Testing an Intergenerational Model of Suicide Risk in Mother-child Dyads
NCT Number: NCT06463054
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emotion Regulation
Interventions: BEHAVIORAL: Dialectical Behavior Therapy Skills Group Training|BEHAVIORAL: Safety Planning Intervention
Sponsor: University of Pittsburgh
Collaborators: University of Oregon|National Institute of Mental Health (NIMH)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-04-01
Completion Date: 2028-03-31
Locations: University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States

Summary:
The investigators are interested in learning more about how the role of mothers' emotions has on the transmission of suicide risk to children. Eligible participants will be invited to participate in a baseline assessment, and 4 follow-up assessments in the next year. This research study is a randomized control trial. Participants that choose to enroll are randomly assigned, that is by chance (like by flipping a coin) to receive DBT Skills Training or treatment as usual (TAU). Participants may also be selected for DBT skills training, it which would occur once a week for 6 months.

Primary Outcome Measures: Child Suicidal Thoughts and Behaviors, Suicidal thoughts and behaviors will be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).

C-SSRS will be scored with these domains, higher scores indicate worse outcomes Suicidal Ideation (Highest Level Endorsed 1-5) Intensity of Ideation (2-25) Suicidal Behavior (present during time period) Y/N Medical Damage for Attempt (0-5) Potential Lethality (if medical damage = 0) (0-2), Baseline, All Follow-up time points (3, 6, 12, and 24 months|Child Suicidal Thoughts and Behaviors, Suicidal thoughts and behaviors will be assessed the Intensity of Suicide Ideation Scale (SIS; PhenX Toolkit).

Intensity of Ideation Subscale The sum ranges from 2 to 25, with the higher number indicating more intense ideation., Baseline, All Follow-up time points (3, 6, 12, and 24 months
Secondary Outcome Measures: Child Mental Health Outcomes, Child mental health problems will assessed using the Youth Self-Report (YSR; child reports).

Youth Self-Report (YSR) The YSR is a 112-item self-report scale that measures problem behaviors using a 3-point Likert scale (0 = not true, 2 = somewhat or sometimes true, or 3=very true or often true). Raw scores are converted into standard scores. A standard score of 50 is average for a child's age and gender, with a standard deviation of 10 points. Higher scores indicate more problems. Each score is interpreted based on the T-Score and Percentile Score: Scores below the 95th percentile (approximate t-scores of 65 and below) are considered in the normal range, scores between the 95th and 98th percentile (approximate t-scores of 65-70) are considered to be in the borderline clinical range, and scores above the 98th percentile (approximate t-scores of 70 and greater) are considered to be in the clinical range., Baseline, All Follow-up time points (3, 6, 12, and 24 months)|Child Mental Health Outcomes, Child mental health problems will assessed using Child Behavior Checklist (CBCL; mother reports).

The Child Behavior Checklist (CBCL) consists of 113 items that measure problem behaviors, each rated on a 3-point Likert scale. Raw scores are converted into standard scores. A standard score of 50 is average for a child's age and gender, with a standard deviation of 10 points. Higher scores indicate more problems. Each score is interpreted based on the T-Score and Percentile Score: Scores below the 95th percentile (approximate t-scores of 65 and below) are considered in the normal range, scores between the 95th and 98th percentile (approximate t-scores of 65-70) are considered to be in the borderline clinical range, and scores above the 98th percentile (approximate t-scores of 70 and greater) are considered to be in the clinical range., Baseline, All Follow-up time points (3, 6, 12, and 24 months)