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Text 2 Connect- Texting Intervention for Mental Health Treatment Utilization

ETUDES Center- Text2Connect - Phase 2

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04560075
Acronym
T2C
Enrollment
52
Registered
2020-09-23
Start date
2020-10-01
Completion date
2021-01-31
Last updated
2023-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Suicidal Ideation

Keywords

depression, suicidal ideation, treatment, mental health, text message intervention

Brief summary

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

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

Interventions

BEHAVIORALText2Connect

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.

BEHAVIORALPsychoeducational Videos (PE) Only

Participants in this group will receive psychoeducation through the PE video library.

Sponsors

Kaiser Foundation Research Institute
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
General Self-Efficacy1 month TimepointMental 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.
Usability & Satisfaction-PSSUQ3 month follow up timepointSatisfaction 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.
Usability & Satisfaction-CSQ3 month follow up timepointSatisfaction 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).
Mental Health Self-Efficacy1 month timepointMental 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.
Engagement With Intervention: Text Message Check-insOver 3 months after baselineParticipant'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.
Engagement With Intervention: Web-based Check InsOver 3 months after baselineParticipant'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.
Engagement With Intervention: Drop Out RateOver 3 months after baselineParticipant'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.

Secondary

MeasureTime frameDescription
Symptom Severity1 month timepointSymptom 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.
Mental Health Service Follow-through1 month timepointMental 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.
Psychosocial Functioning1 month timepointPsychosocial 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
34
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.
18
Total52

Baseline characteristics

CharacteristicText2Connect InterventionTotalUsual Care-Psychoeducational Videos (PE) Only
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
34 Participants52 Participants18 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants3 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
32 Participants49 Participants17 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
General self-efficacy29.5 score on a scale
STANDARD_DEVIATION 3.9
28.8 score on a scale
STANDARD_DEVIATION 3.8
27.5 score on a scale
STANDARD_DEVIATION 3.3
Mental health self-efficacy40.3 score on a scale
STANDARD_DEVIATION 10.7
39.3 score on a scale
STANDARD_DEVIATION 11.1
37.4 score on a scale
STANDARD_DEVIATION 12
Mental health service follow-through
Any mental health
19 Participants31 Participants12 Participants
Mental health service follow-through
Inpatient
2 Participants4 Participants2 Participants
Mental health service follow-through
Outpatient
13 Participants22 Participants9 Participants
Mental health service follow-through
Primary Care
9 Participants13 Participants4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants3 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
33 Participants48 Participants15 Participants
Sex: Female, Male
Female
27 Participants45 Participants18 Participants
Sex: Female, Male
Male
7 Participants7 Participants0 Participants
Symptom Severity
Academic Distress
1.42 score on a scale
STANDARD_DEVIATION 1.02
1.58 score on a scale
STANDARD_DEVIATION 1
1.90 score on a scale
STANDARD_DEVIATION 0.88
Symptom Severity
Depression
1.43 score on a scale
STANDARD_DEVIATION 0.95
1.56 score on a scale
STANDARD_DEVIATION 0.97
1.81 score on a scale
STANDARD_DEVIATION 0.99
Symptom Severity
Eating Concerns
1.37 score on a scale
STANDARD_DEVIATION 0.89
1.42 score on a scale
STANDARD_DEVIATION 0.94
1.51 score on a scale
STANDARD_DEVIATION 1.06
Symptom Severity
Family Distress
1.28 score on a scale
STANDARD_DEVIATION 0.85
1.39 score on a scale
STANDARD_DEVIATION 0.84
1.58 score on a scale
STANDARD_DEVIATION 0.81
Symptom Severity
General Anxiety
1.80 score on a scale
STANDARD_DEVIATION 0.98
1.94 score on a scale
STANDARD_DEVIATION 0.98
2.22 score on a scale
STANDARD_DEVIATION 0.95
Symptom Severity
Hostility
1.00 score on a scale
STANDARD_DEVIATION 0.83
1.13 score on a scale
STANDARD_DEVIATION 0.78
1.38 score on a scale
STANDARD_DEVIATION 0.61
Symptom Severity
Social Anxiety
2.11 score on a scale
STANDARD_DEVIATION 0.93
2.20 score on a scale
STANDARD_DEVIATION 0.93
2.37 score on a scale
STANDARD_DEVIATION 0.93
Symptom Severity
Substance Abuse
0.33 score on a scale
STANDARD_DEVIATION 0.6
0.33 score on a scale
STANDARD_DEVIATION 0.64
0.33 score on a scale
STANDARD_DEVIATION 0.72

