Text 2 Connect- Texting Intervention for Mental Health Treatment Utilization (T2C)

ETUDES Center- Text2Connect - Phase 2

Text2Connect (T2C) proposes to test a text-based intervention designed to improve engagement with mental health treatment.

Study Overview

• Status: Completed
• Conditions: Depression; Suicidal Ideation
• Intervention / Treatment: Behavioral: Text2Connect; Behavioral: Psychoeducational Videos (PE) Only

Detailed Description

To enhance outcomes for transition-age youth with mental health disorders during the vulnerable period that occurs during their first several months of college, the investigators propose an automated TM intervention, "Text to Connect" (T2C), that aims to increase mental health self-efficacy through psychoeducation, self-monitoring of symptoms and stressors, and cues to action for college-bound youth.

Assignment of Interventions:

The study will utilize block randomization whereby 2/3 of participants will be randomly assigned to receive T2C, and 1/3 to receive PE. Blocks will balance the groups on site (CCP versus STAR/CABS). A 2:1 randomization scheme will randomize 50 youth to either receive T2C (n=30) or a link to brief psychoeducational videos about mental health (PE; n=20). All participants will then complete a brief battery of self-report assessments online at baseline and again monthly through month 4. Youth randomized to receive PE will receive a text message with the link to the webpage with the psychoeducational videos. Youth randomized to receive T2C will be onboarded and initiate the TM intervention that sends automated prompts at minimum monthly through month 4.

Hypothesis:

Aim 1. To examine the feasibility of T2C for transition-age youth with psychiatric disorders (n=3 clinics, 50 adolescents). Youth randomized to receive T2C will:

Hypothesis 1a. engage with T2C at high rates (>70% response rate to SMS prompts).

Hypothesis 1b. report high levels of satisfaction (>70% satisfaction) and usability with T2C.

Aim 2. To examine the impact of T2C versus PE on mental health self-efficacy, symptoms and functioning, and treatment engagement. Over 4 months, youth who receive T2C, as compared with youth who receive PE, will report:

Hypothesis 2a (Primary). Greater mental health self-efficacy Hypothesis 2b (Secondary). Lower symptom severity and greater psychosocial functioning Hypothesis 2c (Secondary). Higher rates of follow-through with mental health services

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • McMurray, Pennsylvania, United States, 15317
      • Children's Community Pediatrics (CCP- Waterdam) of Children's Hospital of Pittsburgh UPMC
    • Pittsburgh, Pennsylvania, United States, 15213
      • Child and Adolescent Bipolar Spectrum Services (CABS) Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • STAR Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant engaged in treatment at CC Waterdam, STAR or CABS clinic
• Participants have a current psychiatric diagnosis documented in their electronic medical record and/or be in receipt of mental health services within 3 months per self-/ parent- or clinician- report
• At least 18 years of age
• Recently graduated high school
• Planning to attend college or higher education program within 6 weeks
• Own a text-capable phone
• Be willing and able to provide informed consent

Exclusion Criteria:

