a randomized controlled trial to contrast an intervention that relies on well-developed cognitive control systems (Motivational Interviewing; MI) to an intervention that relies on a more basic response to scheduled reward (Behavioral Skills Training; BST).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

3.8 years

First QC Date

March 4, 2014

Last Update Submit

March 11, 2024

Conditions

Keywords

HIV/AIDS, motivational interviewing, behavioral skills training, MRI

Outcome Measures

Primary Outcomes (1)

  • Change in risky sexual behaviors

    Behavioral follow-up measures completed 3 and 6 months post-intervention.

Study Arms (2)

Motivational interviewing

EXPERIMENTAL
Behavioral: Motivational Interviewing

Behavioral skills training

EXPERIMENTAL
Behavioral: Behavioral Skills Training

Interventions

The main goals of motivational interviewing are to engage clients, elicit change talk, and evoke motivation to make positive changes from the client.

Motivational interviewing

Behavioral Skills Training (BST) is a training package that utilizes instructions, modeling, rehearsal, and feedback in order to teach a new skill.

Behavioral skills training

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • participating in the youth reporting center;
  • be aged 14 to 18;
  • be proficient in English
  • consent to be re-contacted 3 and 6 months post-intervention;
  • must have the fully informed consent of a parent or legal guardian;
  • must give their personal fully informed assent to participate.

You may not qualify if:

  • History of brain injury or brain related medical problems;
  • Currently on any psychotropic medications (e.g., neuroleptics, anticonvulsants);
  • Female subjects must not be pregnant (as indicated by a negative pregnancy test on scan day);
  • fMRI contra-indications (e.g., non-removable metallic implants, claustrophobia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • Gibson LP, Gust CJ, Gillman AS, Bryan AD, Feldstein Ewing SW. Mechanisms of Action for Empirically Supported Interventions to Reduce Adolescent Sexual Risk Behavior: A Randomized Controlled Trial. J Adolesc Health. 2020 Jul;67(1):53-60. doi: 10.1016/j.jadohealth.2020.01.004. Epub 2020 Mar 10.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sarah W Feldstein Ewing, Ph.D.

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2014

First Posted

May 19, 2014

Study Start

February 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 13, 2024

Record last verified: 2024-03

Locations