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 340 / 18
other
Total, other adverse events
0 / 340 / 18
serious
Total, serious adverse events
0 / 340 / 18

Outcome results

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.

Time frame: Over 3 months after baseline

Population: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Text2Connect InterventionEngagement With Intervention: Drop Out Rate0 Participants
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.

Time frame: Over 3 months after baseline

Population: 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.

ArmMeasureValue (MEDIAN)
Text2Connect InterventionEngagement With Intervention: Text Message Check-ins5 # of text messages sent to participants
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.

Time frame: Over 3 months after baseline

Population: 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.

ArmMeasureValue (COUNT_OF_UNITS)
Text2Connect InterventionEngagement With Intervention: Web-based Check Ins43 total number of web-based check-ins
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.

Time frame: 2 month Timepoint

Population: 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

ArmMeasureValue (MEAN)Dispersion
Text2Connect InterventionGeneral Self-Efficacy30.0 score on a scaleStandard Deviation 4.2
Usual Care-Psychoeducational Videos (PE) OnlyGeneral Self-Efficacy27.6 score on a scaleStandard Deviation 4.7
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.

Time frame: 1 month Timepoint

Population: 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

ArmMeasureValue (MEAN)Dispersion
Text2Connect InterventionGeneral Self-Efficacy29.7 score on a scaleStandard Deviation 4.4
Usual Care-Psychoeducational Videos (PE) OnlyGeneral Self-Efficacy28.3 score on a scaleStandard Deviation 3.8
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.

Time frame: 3 month Timepoint

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Text2Connect InterventionGeneral Self-Efficacy31.3 score on a scaleStandard Deviation 5.2
Usual Care-Psychoeducational Videos (PE) OnlyGeneral Self-Efficacy27.2 score on a scaleStandard Deviation 4.1
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.

Time frame: 1 month timepoint

Population: 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

ArmMeasureValue (MEAN)Dispersion
Text2Connect InterventionMental Health Self-Efficacy42.6 score on a scaleStandard Deviation 11.2
Usual Care-Psychoeducational Videos (PE) OnlyMental Health Self-Efficacy37.9 score on a scaleStandard Deviation 11
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.

Time frame: 3 month timepoint

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Text2Connect InterventionMental Health Self-Efficacy44.0 score on a scaleStandard Deviation 11
Usual Care-Psychoeducational Videos (PE) OnlyMental Health Self-Efficacy39.5 score on a scaleStandard Deviation 12.4
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.

Time frame: 2 month timepoint

Population: 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

ArmMeasureValue (MEAN)Dispersion
Text2Connect InterventionMental Health Self-Efficacy42.9 score on a scaleStandard Deviation 11.3
Usual Care-Psychoeducational Videos (PE) OnlyMental Health Self-Efficacy39.9 score on a scaleStandard Deviation 10.7
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).

Time frame: 3 month follow up timepoint

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Text2Connect InterventionUsability & Satisfaction-CSQ27.4 score on a scaleStandard Deviation 4.1
Usual Care-Psychoeducational Videos (PE) OnlyUsability & Satisfaction-CSQ25.4 score on a scaleStandard Deviation 5.8
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.

