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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03982043
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : October 20, 2020
Sponsor:
Collaborators:
Kaiser Foundation Research Institute
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Tina R Goldstein, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 11, 2019
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE May 28, 2019
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Application Utilization [ Time Frame: At Baseline phone visit ]
    Use of the technical components of T2C will be monitored. Utilization will be measured by the number and proportion of adolescents and parents who have engaged with the application over time.
  • Application Utilization [ Time Frame: Week 4 follow up after Baseline ]
    Use of the technical components of T2C will be monitored. Utilization will be measured by the number and proportion of adolescents and parents who have engaged with the application over time.
  • Application Utilization [ Time Frame: Week 12 follow up after Baseline ]
    Use of the technical components of T2C will be monitored. Utilization will be measured by the number and proportion of adolescents and parents who have engaged with the application over time.
  • Cost Effectiveness [ Time Frame: At Baseline phone visit ]
    Information on the incremental cost effectiveness of T2C will be gathered from the electronic health record (EHR) and the Child and Adolescent Service Assessment (CASA). The CASA collects information about the type, frequency, and intensity of services used at baseline.
  • Cost Effectiveness [ Time Frame: Week 4 follow up after Baseline ]
    Information on the incremental cost effectiveness of T2C will be gathered from the electronic health record (EHR) and the Child and Adolescent Service Assessment (CASA). The CASA collects information about the type, frequency, and intensity of services recent used during all follow-up assessments.
  • Cost Effectiveness [ Time Frame: Week 12 follow up after Baseline ]
    Information on the incremental cost effectiveness of T2C will be gathered from the electronic health record (EHR) and the Child and Adolescent Service Assessment (CASA). The CASA collects information about the type, frequency, and intensity of services recent used during all follow-up assessments.
  • 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) ]
    Satisfaction to T2C will be assessed through questions developed by investigators to understand experience with the program.
  • 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) ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Text2Connect, Component 2 of iCHART (Integrated Care to Help At-Risk Teens)
Official Title  ICMJE Text2Connect, Component 2 of iCHART (Integrated Care to Help At-Risk Teens)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.

Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Depression
  • Suicidal Ideation
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Text2Connect
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 26 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brandie George-Milford, MA 412-246-5629 georgeba2@upmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03982043
Other Study ID Numbers  ICMJE STUDY18120039
P50MH115838-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.

Time Frame: These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication.
Access Criteria: In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators.
Responsible Party Tina R Goldstein, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE
  • Kaiser Foundation Research Institute
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Tina Goldstein, PhD University of Pittsburgh
Study Director: Brian Suffoletto, MD University of Pittsburgh Medical Center
PRS Account University of Pittsburgh
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP