Text 2 Connect- Texting Intervention for Mental Health Treatment Utilization (T2C)
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| ClinicalTrials.gov Identifier: NCT04560075 |
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Recruitment Status :
Recruiting
First Posted : September 23, 2020
Last Update Posted : October 8, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Depression Suicidal Ideation | Behavioral: Text2Connect Behavioral: Psychoeducational Videos (PE) Only | Not Applicable |
To enhance outcomes for transition-age youth with mental health disorders during the vulnerable period that occurs during their first several months of college, the investigators propose an automated TM intervention, "Text to Connect" (T2C), that aims to increase mental health self-efficacy through psychoeducation, self-monitoring of symptoms and stressors, and cues to action for college-bound youth.
Assignment of Interventions:
The study will utilize block randomization whereby 2/3 of participants will be randomly assigned to receive T2C, and 1/3 to receive PE. Blocks will balance the groups on site (CCP versus STAR/CABS). A 2:1 randomization scheme will randomize 50 youth to either receive T2C (n=30) or a link to brief psychoeducational videos about mental health (PE; n=20). All participants will then complete a brief battery of self-report assessments online at baseline and again monthly through month 4. Youth randomized to receive PE will receive a text message with the link to the webpage with the psychoeducational videos. Youth randomized to receive T2C will be onboarded and initiate the TM intervention that sends automated prompts at minimum monthly through month 4.
Hypothesis:
Aim 1. To examine the feasibility of T2C for transition-age youth with psychiatric disorders (n=3 clinics, 50 adolescents). Youth randomized to receive T2C will:
Hypothesis 1a. engage with T2C at high rates (>70% response rate to SMS prompts).
Hypothesis 1b. report high levels of satisfaction (>70% satisfaction) and usability with T2C.
Aim 2. To examine the impact of T2C versus PE on mental health self-efficacy, symptoms and functioning, and treatment engagement. Over 4 months, youth who receive T2C, as compared with youth who receive PE, will report:
Hypothesis 2a (Primary). Greater mental health self-efficacy Hypothesis 2b (Secondary). Lower symptom severity and greater psychosocial functioning Hypothesis 2c (Secondary). Higher rates of follow-through with mental health services
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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. |
| Masking: | Single (Outcomes Assessor) |
| Masking Description: | Outcomes assessors will be masked to the intervention condition at follow-up assessment time points. |
| Primary Purpose: | Health Services Research |
| Official Title: | ETUDES Center- Text2Connect - Phase 2 |
| Actual Study Start Date : | October 1, 2020 |
| Estimated Primary Completion Date : | April 30, 2022 |
| Estimated Study Completion Date : | April 30, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Text2Connect
Participants receiving Text2Connect (T2C) personalized messages will receive a monthly check-in text prompt. Based on their response, the participants then receive either general psychoeducational videos and prompts to continue to monitor mental health or are then prompted to endorse stressors and symptoms they are experiencing to prompt awareness of treatment targets in daily life.
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Behavioral: Text2Connect
The T2C intervention aims to increase mental health self-efficacy though psychoeducation, self-monitoring of symptoms and stressors, and cues to action for college-bound youth. |
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Active Comparator: Psychoeducational Videos (PE) Only
Participants will receive a web link to a library of 4 PE videos. These brief 2-minute videos include general information about self-care during college.
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Behavioral: Psychoeducational Videos (PE) Only
Participants in this group will receive psychoeducation through the PE video library. |
- Engagement with intervention [ Time Frame: Up to 3 months after baseline ]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
- Usability & Satisfaction [ Time Frame: Up to 3 months after baseline ]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 is utilizing 16 out of 19 items with response options ranging from 1 to 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. Questions from sub-domains were chosen to tailor the questioning to this particular intervention. Scores range from 16-112, with higher score indicating less satisfaction.
- Usability & Satisfaction [ Time Frame: Up to 3 months after baseline ]Satisfaction with the technical components of interventions will be assessed through the certain questions from the Client Satisfaction Questionnaire (CSQ8), as the primary outcome of Text2Connect Phase 2. .
- Mental Health Self-Efficacy [ Time Frame: Up to 3 months after baseline ]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.
- Mental Health Self-Efficacy [ Time Frame: Up to 3 months after baseline ]Mental health self-efficacy will be assessed via the Self-Efficacy in Seeking Mental Health Care Scale (SE-SMHC), as the primary outcome of Text2Connect Phase 2. The SE-SMHC contains 9 items scored on a 10-point Likert Scale, with scores ranging from 9-81. Higher scores indicate greater confidence in participant's ability to seek mental health care.
- Mental Health Self-Efficacy [ Time Frame: Up to 3 months after baseline ]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.
- Psychosocial functioning [ Time Frame: Up to 3 months after baseline ]Psychosocial functioning will be assessed via the College Adjustment Questionnaire (CAQ), as the secondary outcome of Text2Connect Phase 2. The CAQ contains 14 questions in domains of academic adjustment, social adjustment, and emotional adjustment. 4 items are reversed scored, and scores range from 14-70. Higher scores indicate better psychosocial functioning.
- Symptom severity [ Time Frame: Up to 3 months after baseline ]Symptom severity will be assessed via the College Adjustment Questionnaire (CAQ), as the secondary outcome of Text2Connect Phase 2. The CAQ contains 14 questions in domains of academic adjustment, social adjustment, and emotional adjustment. 4 items are reversed scored, and scores range from 14-70. Lower scores indicate greater severity of symptoms.
- Mental health service follow-through [ Time Frame: Up to 3 months after baseline ]Mental health service follow-through will be assessed via the Client Service Receipt Inventory (CSRI), as the secondary outcome of Tex2Connect Phase 2.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560075
| Contact: Megan LaPorte, MS | 4129354985 | laportem@upmc.edu | |
| Contact: Brandie George-Milford, MA | 4122465629 | georgeba2@upmc.edu |
| United States, Pennsylvania | |
| Children's Community Pediatrics (CCP- Waterdam) of Children's Hospital of Pittsburgh UPMC | Recruiting |
| McMurray, Pennsylvania, United States, 15317 | |
| Contact: Dawn Gotkiewicz, MD 724-969-6970 gotkdx@upmc.edu | |
| Child and Adolescent Bipolar Spectrum Services (CABS) Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Tina Goldstein, PhD 412-246-5604 goldtr@upmc.edu | |
| STAR Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Kim Poling, LCSW 412-246-5617 polingKD@upmc.edu | |
| Principal Investigator: | Tina Goldstein, PhD | University of Pittsburgh | |
| Study Director: | Brian Suffoletto, MD | University of Pittsburgh Medical Center |
| Responsible Party: | Tina R Goldstein, Associate Professor of Psychiatry and Psychology, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT04560075 |
| Other Study ID Numbers: |
STUDY20060206 P50MH115838-02 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 23, 2020 Key Record Dates |
| Last Update Posted: | October 8, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | All requests for study data will follow NIMH's data sharing and data use policies. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies, including those funded by the innovation contests. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case report forms, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. For descriptive/raw data, study investigators/study staff will upload to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis all analyzed data being uploaded prior to primary paper publication. |
| Time Frame: | These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication |
| Access Criteria: | In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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depression suicidal ideation treatment mental health text message intervention |
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Depression Suicidal Ideation Behavioral Symptoms Suicide Self-Injurious Behavior |