Time frame: 3 month follow up timepoint

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Text2Connect InterventionUsability & Satisfaction-PSSUQOverall Score32.3 score on a scaleStandard Deviation 25.3
Text2Connect InterventionUsability & Satisfaction-PSSUQSystem usefulness11.4 score on a scaleStandard Deviation 9.9
Text2Connect InterventionUsability & Satisfaction-PSSUQQuality of information13.1 score on a scaleStandard Deviation 9
Text2Connect InterventionUsability & Satisfaction-PSSUQQuality of interface7.7 score on a scaleStandard Deviation 6.7
Usual Care-Psychoeducational Videos (PE) OnlyUsability & Satisfaction-PSSUQQuality of interface9.0 score on a scaleStandard Deviation 7.3
Usual Care-Psychoeducational Videos (PE) OnlyUsability & Satisfaction-PSSUQOverall Score35.4 score on a scaleStandard Deviation 25.2
Usual Care-Psychoeducational Videos (PE) OnlyUsability & Satisfaction-PSSUQQuality of information14.4 score on a scaleStandard Deviation 10.3
Usual Care-Psychoeducational Videos (PE) OnlyUsability & Satisfaction-PSSUQSystem usefulness12.0 score on a scaleStandard Deviation 8.4
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.

Time frame: 3 month timepoint

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Text2Connect InterventionMental Health Service Follow-throughAny mental health care15 Participants
Text2Connect InterventionMental Health Service Follow-throughInpatient0 Participants
Text2Connect InterventionMental Health Service Follow-throughOutpatient12 Participants
Text2Connect InterventionMental Health Service Follow-throughPrimary care5 Participants
Usual Care-Psychoeducational Videos (PE) OnlyMental Health Service Follow-throughPrimary care1 Participants
Usual Care-Psychoeducational Videos (PE) OnlyMental Health Service Follow-throughAny mental health care7 Participants
Usual Care-Psychoeducational Videos (PE) OnlyMental Health Service Follow-throughOutpatient7 Participants
Usual Care-Psychoeducational Videos (PE) OnlyMental Health Service Follow-throughInpatient0 Participants
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.

Time frame: 1 month timepoint

Population: 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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Text2Connect InterventionMental Health Service Follow-throughAny mental health care17 Participants
Text2Connect InterventionMental Health Service Follow-throughInpatient0 Participants
Text2Connect InterventionMental Health Service Follow-throughOutpatient15 Participants
Text2Connect InterventionMental Health Service Follow-throughPrimary care4 Participants
Usual Care-Psychoeducational Videos (PE) OnlyMental Health Service Follow-throughPrimary care1 Participants
Usual Care-Psychoeducational Videos (PE) OnlyMental Health Service Follow-throughAny mental health care11 Participants
Usual Care-Psychoeducational Videos (PE) OnlyMental Health Service Follow-throughOutpatient11 Participants
Usual Care-Psychoeducational Videos (PE) OnlyMental Health Service Follow-throughInpatient0 Participants
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.

Time frame: 2 month timepoint

Population: 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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Text2Connect InterventionMental Health Service Follow-throughAny mental health care16 Participants
Text2Connect InterventionMental Health Service Follow-throughInpatient0 Participants
Text2Connect InterventionMental Health Service Follow-throughOutpatient12 Participants
Text2Connect InterventionMental Health Service Follow-throughPrimary care6 Participants
Usual Care-Psychoeducational Videos (PE) OnlyMental Health Service Follow-throughPrimary care3 Participants
Usual Care-Psychoeducational Videos (PE) OnlyMental Health Service Follow-throughAny mental health care11 Participants
Usual Care-Psychoeducational Videos (PE) OnlyMental Health Service Follow-throughOutpatient10 Participants
Usual Care-Psychoeducational Videos (PE) OnlyMental Health Service Follow-throughInpatient1 Participants
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.

