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| ID | Type | Description | Link |
|---|---|---|---|
| P50MH115838-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kaiser Foundation Research Institute | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text2Connect | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text2Connect | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | Week 12 follow up after Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Baseline phone visit |
| Number of SMS Messages Answered by Participants |
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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
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.
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| Name | Affiliation | Role |
|---|---|---|
| Tina Goldstein, PhD | University of Pittsburgh | Principal Investigator |
| Brian Suffoletto, MD | University of Pittsburgh Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCP Waterdam | McMurray | Pennsylvania | 15317 | United States | ||
| Children's Community Pediatrics (CCP-Natrona Heights) of Children's Hospital of Pittsburgh of UPMC |
All requests for study data will follow NIMH's data sharing and data use policies.
The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies, including those funded by the innovation contests. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case report forms, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. For descriptive/raw data, study investigators/study staff will upload to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis all analyzed data being uploaded prior to primary paper publication.
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These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication.
In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators.
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| ID | Title | Description |
|---|---|---|
| FG000 | Text2Connect | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Number of participants who completed the 4-week follow-up questions regarding treatment attendance | Posted | Count of Participants | Participants | Week 4 follow up after Baseline |
|
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)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Text2Connect | 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. |
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Limitations included recruiting mostly White females, measuring MH care initiation through adolescent self-report, and not capturing specific MH/substance use diagnoses in addition to depression. Therefore, findings may not be valid in males or racial/ethnic minorities and we were limited in the understanding of severity and breadth of MH care needs.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tina R. Goldstein, Ph.D. | University of Pittsburgh | 4122465604 | goldtr@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2021 | Dec 1, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 2, 2021 | Jan 24, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
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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.
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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. |
| 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. | 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. | 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. | 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. | 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. | 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 | At exit interview either following week 4 study visit or week 12 study visit (depending on when youth attend 1st mental health care appointment) |
| Natrona Heights |
| Pennsylvania |
| 15065 |
| United States |
| Children's Community Pediatrics (CCP-GIL) of Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15206 | United States |
| STAR-Center | Pittsburgh | Pennsylvania | 15213 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Treatment as Usual (TAU) | Participants in the treatment as usual (TAU) group received a referral for mental health services from their Primary Care Physician (PCP). Participants in this group did not receive the personalized text messaging intervention, Text2Connect. |
|
|
| 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) | Number of participants who completed 12 week follow-up questions regarding treatment attendance | Posted | Count of Participants | Participants | Week 12 follow up after Baseline |
|
|
|
| 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. | Number of T2C SMS messages sent to participants between time of screening and baseline assessment | Posted | Count of Units | SMS Sent | At Baseline phone visit | SMS Sent | 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. | Number of SMS messages sent to participants between baseline and 4 week follow-up assessment. | Posted | Count of Units | SMS Sent | Week 4 follow up after Baseline | SMS Sent | 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. | Number of SMS messages sent to participants between the 4 week and 12 week follow-up assessment. | Posted | Count of Units | SMS Sent | Week 12 follow up after Baseline | SMS Sent | 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. | All participants in both treatment and TAU arms completed CASA assessment at Baseline | Posted | Count of Participants | Participants | At Baseline phone visit |
|
|
|
| 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. | All participants in both arms completed CASA assessment at 4 week follow up. | Posted | Count of Participants | Participants | Week 4 follow up after Baseline |
|
|
|
| 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. | 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 | Posted | Count of Participants | Participants | Week 12 follow up after Baseline |
|
|
|
| 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. | Of the 43 participants in the T2C intervention group, 40 participants completed the exit interview which included these usability and satisfaction questions. | Posted | Count of Participants | Participants | At exit interview either following week 4 study visit or week 12 study visit (depending on when youth attend 1st mental health care appointment) |
|
|
|
| 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 | Of the 43 participants in the T2C intervention group, 40 participants participated in the exit interview to answer the PSSUQ. | Posted | Mean | Standard Deviation | score on a scale | At exit interview either following week 4 study visit or week 12 study visit (depending on when youth attend 1st mental health care appointment) |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
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| Use ER services |
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| Use legal services |
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| Use inpatient services |
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| Use medications |
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| Use ER services |
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| Use legal services |
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| Use inpatient services |
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| Use medications |
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| Use ER services |
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| Use inpatient services |
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| Use legal services |
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| Use medications |
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| Yes, definitely |
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| I need to learn a lot of things before I could get going with T2C (1 to 5) |
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| How satisfied were you with the amount of help you received (1 to 4) |
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| Have the services you received helped you to deal more effectively with your problems? (1 to 4) |
|