Clinical trial NCT04909203: iKinnect2.0 for Juvenile Justice Involved Youth at Risk for Suicide
Official title: iKinnect2.0 for Juvenile Justice Involved Youth at Risk for Suicide
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Behavior Disorders
Suicide and Self-harm
Keywords: Criminal Justice
Juvenile Delinquency
Adolescent Suicidality
Self-Help Device
Assistive Technology
Lead sponsor: Evidence-Based Practice Institute, Seattle, WA
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Maryland
First posted: 2021-06-01
Enrollment: 240
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a 16-week intent-to-treat randomized controlled trial (RCT) with 120 suicidal juvenile justice (JJ)-involved transition-age (TA) youth (age 15-21 years) and a primary caregiver (dyads). Dyads will be randomly assigned to iKinnect2.0 (n=60 dyads) or Life360 (control app) plus an electronic suicide resources brochure (n=60 dyads). This design will test iKinnect2.0's new features for suicide prevention against TA youth awareness of and access to high-quality suicide prevention resources, while simultaneously testing features relating to conduct problems and parent management against parents knowing the TA youth's whereabouts in real-time and controlling for dyad member engagement in technology (Life360). Participants will be assessed at baseline, 4, 8 and 16 weeks. Primary youth-reported outcomes relating to suicide risk include: Suicidal behaviors (ideation, planning, attempts), non-suicidal self-injurious behaviors, self-efficacy in coping with distress, and use of imminent distress coping strategies (behavioral skills, use of crisis stabilization plan). Youth will also report on their criminal behavior. Primary caregiver-reported outcome variables relating to youth suicide include: Self-efficacy in applying family-based suicide-prevention strategies and reported use of those strategies; caregivers will also report on their own functioning (efficacy/confidence in parenting skills, life stress), TA youth functioning (internalizing and externalizing symptoms), parental management behaviors (expectation clarity, parental monitoring, discipline effectiveness/consistency, use of rewards), and parent-youth relationship quality (communication, conflict, support). App satisfaction and use of technology outcomes (i.e., degree of app usage, features used) will be examined and reported descriptively.

Detailed description: The goal of this 33-month Fast Track study is to significantly expand iKinnect, an efficacious paired mobile app that supports parents (in delivering) and youth (in receiving) evidence-based techniques to reduce youth problem behaviors such as delinquency and drug use. iKinnect2.0 will be expanded to also prevent non-suicidal self-injury (NSSI), suicidal behaviors, and death by suicide in juvenile justice (JJ) involved youth while continuing to prevent criminal recidivism. iKinnect was originally designed based on Multisystemic Therapy (MST) principles to help youth with serious conduct problems. Results from a randomized controlled trial (RCT; N=72) demonstrated its efficacy in reducing externalizing behaviors and improving parent effectiveness. This project seeks to significantly expand iKinnect to prevent NSSI, suicidal behaviors (ideation, planning, attempts), and death by suicide in JJ-involved transition age (TA) youth while continuing to decrease externalizing behaviors and prevent recidivism. Usability and acceptability testing will be conducted to test new features with target end-users (youth and their parents/guardians) and key stakeholders (probation officers, parole/re-entry officers, administrators, people with lived experience). Once usability and acceptability is achieved, an eight-week pilot will be conducted to test study procedures followed by a 16-week randomized controlled trial comparing iKinnect2.0 to an active control mobile app. Investigators expect that iKinnect2.0 participants will report a significantly greater decrease in youths' suicidal, NSSI, and conduct-problem behaviors, and less recidivism. Furthermore, iKinnect2.0 participants will report significantly greater use of behavioral skills and suicide prevention strategies (TA youth and parents), and greater self-efficacy in coping with emotional distress (TA youth). iKinnect2.0 parents will report greater awareness of and confidence in applying evidence-based strategies to prevent suicide/NSSI and to support their TA youth through a suicide crisis.

Investigators hypothesize that in comparison to the active control condition, iKinnect participants will show significantly better outcomes from baseline to the 4, 8, and 16-week assessment points such that:

1. iKinnect parents will report greater increases in parenting and suicide prevention efficacy.
2. iKinnect youth will report greater decreases in suicidal, NSSI, and delinquent/criminal behaviors.
3. iKinnect youth will report greater increases in coping with imminent distress and use of suicide prevention coping strategies.
4. iKinnect parents and youth will report greater increases in clarity of expectations, parental monitoring, discipline effectiveness, parent consistency, use of rewards, and positive parent-youth relations.
5. iKinnect parents will report greater decreases in youth problem behaviors.

Eligibility criteria: PARENT/GUARDIAN INCLUSION CRITERIA:

* 18 years or older
* Fluent in English
* Owns an Android or iPhone-based smartphone with a data plan and is the primary user of the phone
* Primary caregiver and supervisor of a youth aged 15-21 on probation or receiving post-incarceration reentry services at time of screening

YOUTH INCLUSION CRITERIA:

* Age 15-21 years
* Fluent in English
* Possesses and is the primary user of an Android or iPhone-based smartphone with a data plan
* Currently resides in same household as linked parent/legal guardian at least 5 days per week
* Has been arrested at least once and is receiving community-based JJ services related to probation or re-entry
* At significant risk for suicide, as evidenced by one of the following: one or more lifetime suicide attempts; elevated past-month suicidal ideation (\>24 on the SIQ-JR99, or self-injury repetition (\>3 lifetime self-harm episodes, including one in the past 12 weeks before screening)
* Willing to disclose NSSI and suicidal behaviors to parent

To ensure consistency of planned and actual enrollment, particularly of Black youth, researchers will begin to exclude youth of certain races once pre-established recruitment milestones for a specific racial group is achieved.

Primary outcomes:
measure: Change in Suicidal Ideation Questionnaire Junior (SIQ-JR)
timeFrame: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
measure: Change in Service Assessment for Children and Adolescents
timeFrame: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
measure: Change in Suicide Attempt Self-Injury Interview
timeFrame: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
measure: Change in Center for Epidemiological Studies-Depression Scale (CES-D)
timeFrame: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
measure: Change in The Coping Skills Use
timeFrame: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
measure: Change in Self-Report of Delinquency and Crime
timeFrame: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
measure: Change in Achenbach (Child/Adult) Behavior Checklist
timeFrame: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
measure: Change in Loeber Parenting Scale
timeFrame: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
measure: Change in app Satisfaction Survey
timeFrame: 1-16 weeks (time 4)
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Seattle
country: United States
facility: Evidence-Based Practice Institute
state: Washington
Study officials:
affiliation: Evidence-Based Practice Institute
name: Linda Dimeff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Cindy Schaeffer, PhD
role: PRINCIPAL_INVESTIGATOR
References: