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

This study proposes to develop and examine a personalized, text-based intervention designed to improve engagement with mental health (MH) treatment.

Study Overview

• Status: Completed
• Conditions: Depression; Suicidal Ideation
• Intervention / Treatment: Behavioral: Text2Connect

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: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • McMurray, Pennsylvania, United States, 15317
      • CCP Waterdam
    • Natrona Heights, Pennsylvania, United States, 15065
      • Children's Community Pediatrics (CCP-Natrona Heights) of Children's Hospital of Pittsburgh of UPMC
    • Pittsburgh, Pennsylvania, United States, 15206
      • Children's Community Pediatrics (CCP-GIL) of Children's Hospital of Pittsburgh of UPMC
    • Pittsburgh, Pennsylvania, United States, 15213
      • STAR-Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 26 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Week 12 follow up after Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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	At exit interview either following week 4 study visit or week 12 study visit (depending on when youth attend 1st mental health care appointment)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Mental Health (NIMH); Kaiser Foundation Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 28, 2019
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (ACTUAL): June 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: STUDY18120039; P50MH115838-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No