Taking Action for College Students

A Randomized Controlled Trial of Taking Action Planning for College Students With Serious Mental Illnesses

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Bipolar Disorder; Major Depressive Disorder
• Intervention / Treatment: Behavioral: Taking Action

Detailed Description

The purpose of this study is to assess the feasibility, acceptability, and effectiveness associated with Taking Action for college students with serious mental illnesses (SMI). The study will be a randomized controlled trial. The investigators plan to recruit 300 college students with SMI to participate in the study. 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. The investigators will recruit from within Temple University and other colleges and universities in the United States.

Participants will be randomly assigned to one of two groups, 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 that will be delivered in a small group format online via videoconferencing.

All participants will complete 3 research interviews: baseline, post-intervention and follow-up, lasting about 1.5 hours each. Data related to the feasibility of research and intervention procedures, acceptability of the intervention, and clinical and academic outcomes will be collected and analyzed. The investigators will assess the feasibility of the intervention procedures by tracking data pertaining to recruitment, retention, and assessment using CONSORT guidelines, and data related to implementation of the intervention (i.e., fidelity, number of intervention meetings attended by participant). Fidelity to Taking Action will be assessed using a facilitator checklist based on prescribed content, procedures, and materials for each Taking Action session. Facilitators will also maintain attendance logs in RedCAP for each Taking Action session. The investigators will assess the acceptability of the intervention via quantitative and qualitative questions administered at post-intervention about participants' level of satisfaction and experiences with the intervention. The investigators will assess the clinical and academic outcomes of the intervention using the Mechanisms of Action Scale, Hopkins Symptom Checklist, Recovery Assessment Scale, College Persistence Questionnaire, Perceived Competence Scale, College Self-Efficacy Inventory, Study Habits Inventory, and Procrastination Assessment Scale - Students. Some exploratory measures will also be included in the interviews.

Feasibility and quantitative acceptability data will be reported using descriptive statistics. Qualitative acceptability data will be analyzed using thematic analysis. To examine the impact of Taking Action on mental health and academic outcomes random effect ANOVAs on repeated measures data in PROC MIXES (SAS) will be used to compare the experimental and control groups over time on the various measures. Prior to running the random effects ANOVAs above, the investigators will examine whether the experimental and control groups were different at baseline on any background characteristics despite randomization, and if so, control for them in the analyses. In addition, exploratory analyses will be conducted to provide insight regarding the characteristics of students who are most likely to benefit from Taking Action.

The investigators will recruit 300 individuals, which, with an estimated attrition rate of 25% based on previous experience with this population, will yield a sample of 225 participants with complete data. In a repeated measures ANOVA with two groups, three time points, and the correlation between repeated measures assumed to be 0.5, the investigators will be able to achieve .80 power to detect a small effect size of f=.085 in a time*group interaction term when the probability of a type I error, alpha, is set at .05. Even so, the investigators anticipate these power estimates are conservative, because of the use of PROC MIXED in SAS for analyzing repeated measures data. PROC MIXED does not discard participants with missing data at some time points, making the impact of missing data and attrition on power much less severe. GPower was used for power analysis.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Thomas, PhD; Phone Number: 2152041699; Email: elizabeth.thomas@temple.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19122
      • Recruiting
      • Temple University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 18 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Taking Action Intervention Condition; Participants in the experimental condition will participate in the Taking Action intervention.	Behavioral: Taking Action; 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.
No Intervention: Information Only Control Condition; 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from Baseline in Intention to Persist in College	The College Persistence Questionnaire is a validated instrument used to assess intention to persist in school. Scores range from -16 to +16 with higher scores indicating greater intention to persist in school. Change = (3-Month Follow-Up Score - Baseline Score).	Baseline, Immediately After the Intervention, and 3-Month Follow-Up
Changes from Baseline in Perceived Competence in Educational Environment	The Perceived Competence Scale is a validated instrument used to assess perceived competence that will be applied to an educational environment by asking how true items are "with respect to your learning in your school courses." Scores range from 1-7, with higher scores indicating greater perceived competence. Change = (3-Month Follow-Up Score - Baseline Score).	Baseline, Immediately After the Intervention, and 3-Month Follow-Up
Changes from Baseline in Study Habits	The Study Habits Inventory is a validated instrument used to assess study habits. Scores range from 1 to 7 with higher scores indicating better study habits. Change = (3-Month Follow-Up Score - Baseline Score).	Baseline, Immediately After the Intervention, and 3-Month Follow-Up
Changes from Baseline in Procrastination	The Procrastination Assessment Scale - Students is a validated measure used assess procrastination. Scores range from 1 to 5 with higher scores indicating greater procrastination. Change = (3-Month Follow-Up Score - Baseline Score).	Baseline, Immediately After the Intervention, and 3-Month Follow-Up
Change from Baseline in College Self-Efficacy	The College Self-Efficacy Inventory is a validated measure that assesses perceived self-efficacy in a college context. Scores range from 1 to 10 with higher scores indicating a better outcome. Change = (3-Month Follow-Up Score - Baseline Score).	Baseline, Immediately After the Intervention, 3 Month Follow-Up

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 22, 2024

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Recovery; Serious Mental Illness; College Students; Wellness; Taking Action
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Mood Disorders; Depressive Disorder; Schizophrenia; Bipolar Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 31680

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No