Text 2 Connect- Texting Intervention for Mental Health Treatment Utilization

Depression Clinical Trial

— T2C  

Official title:

ETUDES Center- Text2Connect - Phase 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04560075
• Other study ID #: STUDY20060206
• Secondary ID: P50MH115838-02
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: May 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Suicidal Ideation

Intervention

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.
• Psychoeducational Videos (PE) Only
Participants in this group will receive psychoeducation through the PE video library.

Locations

Country	Name	City	State
United States	Children's Community Pediatrics (CCP- Waterdam) of Children's Hospital of Pittsburgh UPMC	McMurray	Pennsylvania
United States	Child and Adolescent Bipolar Spectrum Services (CABS) Center	Pittsburgh	Pennsylvania
United States	STAR Center	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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