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| ID | Type | Description | Link |
|---|---|---|---|
| P50MH115838-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kaiser Foundation Research Institute | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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Text2Connect (T2C) proposes to test a text-based intervention designed to improve engagement with mental health treatment.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text2Connect | Experimental | 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. |
|
| Psychoeducational Videos (PE) Only | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text2Connect | Behavioral | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tina Goldstein, PhD | University of Pittsburgh | Principal Investigator |
| Brian Suffoletto, MD | University of Pittsburgh Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Community Pediatrics (CCP- Waterdam) of Children's Hospital of Pittsburgh UPMC | McMurray | Pennsylvania | 15317 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34647893 | Derived | 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. |
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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.
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These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication
In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators.
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| ID | Title | Description |
|---|---|---|
| FG000 | Text2Connect Intervention | 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. 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. |
| FG001 | Usual Care-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. Psychoeducational Videos (PE) Only: Participants in this group will receive psychoeducation through the PE video library. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Text2Connect Intervention | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 2 participants lost to follow up at 1 month timepoint after baseline, 1 additional participant lost to follow up 3 month time point with final 31/34 participants completing research visits. | Posted | Median | Full Range | # of text messages sent to participants | Over 3 months after baseline |
|
Participant level information was assessed for adverse events at each of 3 follow up timepoints (1 month, 2 months, and 3 months after baseline).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Text2Connect Intervention | 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. 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. |
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Findings may not be valid in men or racial or ethnic minorities due to makeup of sample. This study may have a limited understanding of durability, prolonged engagement, and typical experiences and stresses related to college transition due to only following participants for 3 months during COVID pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tina Goldstein | University of Pittsburgh | (412) 246-5604 | goldtr@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2020 | Aug 26, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 21, 2020 | Aug 31, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D059020 | Suicidal Ideation |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
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| ID | Term |
|---|---|
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
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This study will use a parallel study design, where participants are randomized into two intervention groups (T2C and PE) and will receive interventions in parallel.
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Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.
| Psychoeducational Videos (PE) Only | Behavioral | Participants in this group will receive psychoeducation through the PE video library. |
|
| 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 |
| 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 |
| Child and Adolescent Bipolar Spectrum Services (CABS) Center |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| STAR Center | Pittsburgh | Pennsylvania | 15213 | United States |
| BG001 | Usual Care-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. Psychoeducational Videos (PE) Only: Participants in this group will receive psychoeducation through the PE video library. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| 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. | Count of Participants | Participants |
|
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. 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. |
|
|
| 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. | 2 participants lost to follow up at 1 month timepoint after baseline, 1 additional participant lost to follow up 3 month time point with final 31/34 participants completing research visits. 21/34 participants in this arm reported poor mental health on text-messages and therefore were provided with these web-based check ins. | Posted | Count of Units | total number of web-based check-ins | Over 3 months after baseline | total number of web-based check-ins | total number of web-based check-ins |
|
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| 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. | 2 participants lost to follow up at 1 month timepoint after baseline, 1 additional participant lost to follow up 3 month time point with final 31/34 participants completing research visits. 21/34 participants in this arm reported poor mental health on text-messages and therefore were provided with these web-based check ins. | Posted | Count of Participants | Participants | Over 3 months after baseline |
|
|
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline, 1 additional participant lost to follow up 3 month time point with final 31/34 participants completing research visits. In Usual Care Arm: 1 participant lost to follow up at 1 month time point, 2 additional participants lost to follow up at 2 month time point and 1 further participant lost at 3 month follow up timepoint. A total of 14/18 completed research visits in usual care arm. | Posted | Mean | Standard Deviation | score on a scale | 3 month follow up timepoint |
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| 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). | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline, 1 additional participant lost to follow up 3 month time point with final 31/34 participants completing research visits. In Usual Care Arm: 1 participant lost to follow up at 1 month time point, 2 additional participants lost to follow up at 2 month time point and 1 further participant lost at 3 month follow up timepoint. A total of 14/18 completed research visits in usual care arm. | Posted | Mean | Standard Deviation | score on a scale | 3 month follow up timepoint |
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline In Usual Care Arm: 1 participant lost to follow up at 1 month time point | Posted | Mean | Standard Deviation | score on a scale | 1 month timepoint |
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline, 1 additional participant lost to follow up 3 month time point with final 31/34 participants completing research visits. In Usual Care Arm: 1 participant lost to follow up at 1 month time point, 2 additional participants lost to follow up at 2 month time point and 1 further participant lost at 3 month follow up timepoint. A total of 14/18 completed research visits in usual care arm. | Posted | Mean | Standard Deviation | score on a scale | 3 month timepoint |
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline Usual Care: 2 additional participants lost to follow up at 2 month time point | Posted | Mean | Standard Deviation | score on a scale | 2 month timepoint |
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline In Usual Care Arm: 1 participant lost to follow up at 1 month time point | Posted | Mean | Standard Deviation | score on a scale | 1 month Timepoint |
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline In Usual Care Arm: 1 participant lost to follow up at 1 month time point, 2 additional participants lost to follow up at 2 month time point | Posted | Mean | Standard Deviation | score on a scale | 2 month Timepoint |
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline, 1 additional participant lost to follow up 3 month time point with final 31/34 participants completing research visits. In Usual Care Arm: 1 participant lost to follow up at 1 month time point, 2 additional participants lost to follow up at 2 month time point and 1 further participant lost at 3 month follow up timepoint. A total of 14/18 completed research visits in usual care arm. | Posted | Mean | Standard Deviation | score on a scale | 3 month Timepoint |
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline In Usual Care Arm: 1 participant lost to follow up at 1 month time point | Posted | Mean | Standard Deviation | score on a scale | 1 month timepoint |
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline In Usual Care Arm: 1 participant lost to follow up at 1 month time point, 2 additional participants lost to follow up at 2 month time point | Posted | Mean | Standard Deviation | score on a scale | 2 month timepoint |
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline, 1 additional participant lost to follow up 3 month time point with final 31/34 participants completing research visits. In Usual Care Arm: 1 participant lost to follow up at 1 month time point, 2 additional participants lost to follow up at 2 month time point and 1 further participant lost at 3 month follow up timepoint. A total of 14/18 completed research visits in usual care arm. | Posted | Mean | Standard Deviation | score on a scale | 3 month timepoint |
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline In Usual Care Arm: 1 participant lost to follow up at 1 month time point | Posted | Mean | Standard Deviation | score on a scale | 1 month timepoint |
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline In Usual Care Arm: 1 participant lost to follow up at 1 month time point, 2 additional participants lost to follow up at 2 month time point | Posted | Mean | Standard Deviation | score on a scale | 2 month timepoint |
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline, 1 additional participant lost to follow up 3 month time point with final 31/34 participants completing research visits. In Usual Care Arm: 1 participant lost to follow up at 1 month time point, 2 additional participants lost to follow up at 2 month time point and 1 further participant lost at 3 month follow up timepoint. A total of 14/18 completed research visits in usual care arm. | Posted | Mean | Standard Deviation | score on a scale | 3 month timepoint |
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline In Usual Care Arm: 1 participant lost to follow up at 1 month time point | Posted | Count of Participants | Participants | 1 month timepoint |
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline In Usual Care Arm: 1 participant lost to follow up at 1 month time point, 2 additional participants lost to follow up at 2 month time point | Posted | Count of Participants | Participants | 2 month timepoint |
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| 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. | In Intervention Arm: 2 participants lost to follow up at 1 month timepoint after baseline, 1 additional participant lost to follow up 3 month time point with final 31/34 participants completing research visits. In Usual Care Arm: 1 participant lost to follow up at 1 month time point, 2 additional participants lost to follow up at 2 month time point and 1 further participant lost at 3 month follow up timepoint. A total of 14/18 completed research visits in usual care arm. | Posted | Count of Participants | Participants | 3 month timepoint |
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| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Usual Care-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. Psychoeducational Videos (PE) Only: Participants in this group will receive psychoeducation through the PE video library. | 0 | 18 | 0 | 18 | 0 | 18 |
Not provided
Not provided
Not provided
| D010549 |
| Personal Satisfaction |
| D012959 |
| Socioeconomic Factors |
| Quality of information |
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| Quality of interface |
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| Relational Functioning |
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| Relational Functioning |
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| Relational Functioning |
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| Social Anxiety |
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| Academic Distress |
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| Eating Concerns |
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| Family Distress |
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| Hostility |
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| Substance Abuse |
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| Social Anxiety |
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| Academic Distress |
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| Eating Concerns |
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| Family Distress |
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| Hostility |
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| Substance Abuse |
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| Social Anxiety |
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| Academic Distress |
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| Eating Concerns |
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| Family Distress |
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| Hostility |
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| Substance Abuse |
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| Outpatient |
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| Primary care |
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| Outpatient |
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| Primary care |
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| Outpatient |
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| Primary care |
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