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

NCT03982043 | Completed Results DMC

• 2 other identifiers: STUDY18120039P50MH115838-02
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Depression; Suicidal Ideation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Number of SMS Messages Answered by Participants

  At Baseline phone visit

• Number of SMS Messages Answered by Participants

  Week 4 follow up after Baseline

• Number of SMS Messages Answered by Participants

  Week 12 follow up after Baseline

• Service Utilization-Baseline

  At Baseline phone visit

• Service Utilization-Follow Up 4 Weeks

  Week 4 follow up after Baseline

Study Arms (1)

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.

Behavioral: Text2Connect

Interventions

Text2Connect BEHAVIORAL

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.

Text2Connect

Eligibility Criteria

• Age: 12 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Kaiser Foundation Research Institute: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

CCP Waterdam

McMurray, Pennsylvania, 15317, United States

Location

Children's Community Pediatrics (CCP-Natrona Heights) of Children's Hospital of Pittsburgh of UPMC

Natrona Heights, Pennsylvania, 15065, United States

Location

Children's Community Pediatrics (CCP-GIL) of Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15206, United States

Location

STAR-Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depression; Suicidal Ideation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Limitations and Caveats

Limitations included recruiting mostly White females, measuring MH care initiation through adolescent self-report, and not capturing specific MH/substance use diagnoses in addition to depression. Therefore, findings may not be valid in males or racial/ethnic minorities and we were limited in the understanding of severity and breadth of MH care needs.

Results Point of Contact

• Title: Tina R. Goldstein, Ph.D.
• Organization: University of Pittsburgh

goldtr@upmc.edu

4122465604

Study Officials

• Tina Goldstein, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Brian Suffoletto, MD

  University of Pittsburgh Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Psychology

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 11, 2019
• Study Start: May 28, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: June 3, 2022
• Results First Posted: March 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (4)