Child Behavior DisordersNCT04909203
iKinnect2.0 for Juvenile Justice Involved Youth at Risk for Suicide
A study testing iKinnect2.0 in people with Child Behavior Disorders and Suicide and Self-harm, run by Evidence-Based Practice Institute, Seattle, WA at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Child Behavior Disorders, Suicide and Self-harm
- What is being tested?
- iKinnect2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2023to 21 Oct 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Evidence-Based Practice Institute
Seattle, Washington, 98126
About this study
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.
Read the 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:
- iKinnect parents will report greater increases in parenting and suicide prevention efficacy.
- iKinnect youth will report greater decreases in suicidal, NSSI, and delinquent/criminal behaviors.
- iKinnect youth will report greater increases in coping with imminent distress and use of suicide prevention coping strategies.
- 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.
- iKinnect parents will report greater decreases in youth problem behaviors.
- Conditions
- Child Behavior Disorders, Suicide and Self-harm
- Being tested
- iKinnect2.0, Active Control App
- Keywords
- Criminal Justice, Juvenile Delinquency, Adolescent Suicidality, Self-Help Device, Assistive Technology
- Medical subject headings
- Child Behavior Disorders, Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iKinnect2.0Device
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.
Active Control AppDevice
Mobile phone app for use on both Android and iOS operating systems for GPS tracking of other persons.
| Study group | Role | What they receive |
|---|---|---|
| iKinnect2.0 | Experimental | 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. Receives: Device: iKinnect2.0 |
| Attention-Control Placebo App & Supporting Materials | Placebo comparator | 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. Receives: Device: Active Control App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Suicidal Ideation Questionnaire Junior (SIQ-JR)
Assesses youth frequency of suicidal ideation Scores range from 0 to 90, with a published clinical cut-off score of 31. Higher aggregated scores indicate negative outcomes.
Measured: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
Change in Service Assessment for Children and Adolescents
Interviewer-based structured measure to assess health care utilization with parallel parent and child versions. Parents report their children's mental health service-use history. Asks a maximum of 331 questions on service use by child (plus 10 introductory demographic questions). The initial 24 of the 331 are 'gate-level' questions which ask the parent about the child's lifetime use covering 23 different categories of service. A positive response on any lifetime service-use for a particular category leads to a separate section that askes more in-depth questions about service use in the past 12 months.
Measured: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
Change in Suicide Attempt Self-Injury Interview
Interviewer-administered instrument to assess the occurrence of youth suicidal and non-suicidal self-injuries (frequency, intent, medical severity, and outcomes). The final measure is assessed for reliability and validity with collateral measures. This interview based
Measured: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
Change in Center for Epidemiological Studies-Depression Scale (CES-D)
Assesses self-reported depressive symptoms experienced. Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology.
Measured: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
Change in The Coping Skills Use
Assesses frequency of skills use, perceived helpfulness of skills, and self-efficacy in using them. With 17 questions and responses ranging from 0 (strongly agree) to 4 (strongly disagree) there is a possible range of 0-68, with lower scores indicating better coping.
Measured: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
Change in Self-Report of Delinquency and Crime
Assesses frequency of youth engagement in particular delinquent or criminal behaviors. The 26-item widely-used measure asks youth to report how many times in the past two weeks they engaged in a number of delinquent and illegal behaviors. Total numbers of times are tallied for all items for the general delinquency scale (higher score indicates more delinquency). In addition, two subscales, status offenses and school delinquency may be examined.
Measured: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
Change in Achenbach (Child/Adult) Behavior Checklist
Assesses youth behavioral and emotional problems. Administered to parent only. Each subscale item relating to aggressive behavior (19 items; e.g., "gets in fights;" "attacks people") and rule breaking (17 items; e.g., "sets fires;" "steals outside of the home") had three possible responses (0=Not True; 1=Somewhat or sometimes true; 2=Very true or often true). With 113 questions and 3 spots for not covered behaviors a total possible range of 0 to 232; higher numbers indicate more problematic behaviors.
Measured: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
Change in Loeber Parenting Scale
Assesses parent and youth clarity of expectations, discipline consistency/effectiveness, and use of rewards. With 25 questions and each subscale having 3 possible responses - Never, Sometimes, and Always. Possible range of scores for the whole set includes high prevalence or infrequency of negative parenting skills in supervision, discipline consistency, discipline effectiveness, and positive parenting subscales; higher scores equal higher prevalence, lower scores equal infrequency.
Measured: baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4)
Change in app Satisfaction Survey
Assess ease of use and helpfulness of the assigned app. With a parent and child version and 10 questions with answers ranging from 0 (strongly disagree) to 5 (strongly agree) there is a possible range of 0-50 for the question set with higher numbers indicating better user experience/outcomes.
Measured: 1-16 weeks (time 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Jun 2023
- Primary completion21 Oct 2025
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavior DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evidence-Based Practice Institute, Seattle, WA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), University of Maryland
- Responsible party
- Sponsor
- Investigators
- Linda Dimeff, PhD, Principal investigator, Evidence-Based Practice InstituteCindy Schaeffer, PhD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909203
- Sponsor's protocol ID
- R44MH126819
- Other IDs
- R44MH126819
- Status last verified
- Dec 2025
- First submitted
- 26 May 2021
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Requests for use of data will be considered on a case-by-case basis. Interested researchers may send data requests to research@ebpi.org