An interventional study of Text2Connect in Depression and Suicidal Ideation, sponsored by University of Pittsburgh. Completed at 4 sites in United States. Open to participants aged 12 Years to 26 Years. Per ClinicalTrials.gov, last updated 2022-06-03.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research
This study proposes to develop and examine a personalized, text-based intervention designed to improve engagement with mental health (MH) treatment.
Text2Connect (T2C) aims to increase perceived susceptibility/severity of depression/suicidality and decrease stigma in at-risk adolescents and their parents. The investigators hypothesize that modification of patient beliefs leads to change talk, thereby increasing the experience of discrepancy which affects motivation for change. These experiences in turn influence decisional balance away from ambivalence toward readiness for change.
Assignment of Interventions:
This study utilized an open trial design. A stepped wedge design was originally proposed and efforts were made to adhere to this study design, however after a year of low recruitment and resultant recruitment sites pulling out the of the study, the overall study design was changed to an open trial. Additional recruitment sites were onboarded to the study and provided with the intervention arm in order to obtain feasibility data on the intervention components of the study. As a result of the change, there are some TAU participants included in this study.
For reference a stepped wedge design involves the sequential random rollout of an intervention over two time periods. Following a baseline period in which no clusters (=practices) are exposed to the intervention, the crossover is typically in one direction, from control to intervention and continues until both of the clusters have crossed-over to receive the intervention, with observations taken from each cluster and at each time period.
This study will pilot Text2Connect in community pediatric and mental health practices using a stepped wedge design (n = 50 adolescents).
Hypothesis: Readiness for mental health care will be greater among adolescents in T2C vs adolescents referred during TAU.
515 studies on the registry are indexed under Suicidal Ideation; 195 are open to participants now.
This study's enrollment of 47 is below the median of 80 across 426 interventional studies indexed under Suicidal Ideation.
Browse Suicidal Ideation studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Youth aged 12-26 yo Own a cell phone with text message capability Biological or adoptive parent is willing to provide informed consent for teen to participate Youth speaks and understands English
PHQ-9 scores:
Score of 8 or higher on PHQ-8 -or- Score of 1 or higher on #9 of PHQ-9 suicidality item
Parent inclusion criteria:
Age 18 or older Own a cell phone with text message capability Speaks and understands English Parent of a youth that scores positive on the PHQ-8 or #9 as described above Parent of a youth who has been referred to mental health treatment
Exclusion Criteria:
Non English speaking No parent willing to provide informed consent No cell phone with text messaging capability Is currently experiencing mania or psychosis Evidence of an intellectual or developmental disorder (IDD) Life threatening medical condition that requires immediate treatment Other cognitive or medical condition preventing youth from understanding study and/or participating.
Not referred to mental health care
Parent exclusion criteria:
No cell phone with text messaging capability Child meets exclusion criteria as described above Other cognitive or medical condition preventing parent from understanding study and/or participating.
Participants receiving Text2Connect (T2C) personalized messages aimed at increasing motivations in at-risk adolescents and their parents. The most salient of the following behavior change techniques will be selected and targeted messaging will be deployed on the participants' phone: psychoeducation, cued mood monitoring, adolescent-parent communication prompts, cognitive bias modification, and cues to action. Intervention material will be tailored to baseline characteristics and T2C will generate reports to providers.
Behavioral: Text2Connect
Text2Connect is a personalized text messaging intervention for patients and parents that targets self-identified barriers to engaging in treatment to increase the likelihood that a depressed or suicidal patient will initiate recommended services.
Attendance to Treatment
Attendance to the embedded mental health care appointments will be assessed via electronic health record (EHR), as the primary outcome of Text2Connect (T2C)
Time frame: Week 4 follow up after Baseline
Attendance to Treatment
Attendance to the embedded mental health care appointments will be assessed via electronic health record (EHR), as the primary outcome of Text2Connect (T2C)
Time frame: Week 12 follow up after Baseline
Number of SMS Messages Answered by Participants
Use of the technical components of T2C will be monitored. Utilization will be measured by the number of participant responses to the automatic T2C SMS messages at the baseline timepoint.
