T2C: Text2Connect, Component 2 of iCHART (Integrated Care to Help At-Risk Teens)

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT03982043
Collaborator
Kaiser Foundation Research Institute (Other), National Institute of Mental Health (NIMH) (NIH)
47
4
1
13.1
11.8
0.9

Study Details

Study Description

Brief Summary

This study proposes to develop and examine a personalized, text-based intervention designed to improve engagement with mental health (MH) treatment.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Text2Connect
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Text2Connect, Component 2 of iCHART (Integrated Care to Help At-Risk Teens)
Actual Study Start Date :
May 28, 2019
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. Attendance to Treatment [Week 12 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 Outcome Measures

  1. 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.

  2. Number of SMS Messages Answered by Participants [Week 4 follow up after Baseline]

    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.

  3. Number of SMS Messages Answered by Participants [Week 12 follow up after Baseline]

    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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 26 Years
Sexes Eligible for Study:
All
Accepts 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 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CCP Waterdam McMurray Pennsylvania United States 15317
2 Children's Community Pediatrics (CCP-Natrona Heights) of Children's Hospital of Pittsburgh of UPMC Natrona Heights Pennsylvania United States 15065
3 Children's Community Pediatrics (CCP-GIL) of Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15206
4 STAR-Center Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

  • University of Pittsburgh
  • Kaiser Foundation Research Institute
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Tina Goldstein, PhD, University of Pittsburgh
  • Study Director: Brian Suffoletto, MD, University of Pittsburgh Medical Center

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Tina R Goldstein, Associate Professor of Psychiatry and Psychology, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT03982043
Other Study ID Numbers:
  • STUDY18120039
  • P50MH115838-02
First Posted:
Jun 11, 2019
Last Update Posted:
Jun 3, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Text2Connect Treatment As Usual (TAU)
Arm/Group Description 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. 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.
Period Title: Overall Study
STARTED 43 4
COMPLETED 43 4
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Text2Connect Treatment As Usual (TAU) Total
Arm/Group Description 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. 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. Total of all reporting groups
Overall Participants 43 4 47
Age (Count of Participants)
<=18 years
28
65.1%
4
100%
32
68.1%
Between 18 and 65 years
15
34.9%
0
0%
15
31.9%
>=65 years
0
0%
0
0%
0
0%
Sex/Gender, Customized (Count of Participants)
Male
8
18.6%
1
25%
9
19.1%
Female
35
81.4%
3
75%
38
80.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
2
4.7%
0
0%
2
4.3%
Not Hispanic or Latino
41
95.3%
4
100%
45
95.7%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
2
4.7%
0
0%
2
4.3%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
3
7%
1
25%
4
8.5%
White
33
76.7%
2
50%
35
74.5%
More than one race
2
4.7%
1
25%
3
6.4%
Unknown or Not Reported
3
7%
0
0%
3
6.4%
Region of Enrollment (participants) [Number]
United States
43
100%
4
100%
47
100%

Outcome Measures

1. Primary Outcome
Title Attendance to Treatment
Description 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

Outcome Measure Data

Analysis Population Description
Number of participants who completed the 4-week follow-up questions regarding treatment attendance
Arm/Group Title Text2Connect Treatment as Usual (TAU)
Arm/Group Description 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. 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.
Measure Participants 42 4
Attended appointment with mental health specialist
22
51.2%
0
0%
Did not attend appointment with mental health specialist
20
46.5%
4
100%
2. Primary Outcome
Title Attendance to Treatment
Description 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

Outcome Measure Data

Analysis Population Description
Number of participants who completed 12 week follow-up questions regarding treatment attendance
Arm/Group Title Text2Connect Treatment As Usual (TAU)
Arm/Group Description 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. 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.
Measure Participants 20 4
Attended appointment with mental health specialist
8
18.6%
2
50%
Did not attend appointment with mental health specialist
12
27.9%
2
50%
3. Secondary Outcome
Title Number of SMS Messages Answered by Participants
Description 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

Outcome Measure Data

Analysis Population Description
Number of T2C SMS messages sent to participants between time of screening and baseline assessment
Arm/Group Title Text2Connect
Arm/Group Description 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.
Measure Participants 40
Measure SMS Sent 698
Count of Units [SMS Sent]
621
4. Secondary Outcome
Title Number of SMS Messages Answered by Participants
Description 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

Outcome Measure Data

Analysis Population Description
Number of SMS messages sent to participants between baseline and 4 week follow-up assessment.
Arm/Group Title Text2Connect
Arm/Group Description 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.
Measure Participants 24
Measure SMS Sent 744
Count of Units [SMS Sent]
661
5. Secondary Outcome
Title Number of SMS Messages Answered by Participants
Description 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

Outcome Measure Data

Analysis Population Description
Number of SMS messages sent to participants between the 4 week and 12 week follow-up assessment.
Arm/Group Title Text2Connect
Arm/Group Description 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.
Measure Participants 9
Measure SMS Sent 366
Count of Units [SMS Sent]
328
6. Secondary Outcome
Title Service Utilization-Baseline
Description 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

Outcome Measure Data

Analysis Population Description
All participants in both treatment and TAU arms completed CASA assessment at Baseline
Arm/Group Title Text2Connect Treatment as Usual (TAU)
Arm/Group Description 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. 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.
Measure Participants 43 4
Use outpatient services
35
81.4%
1
25%
Use school services
30
69.8%
2
50%
Use ER services
5
11.6%
0
0%
Use legal services
0
0%
0
0%
Use inpatient services
9
20.9%
0
0%
Use medications
30
69.8%
0
0%
7. Secondary Outcome
Title Service Utilization-Follow Up 4 Weeks
Description 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

Outcome Measure Data

Analysis Population Description
All participants in both arms completed CASA assessment at 4 week follow up.
Arm/Group Title Text2Connect Treatment as Usual (TAU)
Arm/Group Description 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. 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.
Measure Participants 43 4
Use outpatient services
28
65.1%
0
0%
Use school services
7
16.3%
1
25%
Use ER services
0
0%
0
0%
Use legal services
0
0%
0
0%
Use inpatient services
0
0%
0
0%
Use medications
25
58.1%
0
0%
8. Secondary Outcome
Title Service Utilization-Follow up 12 Weeks
Description 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

Outcome Measure Data

Analysis Population Description
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/Group Title Text2Connect Treatment as Usual (TAU)
Arm/Group Description 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. 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.
Measure Participants 42 4
Use outpatient services
23
53.5%
0
0%
Use school services
6
14%
0
0%
Use ER services
0
0%
0
0%
Use inpatient services
0
0%
0
0%
Use legal services
0
0%
0
0%
Use medications
26
60.5%
1
25%
9. Secondary Outcome
Title Usability & Satisfaction
Description 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)

Outcome Measure Data

Analysis Population Description
Of the 43 participants in the T2C intervention group, 40 participants completed the exit interview which included these usability and satisfaction questions.
Arm/Group Title Text2Connect
Arm/Group Description 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.
Measure Participants 40
No, definitely not
2
4.7%
No, I don't think so
10
23.3%
Yes, I think so
21
48.8%
Yes, definitely
7
16.3%
10. Secondary Outcome
Title Usability & Satisfaction
Description 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)

Outcome Measure Data

Analysis Population Description
Of the 43 participants in the T2C intervention group, 40 participants participated in the exit interview to answer the PSSUQ.
Arm/Group Title Text2Connect
Arm/Group Description 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.
Measure Participants 40
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)

Adverse Events

Time Frame 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)
Adverse Event Reporting Description
Arm/Group Title Text2Connect Treatment As Usual (TAU)
Arm/Group Description 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. 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.
All Cause Mortality
Text2Connect Treatment As Usual (TAU)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/43 (0%) 0/4 (0%)
Serious Adverse Events
Text2Connect Treatment As Usual (TAU)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/43 (0%) 0/4 (0%)
Other (Not Including Serious) Adverse Events
Text2Connect Treatment As Usual (TAU)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/43 (0%) 0/4 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Tina R. Goldstein, Ph.D.
Organization University of Pittsburgh
Phone 4122465604
Email goldtr@upmc.edu
Responsible Party:
Tina R Goldstein, Associate Professor of Psychiatry and Psychology, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT03982043
Other Study ID Numbers:
  • STUDY18120039
  • P50MH115838-02
First Posted:
Jun 11, 2019
Last Update Posted:
Jun 3, 2022
Last Verified:
May 1, 2022