Clinical trial NCT06700902: Taking Action for College Students
Official title: A Randomized Controlled Trial of Taking Action Planning for College Students with Serious Mental Illnesses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Bipolar Disorder
Schizophrenia
Keywords: Taking Action
Recovery
Wellness
Serious Mental Illness
College Students
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2024-11-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from Baseline in Mental Health Symptoms
timeFrame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
measure: Changes from Baseline in Perceived Recovery
timeFrame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
Secondary outcomes:
measure: Changes from Baseline in Intention to Persist in College
timeFrame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
measure: Changes from Baseline in Perceived Competence in Educational Environment
timeFrame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
measure: Changes from Baseline in Study Habits
timeFrame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
measure: Changes from Baseline in Procrastination
timeFrame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
measure: Change from Baseline in College Self-Efficacy
timeFrame: Baseline, Immediately After the Intervention, 3 Month Follow-Up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
References: