Trial Outcomes & Findings for Text2Connect, Component 2 of iCHART (Integrated Care to Help At-Risk Teens) (NCT NCT03982043)

NCT ID: NCT03982043

Last Updated: 2022-06-03

Results Overview

Attendance to the embedded mental health care appointments will be assessed via electronic health record (EHR), as the primary outcome of Text2Connect (T2C)

Recruitment status

COMPLETED

Study phase

Target enrollment

47 participants

Primary outcome timeframe

Week 4 follow up after Baseline

Results posted on

2022-06-03

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	43	4
Overall Study COMPLETED	43	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Text2Connect n=43 Participants 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.	Treatment As Usual (TAU) n=4 Participants 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 n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	28 Participants n=5 Participants	4 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	0 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Sex at Birth · Male	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Sex/Gender, Customized Sex at Birth · Female	35 Participants n=5 Participants	3 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants	4 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	2 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	4 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4 follow up after Baseline

Population: Number of participants who completed the 4-week follow-up questions regarding treatment attendance

Attendance to the embedded mental health care appointments will be assessed via electronic health record (EHR), as the primary outcome of Text2Connect (T2C)

Outcome measures

Outcome measures
Measure	Text2Connect n=42 Participants 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.	Treatment as Usual (TAU) n=4 Participants 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.
Attendance to Treatment Attended appointment with mental health specialist	22 Participants	0 Participants
Attendance to Treatment Did not attend appointment with mental health specialist	20 Participants	4 Participants

PRIMARY outcome

Timeframe: Week 12 follow up after Baseline

Population: Number of participants who completed 12 week follow-up questions regarding treatment attendance

Attendance to the embedded mental health care appointments will be assessed via electronic health record (EHR), as the primary outcome of Text2Connect (T2C)

Outcome measures

Outcome measures
Measure	Text2Connect n=20 Participants 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.	Treatment as Usual (TAU) n=4 Participants 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.
Attendance to Treatment Attended appointment with mental health specialist	8 Participants	2 Participants
Attendance to Treatment Did not attend appointment with mental health specialist	12 Participants	2 Participants

SECONDARY outcome

Timeframe: At Baseline phone visit

Population: Number of T2C SMS messages sent to participants between time of screening and baseline assessment

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.

Outcome measures

Outcome measures
Measure	Text2Connect n=698 SMS Sent 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.	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.
Number of SMS Messages Answered by Participants	621 SMS Sent	—

SECONDARY outcome

Timeframe: Week 4 follow up after Baseline

Population: Number of SMS messages sent to participants between baseline and 4 week follow-up assessment.

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.

Outcome measures

Outcome measures
Measure	Text2Connect n=744 SMS Sent 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.	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.
Number of SMS Messages Answered by Participants	661 SMS Sent	—

SECONDARY outcome

Timeframe: Week 12 follow up after Baseline

Population: Number of SMS messages sent to participants between the 4 week and 12 week follow-up assessment.

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.

Outcome measures

Outcome measures
Measure	Text2Connect n=366 SMS Sent 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.	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.
Number of SMS Messages Answered by Participants	328 SMS Sent	—

SECONDARY outcome

Timeframe: At Baseline phone visit

Population: All participants in both treatment and TAU arms completed CASA assessment at 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.

Outcome measures

Outcome measures
Measure	Text2Connect n=43 Participants 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.	Treatment as Usual (TAU) n=4 Participants 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.
Service Utilization-Baseline Use medications	30 Participants	0 Participants
Service Utilization-Baseline Use outpatient services	35 Participants	1 Participants
Service Utilization-Baseline Use school services	30 Participants	2 Participants
Service Utilization-Baseline Use ER services	5 Participants	0 Participants
Service Utilization-Baseline Use legal services	0 Participants	0 Participants
Service Utilization-Baseline Use inpatient services	9 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 4 follow up after Baseline

Population: All participants in both arms completed CASA assessment at 4 week follow up.

Outcome measures

Outcome measures
Measure	Text2Connect n=43 Participants 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.	Treatment as Usual (TAU) n=4 Participants 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.
Service Utilization-Follow Up 4 Weeks Use outpatient services	28 Participants	0 Participants
Service Utilization-Follow Up 4 Weeks Use school services	7 Participants	1 Participants
Service Utilization-Follow Up 4 Weeks Use ER services	0 Participants	0 Participants
Service Utilization-Follow Up 4 Weeks Use legal services	0 Participants	0 Participants
Service Utilization-Follow Up 4 Weeks Use inpatient services	0 Participants	0 Participants
Service Utilization-Follow Up 4 Weeks Use medications	25 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Text2Connect n=42 Participants 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.	Treatment as Usual (TAU) n=4 Participants 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.
Service Utilization-Follow up 12 Weeks Use outpatient services	23 Participants	0 Participants
Service Utilization-Follow up 12 Weeks Use school services	6 Participants	0 Participants
Service Utilization-Follow up 12 Weeks Use ER services	0 Participants	0 Participants
Service Utilization-Follow up 12 Weeks Use inpatient services	0 Participants	0 Participants
Service Utilization-Follow up 12 Weeks Use legal services	0 Participants	0 Participants
Service Utilization-Follow up 12 Weeks Use medications	26 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Text2Connect n=40 Participants 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.	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.
Usability & Satisfaction No, definitely not	2 Participants	—
Usability & Satisfaction No, I don't think so	10 Participants	—
Usability & Satisfaction Yes, I think so	21 Participants	—
Usability & Satisfaction Yes, definitely	7 Participants	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Text2Connect n=40 Participants 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.	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.
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	—
Usability & Satisfaction The information provided with T2C was clear (1 to 7)	6.3 score on a scale Standard Deviation 0.9	—
Usability & Satisfaction I liked interacting with the T2C program (1 to 7)	5.1 score on a scale Standard Deviation 1.5	—
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	—
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	—
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	—

Adverse Events

Text2Connect

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment As Usual (TAU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tina R. Goldstein, Ph.D.

University of Pittsburgh

Phone: 4122465604

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place