Clinical trial NCT03982043: Text2Connect, Component 2 of iCHART (Integrated Care to Help At-Risk Teens)
Official title: Text2Connect, Component 2 of iCHART (Integrated Care to Help At-Risk Teens)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Suicidal Ideation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Kaiser Foundation Research Institute
name: National Institute of Mental Health (NIMH)
First posted: 2019-06-11
Enrollment: 47
Sex: ALL
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Attendance to Treatment
timeFrame: Week 4 follow up after Baseline
measure: Attendance to Treatment
timeFrame: Week 12 follow up after Baseline
Secondary outcomes:
measure: Number of SMS Messages Answered by Participants
timeFrame: At Baseline phone visit
measure: Number of SMS Messages Answered by Participants
timeFrame: Week 4 follow up after Baseline
measure: Number of SMS Messages Answered by Participants
timeFrame: Week 12 follow up after Baseline
measure: Service Utilization-Baseline
timeFrame: At Baseline phone visit
measure: Service Utilization-Follow Up 4 Weeks
timeFrame: Week 4 follow up after Baseline
measure: Service Utilization-Follow up 12 Weeks
timeFrame: Week 12 follow up after Baseline
measure: Usability & Satisfaction
timeFrame: At exit interview either following week 4 study visit or week 12 study visit (depending on when youth attend 1st mental health care appointment)
measure: Usability & Satisfaction
timeFrame: At exit interview either following week 4 study visit or week 12 study visit (depending on when youth attend 1st mental health care appointment)
Other outcomes:
Locations:
city: McMurray
country: United States
facility: CCP Waterdam
state: Pennsylvania
city: Natrona Heights
country: United States
facility: Children's Community Pediatrics (CCP-Natrona Heights) of Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Community Pediatrics (CCP-GIL) of Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: STAR-Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Tina Goldstein, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Medical Center
name: Brian Suffoletto, MD
role: STUDY_DIRECTOR
References: