Taking Action for College Students

NCT06700902 | Recruiting DMC

• 1 other identifier: 31680
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research is to investigate whether a peer-delivered illness self-management program called Taking Action can help college students with serious mental illnesses. Participants will be randomly assigned to either the experimental condition (Taking Action) or the control condition (information only). Participants in the experimental condition will attend five 2.5-hour Taking Action sessions. Participants will complete three interviews (baseline, post-intervention, and follow-up) to assess how well the program works, is liked, and benefits students clinically and academically. The investigators seek to test the following hypotheses: Compared to controls, students who do the Taking Action program will report greater improvements in mental health self-management attitudes, skills, and behaviors and will report greater improvements in mental health symptoms and recovery, and better academic outcomes.

Conditions

Major Depressive Disorder; Bipolar Disorder; Schizophrenia

Keywords

Taking Action; Recovery; Wellness; Serious Mental Illness; College Students

Outcome Measures

Primary Outcomes (2)

• Changes from Baseline in Mental Health Symptoms

  The Brief Symptom Inventory is a validated instrument used to assess mental health symptoms. The mean T-score is 50, with higher scores indicating worse outcome. Change = (3-Month Follow-Up Score - Baseline Score).

  Baseline, Immediately After the Intervention, and 3-Month Follow-Up

• Changes from Baseline in Perceived Recovery

  The Recovery Assessment Scale is a validated instrument used to assess perceived recovery from mental illness. Scores range from 1 to 5 with higher scores indicating greater perceived recovery. Change = (3-Month Follow-Up Score - Baseline Score).

  Baseline, Immediately After the Intervention, and 3-Month Follow-Up

Secondary Outcomes (5)

• Changes from Baseline in Intention to Persist in College

  Baseline, Immediately After the Intervention, and 3-Month Follow-Up

• Changes from Baseline in Perceived Competence in Educational Environment

  Baseline, Immediately After the Intervention, and 3-Month Follow-Up

• Changes from Baseline in Study Habits

  Baseline, Immediately After the Intervention, and 3-Month Follow-Up

• Changes from Baseline in Procrastination

  Baseline, Immediately After the Intervention, and 3-Month Follow-Up

• Change from Baseline in College Self-Efficacy

  Baseline, Immediately After the Intervention, 3 Month Follow-Up

Study Arms (2)

Taking Action Intervention Condition

EXPERIMENTAL

Participants in the experimental condition will participate in the Taking Action intervention.

Behavioral: Taking Action

Information Only Control Condition

NO INTERVENTION

Participants in the information only control condition will not participate in any intervention but will be given access to a resource entitled, "A Practical Guide for People with Disabilities Who Want to Go to College".

Interventions

Taking Action BEHAVIORAL

Participants in the experimental condition will participate in the Taking Action intervention, which will be delivered in a small group format in 5 weekly 2.5 hour videoconferencing sessions. Taking Action will be implemented using materials available on SAMHSA's website (https://www.co.ozaukee.wi.us/DocumentCenter/View/8198/Taking-Action-A-MH-Recovery-Self-Help-Ed-Program?bidId=). The process will include an overview of key recovery and wellness concepts and the development of an individualized wellness toolbox, which is a list of skills and strategies that a person already uses or would like to use to maintain or regain wellness. Then, participants will make plans for monitoring and addressing distressing mental health symptoms. Instructional techniques will include lectures, discussions, personal examples from facilitators and participants own lives to illustrate key concepts related to self-management, individual and group exercises, and voluntary action plans between meetings.

Taking Action Intervention Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently enrolled in a 2- or 4-year postsecondary educational institution in the United States (and are able to present a valid student ID card)
• Experiencing a serious mental illness, as operationalized by either:
• A score of 13 or higher on the K-6 Screening Scale for serious mental illness
• Self-reported psychiatric diagnosis of schizophrenia-spectrum or major affective disorder and self-reported lifetime functional impairment due to experiencing mental health challenges
• years of age or older
• Have consistent access to a computer or smartphone and the Internet for communications
• No prior WRAP or Taking Action education

You may not qualify if:

• Expected to graduate or complete their program within 2 semesters
• Unable to provide informed consent

Sponsors & Collaborators

• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator
• Temple University: lead

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Schizophrenia

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Central Study Contacts

Elizabeth Thomas, PhD

CONTACT

2152041699; elizabeth.thomas@temple.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 60 students will be enrolled in the study per semester, 30 of whom will be randomized to Taking Action and 30 to the control condition. Enrollment will occur over a period of 5 semesters, with two Taking Action groups running concurrently each semester. Randomization will occur at the participant-level and will be facilitated by using an HIPAA-compliant, Internet-based randomization service (studyrandomizer.com). The research assistant, who will be blind to the random allocation sequence, will enter participants into the randomization service after completion of the baseline interview and notify them of the condition to which they are assigned.

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: November 22, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)