Time frame: At Baseline phone visit
Number of SMS Messages Answered by Participants
Use of the technical components of T2C will be monitored. Utilization will be measured by the number of participant responses to the automatic T2C SMS messages at the 4 week follow-up timepoint.
Time frame: Week 4 follow up after Baseline
Number of SMS Messages Answered by Participants
Use of the technical components of T2C will be monitored. Utilization will be measured by the number of participant responses to the automatic T2C SMS messages at the 12 week follow-up timepoint.
Time frame: Week 12 follow up after Baseline
Service Utilization-Baseline
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the Text2Connect intervention (including labor, equipment, supplies, facilitates) can be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
Time frame: At Baseline phone visit
Service Utilization-Follow Up 4 Weeks
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the Text2Connect intervention (including labor, equipment, supplies, facilitates) can be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
Time frame: Week 4 follow up after Baseline
Service Utilization-Follow up 12 Weeks
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the Text2Connect intervention (including labor, equipment, supplies, facilitates) can be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
Time frame: Week 12 follow up after Baseline
Usability & Satisfaction
Satisfaction to T2C will be assessed through questions developed by investigators to understand experience with the program. The question investigators have adapted from literature reviews on satisfaction is: "If a friend were in need of a mental health referral, would you recommend Text2Connect to him/her?" The response options include: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely.
Time frame: At exit interview either following week 4 study visit or week 12 study visit (depending on when youth attend 1st mental health care appointment)
Usability & Satisfaction
Satisfaction with the technical components of interventions will be assessed through the certain questions from the Post System Satisfaction and Usability Questionnaire (PSSUQ). The PSSUQ is 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. Another question about the need to learn new things before using the app was asked to be rated on a 1-5 scale, with 1= strongly disagree and 5= strongly agree. Two other satisfaction questions included were: "How satisfied are you with the amount of help you received?" The response options were on a scale of 1 (Very dissatisfied) to 4 (Very satisfied). "Have the services you received helped you to deal more effectively with your problems?" The response options were
Time frame: At exit interview either following week 4 study visit or week 12 study visit (depending on when youth attend 1st mental health care appointment)
| Milestone | Text2Connect | Treatment As Usual (TAU) |
|---|---|---|
| Started | 43 | 4 |
| Completed | 43 | 4 |
| Not completed | 0 | 0 |
Attendance to the embedded mental health care appointments will be assessed via electronic health record (EHR), as the primary outcome of Text2Connect (T2C)
| Participants | Text2Connect | Treatment as Usual (TAU) |
|---|---|---|
| Attended appointment with mental health specialist | 22 | 0 |
| Did not attend appointment with mental health specialist | 20 | 4 |
Attendance to the embedded mental health care appointments will be assessed via electronic health record (EHR), as the primary outcome of Text2Connect (T2C)
| Participants | Text2Connect | Treatment As Usual (TAU) |
|---|---|---|
| Attended appointment with mental health specialist | 8 | 2 |
| Did not attend appointment with mental health specialist | 12 | 2 |
Use of the technical components of T2C will be monitored. Utilization will be measured by the number of participant responses to the automatic T2C SMS messages at the baseline timepoint.
| SMS Sent | Text2Connect |
|---|---|
| Number of SMS Messages Answered by Participants | 621 |
Use of the technical components of T2C will be monitored. Utilization will be measured by the number of participant responses to the automatic T2C SMS messages at the 4 week follow-up timepoint.
| SMS Sent | Text2Connect |
|---|---|
| Number of SMS Messages Answered by Participants | 661 |
Use of the technical components of T2C will be monitored. Utilization will be measured by the number of participant responses to the automatic T2C SMS messages at the 12 week follow-up timepoint.
