Suicide and Self-harm Clinical Trial
Official title:
iKinnect2.0 for Juvenile Justice Involved Youth at Risk for Suicide
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.
Status | Not yet recruiting |
Enrollment | 240 |
Est. completion date | July 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Evidence-Based Practice Institute | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Evidence-Based Practice Institute, Seattle, WA | National Institute of Mental Health (NIMH), University of Maryland |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) | |
Primary | 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. | baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) | |
Primary | 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 | baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) | |
Primary | 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. | baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) | |
Primary | 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. | baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) | |
Primary | 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. | baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) | |
Primary | 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. | baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) | |
Primary | 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. | baseline (time1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) | |
Primary | 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. | 1-16 weeks (time 4) |
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