Taking Action for College Students

December 21, 2025 updated by: Temple University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes from Baseline in Mental Health Symptoms
Time Frame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up

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

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes from Baseline in Intention to Persist in College
Time Frame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up

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

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

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

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
Time Frame: Baseline, Immediately After the Intervention, 3 Month Follow-Up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Temple University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Disability, Independent Living, and Rehabilitation Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Taking Action

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings