DepressionT2CNCT03982043
Text2Connect, Component 2 of iCHART (Integrated Care to Help At-Risk Teens)
A study testing Text2Connect in people with Depression and Suicidal Ideation, run by University of Pittsburgh at 4 sites in United States.
Trial summary
This study proposes to develop and examine a personalized, text-based intervention designed to improve engagement with mental health (MH) treatment. Read more about this study
- Who is it for?
- Ages 12 to 26 years
- Conditions the study is for
- Depression, Suicidal Ideation
- What is being tested?
- Text2Connect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 May 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
CCP Waterdam
McMurray, Pennsylvania, 15317
Children's Community Pediatrics (CCP-Natrona Heights) of Children's Hospital of Pittsburgh of UPMC
Natrona Heights, Pennsylvania, 15065
Children's Community Pediatrics (CCP-GIL) of Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15206
STAR-Center
Pittsburgh, Pennsylvania, 15213
About this study
This study proposes to develop and examine a personalized, text-based intervention designed to improve engagement with mental health (MH) treatment.
Read the 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.
- Conditions
- Depression, Suicidal Ideation
- Being tested
- Text2Connect
- Medical subject headings
- Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text2ConnectBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Text2Connect |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Week 12 follow up after Baseline
Secondary outcomes (8)
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.
Measured: At Baseline phone visit
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At exit interview either following week 4 study visit or week 12 study visit (depending on when youth attend 1st mental health care appointment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start28 May 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Tina R Goldstein, University of Pittsburgh
- Investigators
- Tina Goldstein, PhD, Principal investigator, University of PittsburghBrian Suffoletto, MD, Study director, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982043
- Sponsor's protocol ID
- STUDY18120039
- Other IDs
- P50MH115838-02
- Acronym
- T2C
- Status last verified
- May 2022
- First submitted
- 7 Jun 2019
- Last updated
- 3 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text2Connect, Component 2 of iCHART (Integrated Care to Help At-Risk Teens)
- ClinicalTrials.gov ID
- NCT03982043
- Acronym / sponsor ID
- T2C / STUDY18120039
- Conditions
- Depression, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)
- Study start
- 28 May 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Posted 17 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Text2Connect | Experimental | Behavioral: Text2ConnectParticipants 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. |
Who may qualify
- Ages
- 12 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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)
- Score of 8 or higher on PHQ-8 -or- Score of 1 or higher on #9 of PHQ-9 suicidality item
- 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
Key exclusion criteria (4 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text2ConnectText2Connect 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. | Behavioural | Text2Connect |
Primary outcome
Attendance to Treatment
Time frame: 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)
Attendance to Treatment
Time frame: 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)
8 secondary outcomes
Number of SMS Messages Answered by Participants
Time frame: At Baseline phone visit
Number of SMS Messages Answered by Participants
Time frame: Week 4 follow up after Baseline
Number of SMS Messages Answered by Participants
Time frame: Week 12 follow up after Baseline
Service Utilization-Baseline
Time frame: At Baseline phone visit
Service Utilization-Follow Up 4 Weeks
Time frame: Week 4 follow up after Baseline
Service Utilization-Follow up 12 Weeks
Time frame: Week 12 follow up after Baseline
Usability & Satisfaction
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)
Usability & Satisfaction
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina Goldstein, PhD principal investigator
University of Pittsburgh
Brian Suffoletto, MD study director
University of Pittsburgh Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text2Connect in people with Depression and Suicidal Ideation, run by University of Pittsburgh at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance to Treatment (time frame: Week 4 follow up after Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.