• Participants will be excluded if they have conditions that might impair their ability to effectively engage in Text2Connect
• Under the age of 18yo
• Non-English speakers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Text2Connect; Participants receiving Text2Connect (T2C) personalized messages will receive a monthly check-in text prompt. Based on their response, the participants then receive either general psychoeducational videos and prompts to continue to monitor mental health or are then prompted to endorse stressors and symptoms they are experiencing to prompt awareness of treatment targets in daily life.	Behavioral: Text2Connect; The T2C intervention aims to increase mental health self-efficacy though psychoeducation, self-monitoring of symptoms and stressors, and cues to action for college-bound youth.
Active Comparator: Psychoeducational Videos (PE) Only; Participants will receive a web link to a library of 4 PE videos. These brief 2-minute videos include general information about self-care during college.	Behavioral: Psychoeducational Videos (PE) Only; Participants in this group will receive psychoeducation through the PE video library.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement With Intervention: Text Message Check-ins	Participant's engagement with the T2C intervention will be assessed via their response rate to SMS prompts, as the primary outcome of Text2Connect Phase 2. "High" engagement with T2C will be rated as >70% response rate. All Intervention participants (n=34) received text-message check-ins with question: "How would you rate your emotional health this past week?" on a likert scale of: 1=excellent; 2=very good; 3=good;4=fair; 5=poor. Participants who did not respond to this message initially were sent a reminder with the same content each week of the intervention.	Over 3 months after baseline
Engagement With Intervention: Web-based Check Ins	Participant's engagement with the T2C intervention will be assessed via their response rate to prompts, as the primary outcome of Text2Connect Phase 2. "High" engagement with T2C will be rated as >70% response rate. Participants received 1 text "How would you rate our emotional health this last week" on a likert scale of: 1 (excellent), 2 Very good, 3 good 4 fair 5 poor. If respondents answered "fair" or "Poor" they were routed to a website with psychoeducational videos and additional questions called a "web-based check in." The questions inquired what type of stressors the participant experienced contributing to the "Fair" or "Poor" ratings, what types of symptoms the participants noticed as a result of the indicated stressor and if participants felt they could manage their stress.	Over 3 months after baseline
Engagement With Intervention: Drop Out Rate	Participant's engagement with the T2C intervention will be assessed via their response rate to prompts, as the primary outcome of Text2Connect Phase 2. "High" engagement with T2C will be rated as >70% response rate. Participants are considered "dropped out" if they requested to be removed from the T2C intervention and all texts to be stopped.	Over 3 months after baseline
Usability & Satisfaction-PSSUQ	Satisfaction with the technical components of interventions will be assessed through the certain questions from the Post System Satisfaction and Usability Questionnaire (PSSUQ), as the primary outcome of Text2Connect Phase 2. The PSSUQ utilize 16 items w/ response options ranging from 1-7 where 1=strongly disagree and 7=strongly agree. The PSSUQ has sub-scores derived from subsets of the questions which reflect system usefulness, information quality, and interface quality. Scores are added and range from 16-112, with higher score indicating less satisfaction. Questions 1 to 16 result in the Overall score; Questions 1 to 6 result in System Usefulness score; Questions 7 to 12 result in Information Quality score; Questions 13 to 16 result in Interface Quality.	3 month follow up timepoint
Usability & Satisfaction-CSQ	Satisfaction with the technical components of interventions will be assessed through the certain questions from the Client Satisfaction Questionnaire (CSQ8). 8 items are scored on a likert scale of 1 to 4. Item 1 (reverse scored): scale 1(excellent)-4 (poor); Item 2: 1(definitely not)-4(definitely); item 3(reverse scored): 1(none of needs met)-4(all needs met); item 4: 1(definitely not)-4(definitely); item 5: 1(quite dissatisfied)-4(very satisfied); item 6(reverse scored): 1(made things worse)-4(helped a great deal); item 7 (reverse scored): 1(quite dissatisfied)-4(very satisfied); item 8: 1(definitely not)-4(definitely). Higher scores=higher satisfaction (score sum range is 8-32).	3 month follow up timepoint
Mental Health Self-Efficacy	Mental health self-efficacy will be assessed via the Mental Health Self-Efficacy Scale (MHSES), as the primary outcome of Text2Connect Phase 2. The MHSES contains 6 items that are scored on a 10-point Likert Scale. Scores range from 6-60 with higher scores indicating greater confidence in participant's mental health self-efficacy.	1 month timepoint
Mental Health Self-Efficacy	Mental health self-efficacy will be assessed via the Mental Health Self-Efficacy Scale (MHSES), as the primary outcome of Text2Connect Phase 2. The MHSES contains 6 items that are scored on a 10-point Likert Scale. Scores range from 6-60 with higher scores indicating greater confidence in participant's mental health self-efficacy.	3 month timepoint
Mental Health Self-Efficacy	Mental health self-efficacy will be assessed via the Mental Health Self-Efficacy Scale (MHSES), as the primary outcome of Text2Connect Phase 2. The MHSES contains 6 items that are scored on a 10-point Likert Scale. Scores range from 6-60 with higher scores indicating greater confidence in participant's mental health self-efficacy.	2 month timepoint
General Self-Efficacy	Mental health self-efficacy will be assessed via the General Self-Efficacy Scale (GSE), as the primary outcome of Text2Connect Phase 2. The GSE contains 10 items scored on a 4-point Likert Scale, with scores ranging from 10-40. Higher scores indicate greater self-efficacy.	1 month Timepoint
General Self-Efficacy	Mental health self-efficacy will be assessed via the General Self-Efficacy Scale (GSE), as the primary outcome of Text2Connect Phase 2. The GSE contains 10 items scored on a 4-point Likert Scale, with scores ranging from 10-40. Higher scores indicate greater self-efficacy.	2 month Timepoint
General Self-Efficacy	Mental health self-efficacy will be assessed via the General Self-Efficacy Scale (GSE), as the primary outcome of Text2Connect Phase 2. The GSE contains 10 items scored on a 4-point Likert Scale, with scores ranging from 10-40. Higher scores indicate greater self-efficacy.	3 month Timepoint

