Back to resultsText2Connect, Component 2 of iCHART (Integrated Care to Help At-Risk Teens) (T2C)
Primary Purpose
Depression, Suicidal Ideation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text2Connect
Sponsored by
About this trial
This is an interventional health services research trial for Depression
Eligibility Criteria
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.
Sites / Locations
- CCP Waterdam
- Children's Community Pediatrics (CCP-Natrona Heights) of Children's Hospital of Pittsburgh of UPMC
- Children's Community Pediatrics (CCP-GIL) of Children's Hospital of Pittsburgh of UPMC
- STAR-Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Text2Connect
Arm 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.
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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 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 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.
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.
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.
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.
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.
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
Full Information
NCT ID
NCT03982043
First Posted
June 7, 2019
Last Updated
May 6, 2022
Sponsor
University of Pittsburgh
Collaborators
Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03982043
Brief Title
Text2Connect, Component 2 of iCHART (Integrated Care to Help At-Risk Teens)
Acronym
T2C
Official Title
Text2Connect, Component 2 of iCHART (Integrated Care to Help At-Risk Teens)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Suicidal Ideation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Text2Connect
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Text2Connect
Intervention Description
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.
Primary Outcome Measure Information:
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
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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)
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina Goldstein, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian Suffoletto, MD
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
CCP Waterdam
City
McMurray
State/Province
Pennsylvania
ZIP/Postal Code
15317
Country
United States
Facility Name
Children's Community Pediatrics (CCP-Natrona Heights) of Children's Hospital of Pittsburgh of UPMC
City
Natrona Heights
State/Province
Pennsylvania
ZIP/Postal Code
15065
Country
United States
Facility Name
Children's Community Pediatrics (CCP-GIL) of Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
STAR-Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication.
IPD Sharing Access Criteria
In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators.
Learn more about this trial
Text2Connect, Component 2 of iCHART (Integrated Care to Help At-Risk Teens)
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