Transition to College/Miami University
1 other identifier
interventional
60
1 country
1
Brief Summary
The current project will test whether a computerized training program, Cognitive Bias Modification (CBM), can be used as a prevention inoculation tool to reduce vulnerability to anxiety among incoming college students. Those not in the CBM condition will complete a symptom tracking condition (ST). We will also test whether ST influences vulnerability to anxiety among incoming college students.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2017
CompletedFirst Posted
Study publicly available on registry
September 12, 2017
CompletedStudy Start
First participant enrolled
September 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedDecember 19, 2017
December 1, 2017
1.3 years
August 30, 2017
December 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Student Adjustment to College Questionnaire
Self-report on the degree to which the participant feels they are transitioning to college successfully.
Participants report on their past few days. The SACQ is administered at T1-T5. T2 occurs within ~1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.
Secondary Outcomes (2)
Change in Interpretations
Participants report interpretations to a variety of situations. The IQ is administered at T1 and T4. T2 occurs within 1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.
Change in Liebowitz Social Anxiety Scale-Self-Report
Participants report on symptoms during the past week. The LSAS-SR is administered at T1-T5. T2 occurs within ~1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.
Study Arms (2)
Cognitive Bias Modification
EXPERIMENTALParticipants will complete three session of cognitive bias modification.
Symptom Tracking
OTHERParticipants will track their symptoms.
Interventions
CBM training. For those in the CBM condition, participants will complete a task. In this task, they will read ambiguous, two- to four-sentence social-related scenarios on the computer. The final word in the scenario will have a missing letter. Participants will type the missing letter. Participants will also be asked to answer a "Yes/No" comprehension question about the scenario. The missing letter will "resolve" the ambiguity of the scenario in a positive way, intended to train participants to have more positively-biased interpretations of ambiguous social information
Eligibility Criteria
You may qualify if:
- First and Second year students
- Entered college in fall of 2017
- Fluent in English
- LSAS-SR score greater than or equal to 14 and less than or equal to 74.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Miami Universitylead
Study Sites (1)
Anxiety Cognition and Emotion Laboratory
Oxford, Ohio, 45056, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Elise Clerkin, PhD
Miami University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 30, 2017
First Posted
September 12, 2017
Study Start
September 18, 2017
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
December 19, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share