NCT04691492

Brief Summary

The current project will provide testing of a friend-based motivational interview (FMI) designed to reduce sexual assault risk. The study will address if the intervention minimizes the impact of alcohol on helping behavior, test whether drinking reduces intervention efficacy, and examine potential iatrogenic effects of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

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

First Submitted

Initial submission to the registry

December 11, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2022

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

November 14, 2024

Completed
Last Updated

November 14, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

December 11, 2020

Results QC Date

June 5, 2024

Last Update Submit

October 23, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • Change in Readiness to Intervene on the Readiness Ruler

    Participants will use an 11-point likert-type scale modeled after the Readiness Ruler to rate their readiness for intervening. Responses range from 0 (I never think about my and/or my friend's risk of being sexually assaulted) to 10 (I am actively and consistently taking steps to protect myself and/or my friends from sexual assault), with higher scores indicating a greater readiness to intervene.

    Baseline and Monthly for 3 months

  • Change in Readiness to Intervene on the Decisional Balance Scale

    The 10-item Decisional Balance Scale (Banyard et al., 2007) is used to assess ambivalence about intervening in a potential assault situation. Responses regarding the decision whether to intervene or not are rated on a 5-point Likert scale ranging from 1 (Not at all likely) to 5 (Extremely likely), with higher scores indicating a greater readiness to intervene.

    Baseline and 3 month follow up

  • Change in Awareness and Strategies Regarding Alcohol Effects on Helping Survey

    This 8-item survey measures awareness of and strategies for alcohol's effects on helping behavior and participants' understanding of the ways that alcohol may interfere with helping behavior. Responses range from 1 (Not at all true) to 5 (Very much true), with higher scores indicating a greater understanding of how alcohol interferes with helping behavior.

    Baseline and Monthly for 3 months

  • Change in Friend-Based Helping Skills on Friend-based Assault Protective Strategies Assessment

    The Friend-based Assault Protective Strategies Assessment uses 20 items to assess sexual assault preventive strategy use. Responses range from 1 (Not at all) to 4 (A lot), with higher scores indicating a greater use of strategies to prevent sexual assault.

    Baseline and Monthly for 3 months

  • Change in Friend-Based Helping Skills on the Bystander Behaviors Scale for Friends

    We used a modified version of The Bystander Behaviors Scale for Friends is a 44-item measure which includes 4 sub-scales (1) the identification of sexual assault risk situations, (2) accessing resources, (3) planning ahead for risk situations, and (4) safety behaviors in risk settings. We used a selection of 20 questions from the full measure including items from each subscale. Response option include (0) No I did not engage in this behavior, (1) Yes I did engage in this behavior, or (missing) I did not perceive an opportunity to engage in this behavior. A higher endorsement of "Yes" (higher score) engaging in the behaviors is considered to indicate a greater use of strategies to prevent sexual assault.

    Baseline and Monthly for 3 months

  • Change in Perceived Barriers to Intervening on the Barriers to Sexual Assault Bystander Intervention Scale

    The Barriers to Sexual Assault Bystander Intervention Scale is a 16-item measure to assess barriers to intervening. Responses range from 1 (Strongly disagree) to 7 (Strongly agree), with higher scores indicating greater perceived barriers to intervening.

    Baseline and Monthly for 3 months

  • Change in Perceived Barriers to Intervening on the Concerns About Intervening Scale

    The Concerns About Intervening Scale uses 6 items to assess perceived barriers to intervening, focused on worries. Responses range from 1 (Not at all true) to 6 (Very much true), with higher scores indicating greater perceived barriers to intervening.

    Baseline and Monthly for 3 months

Secondary Outcomes (2)

  • Sexual Assault

    Monthly after baseline for 3 months

  • Change in Drinking

    Baseline and Monthly for 3 months

Study Arms (2)

Friends-Based Motivational Interview (FMI) Group

EXPERIMENTAL

Will participate in the Friends-Based Motivational Interview (FMI) program.

Behavioral: Friend-Based Motivational Interview

Wait List Control

NO INTERVENTION

The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).

Interventions

The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping.

Friends-Based Motivational Interview (FMI) Group

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female dyads who go out together at least once a week
  • Undergraduates enrolled in a 4-year college or university
  • Meet heavy episodic drinking (HED) criteria, 4 or more drinks in a single sitting, 2 or more times monthly

You may not qualify if:

  • Not Applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo Department of Psychology

Buffalo, New York, 14260, United States

Location

Related Publications (1)

  • Read JP, Livingston JA, Shaw RJ, Wiseblatt AF, Jenzer T, DiPaolo LR, Mastroleo NR, Katz J, Testa M, Colder CR. The power of friends in reducing sexual assault risk in college women: A preliminary test of dyad-based motivational intervention approach. J Consult Clin Psychol. 2024 Dec;92(12):814-827. doi: 10.1037/ccp0000925.

MeSH Terms

Conditions

Alcohol Drinking in College

Condition Hierarchy (Ancestors)

Alcohol DrinkingDrinking BehaviorBehavior

Results Point of Contact

Title
Jennifer Read, PhD.
Organization
University at Buffalo

Study Officials

  • Jennifer P Read, Ph.D.

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 31, 2020

Study Start

July 15, 2021

Primary Completion

September 16, 2022

Study Completion

September 16, 2022

Last Updated

November 14, 2024

Results First Posted

November 14, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

The investigators will share a de-identified data set which will include baseline demographics and readiness to intervene, awareness of alcohol's effects on helping behaviors, friend-based assault protective strategy use, and perception of barriers to intervening outcomes.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will become available in December 2021 and will be available until 2026.
Access Criteria
There must be an articulation of a clear research question and analytic plan by an established investigator with the relevant credentials. The information will be shared as a digital file through email.

Locations