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychosocial Functioning	Psychosocial functioning will be assessed via the College Adjustment Questionnaire (CAQ) The CAQ contains 14 questions & 3 subscales (Educational, Relational, & Psychological functioning) embedded within. Each subscale is scored on 1(very inaccurate)-5 (very accurate) likert scale. Educational Functioning items include: 1, 5, 7, 12, 13; Relational Functioning items include: 2, 4, 9, 10, 14; Psychological Functioning items include: 3, 6, 8, 11. Items 2 & 9 from Relational subscale, 13 from Educational subscale, & 8 & 11 from Psychological subscale are reversed scored on 5 (very inaccurate)-1(very accurate) likert scale. The Educational functioning subscale score can be summed range from 5-25; the Relational functioning subscale score can be summed range from 5-25; the Psychological subscale can be summed range from 4-20. Total scores across all 3 subscales can be summed & range from 14-70. Higher scores indicate better functioning on each scale and across the total measure.	1 month timepoint
Psychosocial Functioning	Psychosocial functioning will be assessed via the College Adjustment Questionnaire (CAQ) The CAQ contains 14 questions & 3 subscales (Educational, Relational, & Psychological functioning) embedded within. Each subscale is scored on 1(very inaccurate)-5 (very accurate) likert scale. Educational Functioning items include: 1, 5, 7, 12, 13; Relational Functioning items include: 2, 4, 9, 10, 14; Psychological Functioning items include: 3, 6, 8, 11. Items 2 & 9 from Relational subscale, 13 from Educational subscale, & 8 & 11 from Psychological subscale are reversed scored on 5 (very inaccurate)-1(very accurate) likert scale. The Educational functioning subscale score can be summed range from 5-25; the Relational functioning subscale score can be summed range from 5-25; the Psychological subscale can be summed range from 4-20. Total scores across all 3 subscales can be summed & range from 14-70. Higher scores indicate better functioning on each scale and across the total measure.	2 month timepoint
Psychosocial Functioning	Psychosocial functioning will be assessed via the College Adjustment Questionnaire (CAQ) The CAQ contains 14 questions & 3 subscales (Educational, Relational, & Psychological functioning) embedded within. Each subscale is scored on 1(very inaccurate)-5 (very accurate) likert scale. Educational Functioning items include: 1, 5, 7, 12, 13; Relational Functioning items include: 2, 4, 9, 10, 14; Psychological Functioning items include: 3, 6, 8, 11. Items 2 & 9 from Relational subscale, 13 from Educational subscale, & 8 & 11 from Psychological subscale are reversed scored on 5 (very inaccurate)-1(very accurate) likert scale. The Educational functioning subscale score can be summed range from 5-25; the Relational functioning subscale score can be summed range from 5-25; the Psychological subscale can be summed range from 4-20. Total scores across all 3 subscales can be summed & range from 14-70. Higher scores indicate better functioning on each scale and across the total measure.	3 month timepoint
Symptom Severity	Symptom severity will be assessed via the CCAPS Mental Health Symptoms. The CCAPS is a 62-item instrument with 8 subscales (depression, general anxiety, social anxiety, academic distress, eating concerns, family distress, hostility, substance abuse) related to psychological symptoms & distress in college students. Scores are on a 5 point likert scale for each subscale: 0 (not at all like me), 1,2,3,4 (Extremely like me). Lower scores indicate greater severity of symptoms. Some items are reverse-scored. To score, average the items scores for each subscale to create the subscale raw score.	1 month timepoint
