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

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ClinicalTrials.gov Identifier: NCT03982043
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
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 June 11, 2019
Actual Study Start Date  ICMJE May 28, 2019
Estimated Primary Completion Date September 28, 2019   (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 No Changes Posted
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 will utilize a stepped-wedge cluster randomized trial design. This stepped wedge design 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.

This study will pilot Text2Connect in two community pediatric 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: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
This study will use a stepped wedge design, which involves the sequential random rollout of an intervention over multiple time periods.
Masking: Single (Outcomes Assessor)
Masking Description:
Outcomes assessors will be masked to the intervention condition at follow-up assessment timepoints.
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.
  • Behavioral: Treatment As Usual (TAU)
    Participants in this group will receive usual care at their pediatric primary care practice following referral to a mental health treatment provider.
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
  • Active Comparator: Treatment As Usual
    Participants in this group (TAU) will be studied as they proceed through treatment at their primary care providers office, per usual protocols at each office. Participants who are referred to mental health treatment for depression and suicidal risk at their primary care office may or may not be provided with additional support to engage in a referral.
    Intervention: Behavioral: Treatment As Usual (TAU)
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 September 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adolescent participants will be ages 12-17.11
  • Parent/guardian willing to consent
  • English speaking
  • possess adequate literacy to engage in study assessments and interventions.
  • All participants included in this study will screen positive for depression on the (Patient health questionnaire-9 items) PHQ-9 by a total score of > 11 or will score positively for suicidal ideation with a score on the PHQ-9 item 9 of > 1.

Exclusion Criteria:

  • Participants will be excluded if they have conditions that might impair their ability to effectively engage in Text2Connect,
  • in a current manic episode
  • in a current psychotic episode,
  • presence of a life-threatening medical condition requiring immediate treatment,
  • those with evidence of mental retardation or pervasive developmental disorder as known to the pediatrician by medical history.
  • Participants must also have access to a phone capable of text messaging.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
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 June 2019

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