| SMS Sent | Text2Connect |
|---|---|
| Number of SMS Messages Answered by Participants | 328 |
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the Text2Connect intervention (including labor, equipment, supplies, facilitates) can be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
| Participants | Text2Connect | Treatment as Usual (TAU) |
|---|---|---|
| Use outpatient services | 35 | 1 |
| Use school services | 30 | 2 |
| Use ER services | 5 | 0 |
| Use legal services | 0 | 0 |
| Use inpatient services | 9 | 0 |
| Use medications | 30 | 0 |
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the Text2Connect intervention (including labor, equipment, supplies, facilitates) can be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
| Participants | Text2Connect | Treatment as Usual (TAU) |
|---|---|---|
| Use outpatient services | 28 | 0 |
| Use school services | 7 | 1 |
| Use ER services | 0 | 0 |
| Use legal services | 0 | 0 |
| Use inpatient services | 0 | 0 |
| Use medications | 25 | 0 |
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the Text2Connect intervention (including labor, equipment, supplies, facilitates) can be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
| Participants | Text2Connect | Treatment as Usual (TAU) |
|---|---|---|
| Use outpatient services | 23 | 0 |
| Use school services | 6 | 0 |
| Use ER services | 0 | 0 |
| Use inpatient services | 0 | 0 |
| Use legal services | 0 | 0 |
| Use medications | 26 | 1 |
Satisfaction to T2C will be assessed through questions developed by investigators to understand experience with the program. The question investigators have adapted from literature reviews on satisfaction is: "If a friend were in need of a mental health referral, would you recommend Text2Connect to him/her?" The response options include: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely.
| Participants | Text2Connect |
|---|---|
| No, definitely not | 2 |
| No, I don't think so | 10 |
| Yes, I think so | 21 |
| Yes, definitely | 7 |
Satisfaction with the technical components of interventions will be assessed through the certain questions from the Post System Satisfaction and Usability Questionnaire (PSSUQ). The PSSUQ is 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. Another question about the need to learn new things before using the app was asked to be rated on a 1-5 scale, with 1= strongly disagree and 5= strongly agree. Two other satisfaction questions included were: "How satisfied are you with the amount of help you received?" The response options were on a scale of 1 (Very dissatisfied) to 4 (Very satisfied). "Have the services you received helped you to deal more effectively with your problems?" The response options were
| score on a scale | Text2Connect |
|---|---|
| Overall, I am satisfied with how easy it is to use Text2Connect (1 to 7) | 6.1 ± 1.1 |
| The information provided with T2C was clear (1 to 7) | 6.3 ± 0.9 |
| I liked interacting with the T2C program (1 to 7) | 5.1 ± 1.5 |
| I need to learn a lot of things before I could get going with T2C (1 to 5) | 1.4 ± 1 |
| How satisfied were you with the amount of help you received (1 to 4) | 3.1 ± 0.5 |
| Have the services you received helped you to deal more effectively with your problems? (1 to 4) | 2.8 ± 0.6 |
Collected over Over the 1 year and 1 month of data collection for the study, participants were assessed for adverse events at each timepoint (baseline, 4 week follow-up, 12 week follow-up). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Text2Connect | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Treatment As Usual (TAU) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Text2Connect | Treatment As Usual (TAU) | Total |
|---|---|---|---|
| <=18 years | 28 | 4 | 32 |
| Between 18 and 65 years | 15 | 0 | 15 |
| >=65 years | 0 | 0 | 0 |
| Sex/Gender, Customized(Participants) | Text2Connect | Treatment As Usual (TAU) | Total |
|---|---|---|---|
| Sex at Birth — Male | 8 | 1 | 9 |
| Sex at Birth — Female | 35 | 3 | 38 |
| Ethnicity (NIH/OMB)(Participants) | Text2Connect | Treatment As Usual (TAU) | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 41 | 4 | 45 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Text2Connect | Treatment As Usual (TAU) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 33 | 2 | 35 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Region of Enrollment(participants) | Text2Connect | Treatment As Usual (TAU) | Total |
|---|---|---|---|
| United States | 43 | 4 | 47 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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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