Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04909203
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2021-05-26
Brief Title:
iKinnect20 for Juvenile Justice Involved Youth at Risk for Suicide
Sponsor:
Evidence-Based Practice Institute Seattle WA
Organization:
Evidence-Based Practice Institute Seattle WA
Study Overview
Official Title:
iKinnect20 for Juvenile Justice Involved Youth at Risk for Suicide
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 iKinnect20 n60 dyads or Life360 control app plus an electronic suicide resources brochure n60 dyads This design will test iKinnect20s 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 youths 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 efficacyconfidence in parenting skills life stress TA youth functioning internalizing and externalizing symptoms parental management behaviors expectation clarity parental monitoring discipline effectivenessconsistency use of rewards and parent-youth relationship quality communication conflict support App satisfaction and use of technology outcomes ie 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 iKinnect20 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 N72 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 parentsguardians and key stakeholders probation officers parolere-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 iKinnect20 to an active control mobile app Investigators expect that iKinnect20 participants will report a significantly greater decrease in youths suicidal NSSI and conduct-problem behaviors and less recidivism Furthermore iKinnect20 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 iKinnect20 parents will report greater awareness of and confidence in applying evidence-based strategies to prevent suicideNSSI 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 delinquentcriminal 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
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 delinquentcriminal 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R44MH126819 | NIH | None | httpsreporternihgovquickSearchR44MH126819 |