iKinnect2.0 for Juvenile Justice Involved Youth at Risk for Suicide

NCT ID: NCT04909203

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-10-21

Brief Summary

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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

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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.

Conditions

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Child Behavior Disorders Suicide and Self-harm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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iKinnect2.0

Parent-Youth dyads assigned to the iKinnect2.0 condition will be given access to the iKinnect2.0 app that has been developed for this study. Parent and youth will be asked to download the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial. The app is designed to be used several times throughout each day.

Group Type EXPERIMENTAL

iKinnect2.0

Intervention Type DEVICE

iKinnect2.0 is a paired mobile phone app for use on both Android and iOS operating systems by youth with conduct disorders and their parents.

Attention-Control Placebo App & Supporting Materials

Parent-Youth dyads assigned to the control condition will be asked to download the free Life360 app to their phone during the baseline assessment process and will also be given access to an online suicide resources brochure. Participants will be asked to use the control-condition app and associated materials as often as they would like throughout the duration of the 16 week trial.

Group Type PLACEBO_COMPARATOR

Active Control App

Intervention Type DEVICE

Mobile phone app for use on both Android and iOS operating systems for GPS tracking of other persons.

Interventions

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iKinnect2.0

iKinnect2.0 is a paired mobile phone app for use on both Android and iOS operating systems by youth with conduct disorders and their parents.

Intervention Type DEVICE

Active Control App

Mobile phone app for use on both Android and iOS operating systems for GPS tracking of other persons.

Intervention Type DEVICE

Eligibility Criteria

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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


* 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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Maryland

OTHER

Sponsor Role collaborator

Evidence-Based Practice Institute, Seattle, WA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda Dimeff, PhD

Role: PRINCIPAL_INVESTIGATOR

Evidence-Based Practice Institute

Cindy Schaeffer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

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University of Maryland, Baltimore

Baltimore, Maryland, United States

Site Status

Evidence-Based Practice Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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R44MH126819

Identifier Type: NIH

Identifier Source: secondary_id

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R44MH126819

Identifier Type: NIH

Identifier Source: org_study_id

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