Time frame: 1 month timepoint

Population: 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

ArmMeasureGroupValue (MEAN)Dispersion
Text2Connect InterventionPsychosocial FunctioningEducational Functioning21.0 score on a scaleStandard Deviation 4.8
Text2Connect InterventionPsychosocial FunctioningPsychological Functioning14.3 score on a scaleStandard Deviation 4.1
Text2Connect InterventionPsychosocial FunctioningRelational Functioning17.7 score on a scaleStandard Deviation 5.3
Usual Care-Psychoeducational Videos (PE) OnlyPsychosocial FunctioningEducational Functioning19.4 score on a scaleStandard Deviation 4
Usual Care-Psychoeducational Videos (PE) OnlyPsychosocial FunctioningPsychological Functioning12.1 score on a scaleStandard Deviation 4
Usual Care-Psychoeducational Videos (PE) OnlyPsychosocial FunctioningRelational Functioning14.5 score on a scaleStandard Deviation 6.2
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.

Time frame: 2 month timepoint

Population: 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

ArmMeasureGroupValue (MEAN)Dispersion
Text2Connect InterventionPsychosocial FunctioningEducational Functioning20.2 score on a scaleStandard Deviation 4.6
Text2Connect InterventionPsychosocial FunctioningPsychological Functioning14.3 score on a scaleStandard Deviation 4.3
Text2Connect InterventionPsychosocial FunctioningRelational Functioning17.3 score on a scaleStandard Deviation 5.2
Usual Care-Psychoeducational Videos (PE) OnlyPsychosocial FunctioningEducational Functioning17.7 score on a scaleStandard Deviation 5.6
Usual Care-Psychoeducational Videos (PE) OnlyPsychosocial FunctioningPsychological Functioning10.8 score on a scaleStandard Deviation 3.9
Usual Care-Psychoeducational Videos (PE) OnlyPsychosocial FunctioningRelational Functioning13.7 score on a scaleStandard Deviation 5.6
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.

Time frame: 3 month timepoint

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Text2Connect InterventionPsychosocial FunctioningEducational Functioning21.0 score on a scaleStandard Deviation 4.1
Text2Connect InterventionPsychosocial FunctioningPsychological Functioning14.2 score on a scaleStandard Deviation 3.8
Text2Connect InterventionPsychosocial FunctioningRelational Functioning17.1 score on a scaleStandard Deviation 5.1
Usual Care-Psychoeducational Videos (PE) OnlyPsychosocial FunctioningEducational Functioning18.0 score on a scaleStandard Deviation 6.5
Usual Care-Psychoeducational Videos (PE) OnlyPsychosocial FunctioningPsychological Functioning10.1 score on a scaleStandard Deviation 4.1
Usual Care-Psychoeducational Videos (PE) OnlyPsychosocial FunctioningRelational Functioning13.1 score on a scaleStandard Deviation 6.4
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.

Time frame: 1 month timepoint

Population: 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

ArmMeasureGroupValue (MEAN)Dispersion
Text2Connect InterventionSymptom SeverityDepression1.36 score on a scaleStandard Deviation 0.96
Text2Connect InterventionSymptom SeverityGeneral Anxiety1.82 score on a scaleStandard Deviation 1.05
Text2Connect InterventionSymptom SeveritySocial Anxiety2.06 score on a scaleStandard Deviation 1.07
Text2Connect InterventionSymptom SeverityAcademic Distress1.45 score on a scaleStandard Deviation 1.06
Text2Connect InterventionSymptom SeverityEating Concerns1.22 score on a scaleStandard Deviation 1.03
Text2Connect InterventionSymptom SeverityFamily Distress1.13 score on a scaleStandard Deviation 0.96
Text2Connect InterventionSymptom SeverityHostility0.93 score on a scaleStandard Deviation 0.8
Text2Connect InterventionSymptom SeveritySubstance Abuse0.43 score on a scaleStandard Deviation 0.72
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeveritySubstance Abuse0.32 score on a scaleStandard Deviation 0.54
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityDepression1.57 score on a scaleStandard Deviation 1
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityEating Concerns1.61 score on a scaleStandard Deviation 1.11
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityGeneral Anxiety2.02 score on a scaleStandard Deviation 1.07
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityHostility1.26 score on a scaleStandard Deviation 0.81
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeveritySocial Anxiety2.15 score on a scaleStandard Deviation 0.95
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityFamily Distress1.41 score on a scaleStandard Deviation 1
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityAcademic Distress1.76 score on a scaleStandard Deviation 0.96
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.

Time frame: 2 month timepoint

Population: 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

ArmMeasureGroupValue (MEAN)Dispersion
Text2Connect InterventionSymptom SeverityDepression1.24 score on a scaleStandard Deviation 0.94
Text2Connect InterventionSymptom SeverityGeneral Anxiety1.70 score on a scaleStandard Deviation 1.15
Text2Connect InterventionSymptom SeveritySocial Anxiety1.92 score on a scaleStandard Deviation 1.07
Text2Connect InterventionSymptom SeverityAcademic Distress1.39 score on a scaleStandard Deviation 1.06
Text2Connect InterventionSymptom SeverityEating Concerns1.21 score on a scaleStandard Deviation 0.97
Text2Connect InterventionSymptom SeverityFamily Distress1.18 score on a scaleStandard Deviation 0.82
Text2Connect InterventionSymptom SeverityHostility0.75 score on a scaleStandard Deviation 0.82
Text2Connect InterventionSymptom SeveritySubstance Abuse0.38 score on a scaleStandard Deviation 0.6
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeveritySubstance Abuse0.21 score on a scaleStandard Deviation 0.38
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityDepression1.85 score on a scaleStandard Deviation 1.02
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityEating Concerns1.72 score on a scaleStandard Deviation 1.13
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityGeneral Anxiety2.24 score on a scaleStandard Deviation 0.99
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityHostility1.39 score on a scaleStandard Deviation 0.86
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeveritySocial Anxiety2.39 score on a scaleStandard Deviation 1.02
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityFamily Distress1.13 score on a scaleStandard Deviation 0.83
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityAcademic Distress2.13 score on a scaleStandard Deviation 0.9
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.

Time frame: 3 month timepoint

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Text2Connect InterventionSymptom SeverityDepression1.12 score on a scaleStandard Deviation 0.94
Text2Connect InterventionSymptom SeverityGeneral Anxiety1.42 score on a scaleStandard Deviation 0.99
Text2Connect InterventionSymptom SeveritySocial Anxiety1.81 score on a scaleStandard Deviation 1.03
Text2Connect InterventionSymptom SeverityAcademic Distress1.31 score on a scaleStandard Deviation 0.98
Text2Connect InterventionSymptom SeverityEating Concerns1.01 score on a scaleStandard Deviation 0.86
Text2Connect InterventionSymptom SeverityFamily Distress0.93 score on a scaleStandard Deviation 0.63
Text2Connect InterventionSymptom SeverityHostility0.82 score on a scaleStandard Deviation 0.89
Text2Connect InterventionSymptom SeveritySubstance Abuse0.40 score on a scaleStandard Deviation 0.58
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeveritySubstance Abuse0.39 score on a scaleStandard Deviation 0.76
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityDepression1.83 score on a scaleStandard Deviation 1.11
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityEating Concerns1.55 score on a scaleStandard Deviation 0.97
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityGeneral Anxiety1.96 score on a scaleStandard Deviation 0.93
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityHostility1.10 score on a scaleStandard Deviation 0.73
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeveritySocial Anxiety2.39 score on a scaleStandard Deviation 0.9
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityFamily Distress1.10 score on a scaleStandard Deviation 0.71
Usual Care-Psychoeducational Videos (PE) OnlySymptom SeverityAcademic Distress2.12 score on a scaleStandard Deviation 1.11

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026