Symptom Severity	Symptom severity will be assessed via the CCAPS Mental Health Symptoms. The CCAPS is a 62-item instrument with 8 subscales (depression, general anxiety, social anxiety, academic distress, eating concerns, family distress, hostility, substance abuse) related to psychological symptoms & distress in college students. Scores are on a 5 point likert scale for each subscale: 0 (not at all like me), 1,2,3,4 (Extremely like me). Lower scores indicate greater severity of symptoms. Some items are reverse-scored. To score, average the items scores for each subscale to create the subscale raw score.	2 month timepoint
Symptom Severity	Symptom severity will be assessed via the CCAPS Mental Health Symptoms. The CCAPS is a 62-item instrument with 8 subscales (depression, general anxiety, social anxiety, academic distress, eating concerns, family distress, hostility, substance abuse) related to psychological symptoms & distress in college students. Scores are on a 5 point likert scale for each subscale: 0 (not at all like me), 1,2,3,4 (Extremely like me). Lower scores indicate greater severity of symptoms. Some items are reverse-scored. To score, average the items scores for each subscale to create the subscale raw score.	3 month timepoint
Mental Health Service Follow-through	Mental health service follow-through will be assessed via the Client Service Receipt Inventory (CSRI). Ratings of 4 questions are Yes or No indicating if participants received the type of service. Scores described below are count of participants indicating "Yes" on the scale.	1 month timepoint
Mental Health Service Follow-through	Mental health service follow-through will be assessed via the Client Service Receipt Inventory (CSRI). Ratings of 4 questions are Yes or No indicating if participants received the type of service. Scores described below are count of participants indicating "Yes" on the scale.	2 month timepoint
Mental Health Service Follow-through	Mental health service follow-through will be assessed via the Client Service Receipt Inventory (CSRI). Ratings of 4 questions are Yes or No indicating if participants received the type of service. Scores described below are count of participants indicating "Yes" on the scale.	3 month timepoint

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Mental Health (NIMH); Kaiser Foundation Research Institute
• Investigators: Principal Investigator: Tina Goldstein, PhD, University of Pittsburgh; Study Director: Brian Suffoletto, MD, University of Pittsburgh Medical Center

Publications and helpful links

General Publications

• Suffoletto B, Goldstein T, Gotkiewicz D, Gotkiewicz E, George B, Brent D. Acceptability, Engagement, and Effects of a Mobile Digital Intervention to Support Mental Health for Young Adults Transitioning to College: Pilot Randomized Controlled Trial. JMIR Form Res. 2021 Oct 14;5(10):e32271. doi: 10.2196/32271.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: treatment; depression; mental health; suicidal ideation; text message intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Depression; Suicidal Ideation
• Other Study ID Numbers: STUDY20060206; P50MH115838-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All requests for study data will follow NIMH's data sharing and data use policies. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies, including those funded by the innovation contests. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case report forms, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. For descriptive/raw data, study investigators/study staff will upload to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis all analyzed data being uploaded prior to primary paper publication.
• IPD Sharing Time Frame: These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication
• IPD Sharing Access Criteria: In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No