Depression, Suicidal Ideation
Conditions
Brief summary
This study proposes to develop and examine a personalized, text-based intervention designed to improve engagement with mental health (MH) treatment.
Detailed description
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.
Interventions
BEHAVIORALText2Connect
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.
Sponsors
Kaiser Foundation Research Institute
National Institute of Mental Health (NIMH)
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Ultimately, this study design was an open trial after unsuccessful attempts to maintain initial recruitment sites in the study. This study initially attempted to use a stepped wedge design, which involves the sequential random rollout of an intervention over 2 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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 26 Years
Healthy volunteers
No
Inclusion criteria
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 * Positive PHQ score or provider determines youth has depressive symptoms based on clinical interaction and refers youth to the study (in cases when PHQ is not available and study staff will complete the PHQ during the screening) OR Provider can refer if they are unclear if symptoms are depressive and PHQ scoring will be used to determine youth's eligibility. OR Screening Wizard screening questionnaire (which includes the PHQ and depressive symptom questions) indicates depression OR provider indicates there is a concern that youth has mood or behavioral problem. * Referred to mental health care OR screening wizard questionnaire (which indicates if provider makes referral to mental health care) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attendance to Treatment | Week 4 follow up after Baseline | Attendance to the embedded mental health care appointments will be assessed via electronic health record (EHR), as the primary outcome of Text2Connect (T2C) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of SMS Messages Answered by Participants | At Baseline phone visit | 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. |
| Service Utilization-Baseline | At Baseline phone visit | 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. |
| Service Utilization-Follow Up 4 Weeks | Week 4 follow up after 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. |
| Service Utilization-Follow up 12 Weeks | Week 12 follow up after 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. |
| Usability & Satisfaction | At exit interview either following week 4 study visit or week 12 study visit (depending on when youth attend 1st mental health care appointment) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Text2Connect 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.
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. | 43 |
| Treatment As Usual (TAU) Participants in the TAU group received a referral for mental health services from their Primary Care Physician (PCP) and did not receive the personalized text messaging intervention. | 4 |
| Total | 47 |
Baseline characteristics
| Characteristic | Text2Connect | Treatment As Usual (TAU) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 28 Participants | 4 Participants | 32 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 0 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 4 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 33 Participants | 2 Participants | 35 Participants |
| Region of Enrollment United States | 43 participants | 4 participants | 47 participants |
| Sex/Gender, Customized Sex at Birth Female | 35 Participants | 3 Participants | 38 Participants |
| Sex/Gender, Customized Sex at Birth Male | 8 Participants | 1 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 4 |
| other Total, other adverse events | 0 / 43 | 0 / 4 |
| serious Total, serious adverse events | 0 / 43 | 0 / 4 |
Outcome results
Primary
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
Population: Number of participants who completed the 4-week follow-up questions regarding treatment attendance
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Text2Connect | Attendance to Treatment | Attended appointment with mental health specialist | 22 Participants |
| Text2Connect | Attendance to Treatment | Did not attend appointment with mental health specialist | 20 Participants |
| Treatment as Usual (TAU) | Attendance to Treatment | Attended appointment with mental health specialist | 0 Participants |
| Treatment as Usual (TAU) | Attendance to Treatment | Did not attend appointment with mental health specialist | 4 Participants |
Primary
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
Population: Number of participants who completed 12 week follow-up questions regarding treatment attendance
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Text2Connect | Attendance to Treatment | Attended appointment with mental health specialist | 8 Participants |
| Text2Connect | Attendance to Treatment | Did not attend appointment with mental health specialist | 12 Participants |
| Treatment as Usual (TAU) | Attendance to Treatment | Attended appointment with mental health specialist | 2 Participants |
| Treatment as Usual (TAU) | Attendance to Treatment | Did not attend appointment with mental health specialist | 2 Participants |
Secondary
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
Population: Number of T2C SMS messages sent to participants between time of screening and baseline assessment
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Text2Connect | Number of SMS Messages Answered by Participants | 621 SMS Sent |
Secondary
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
Population: Number of SMS messages sent to participants between baseline and 4 week follow-up assessment.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Text2Connect | Number of SMS Messages Answered by Participants | 661 SMS Sent |
Secondary
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
Population: Number of SMS messages sent to participants between the 4 week and 12 week follow-up assessment.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Text2Connect | Number of SMS Messages Answered by Participants | 328 SMS Sent |
Secondary
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
Population: All participants in both treatment and TAU arms completed CASA assessment at Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Text2Connect | Service Utilization-Baseline | Use ER services | 5 Participants |
| Text2Connect | Service Utilization-Baseline | Use inpatient services | 9 Participants |
| Text2Connect | Service Utilization-Baseline | Use legal services | 0 Participants |
| Text2Connect | Service Utilization-Baseline | Use school services | 30 Participants |
| Text2Connect | Service Utilization-Baseline | Use medications | 30 Participants |
| Text2Connect | Service Utilization-Baseline | Use outpatient services | 35 Participants |
| Treatment as Usual (TAU) | Service Utilization-Baseline | Use medications | 0 Participants |
| Treatment as Usual (TAU) | Service Utilization-Baseline | Use outpatient services | 1 Participants |
| Treatment as Usual (TAU) | Service Utilization-Baseline | Use school services | 2 Participants |
| Treatment as Usual (TAU) | Service Utilization-Baseline | Use ER services | 0 Participants |
| Treatment as Usual (TAU) | Service Utilization-Baseline | Use inpatient services | 0 Participants |
| Treatment as Usual (TAU) | Service Utilization-Baseline | Use legal services | 0 Participants |
Secondary
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
Population: 42/43 participants responded to CASA assessment from Text2onnect intervention arm at week 12 and all Treatment As Usual participants completed CASA assessment as week 12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Text2Connect | Service Utilization-Follow up 12 Weeks | Use outpatient services | 23 Participants |
| Text2Connect | Service Utilization-Follow up 12 Weeks | Use school services | 6 Participants |
| Text2Connect | Service Utilization-Follow up 12 Weeks | Use ER services | 0 Participants |
| Text2Connect | Service Utilization-Follow up 12 Weeks | Use inpatient services | 0 Participants |
| Text2Connect | Service Utilization-Follow up 12 Weeks | Use legal services | 0 Participants |
| Text2Connect | Service Utilization-Follow up 12 Weeks | Use medications | 26 Participants |
| Treatment as Usual (TAU) | Service Utilization-Follow up 12 Weeks | Use legal services | 0 Participants |
| Treatment as Usual (TAU) | Service Utilization-Follow up 12 Weeks | Use outpatient services | 0 Participants |
| Treatment as Usual (TAU) | Service Utilization-Follow up 12 Weeks | Use inpatient services | 0 Participants |
| Treatment as Usual (TAU) | Service Utilization-Follow up 12 Weeks | Use school services | 0 Participants |
| Treatment as Usual (TAU) | Service Utilization-Follow up 12 Weeks | Use medications | 1 Participants |
| Treatment as Usual (TAU) | Service Utilization-Follow up 12 Weeks | Use ER services | 0 Participants |
Secondary
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
Population: All participants in both arms completed CASA assessment at 4 week follow up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Text2Connect | Service Utilization-Follow Up 4 Weeks | Use outpatient services | 28 Participants |
| Text2Connect | Service Utilization-Follow Up 4 Weeks | Use school services | 7 Participants |
| Text2Connect | Service Utilization-Follow Up 4 Weeks | Use ER services | 0 Participants |
| Text2Connect | Service Utilization-Follow Up 4 Weeks | Use legal services | 0 Participants |
| Text2Connect | Service Utilization-Follow Up 4 Weeks | Use inpatient services | 0 Participants |
| Text2Connect | Service Utilization-Follow Up 4 Weeks | Use medications | 25 Participants |
| Treatment as Usual (TAU) | Service Utilization-Follow Up 4 Weeks | Use inpatient services | 0 Participants |
| Treatment as Usual (TAU) | Service Utilization-Follow Up 4 Weeks | Use outpatient services | 0 Participants |
| Treatment as Usual (TAU) | Service Utilization-Follow Up 4 Weeks | Use legal services | 0 Participants |
| Treatment as Usual (TAU) | Service Utilization-Follow Up 4 Weeks | Use school services | 1 Participants |
| Treatment as Usual (TAU) | Service Utilization-Follow Up 4 Weeks | Use medications | 0 Participants |
| Treatment as Usual (TAU) | Service Utilization-Follow Up 4 Weeks | Use ER services | 0 Participants |
Secondary
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)
Population: Of the 43 participants in the T2C intervention group, 40 participants completed the exit interview which included these usability and satisfaction questions.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Text2Connect | Usability & Satisfaction | No, definitely not | 2 Participants |
| Text2Connect | Usability & Satisfaction | No, I don't think so | 10 Participants |
| Text2Connect | Usability & Satisfaction | Yes, I think so | 21 Participants |
| Text2Connect | Usability & Satisfaction | Yes, definitely | 7 Participants |
Secondary
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)
Population: Of the 43 participants in the T2C intervention group, 40 participants participated in the exit interview to answer the PSSUQ.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Text2Connect | Usability & Satisfaction | Overall, I am satisfied with how easy it is to use Text2Connect (1 to 7) | 6.1 score on a scale | Standard Deviation 1.1 |
| Text2Connect | Usability & Satisfaction | The information provided with T2C was clear (1 to 7) | 6.3 score on a scale | Standard Deviation 0.9 |
| Text2Connect | Usability & Satisfaction | I liked interacting with the T2C program (1 to 7) | 5.1 score on a scale | Standard Deviation 1.5 |
| Text2Connect | Usability & Satisfaction | I need to learn a lot of things before I could get going with T2C (1 to 5) | 1.4 score on a scale | Standard Deviation 1 |
| Text2Connect | Usability & Satisfaction | How satisfied were you with the amount of help you received (1 to 4) | 3.1 score on a scale | Standard Deviation 0.5 |
| Text2Connect | Usability & Satisfaction | Have the services you received helped you to deal more effectively with your problems? (1 to 4) | 2.8 score on a scale | Standard Deviation 0.6 |