Testing an Intergenerational Model of Suicide Risk in Mother-child Dyads
ConditionEmotion Regulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Biological mothers with legal custody of target child between 9-11
Confirmed lifetime Biological mothers with legal custody of target child between 9-11
Confirmed lifetime history of suicidal behavior for mothers of suicidal behavior for mothers
Disqualifiers
Any mothers and children with major medical illnesses that might be associated with organic personality changes or ER difficulties (e.g. Parkinson's Disease, seizure disorders)
Cardiac nervous system abnormalities that would influence physiological readings
Previous DBT (Dialectical Behavior Therapy) in the last six months
Trial design
Design model
Parallel
Treatments tested in this trial
Dialectical Behavior Therapy Skills Group Training
BehavioralThe investigators will employ Dialectical Behavior Therapy Skills Training in order to experimentally manipulate maternal emotion dysregulation, the targeted mechanism.
Safety Planning Intervention
BehavioralSafety Planning Intervention (SPI) or SPI only for 6 months, such that all mothers with history of suicidal behavior + ER difficulties will receive SPI.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Dialectical Behavior Therapy Skills Group TrainingExperimental treatment 1 intervention
Group B: Safety Planning InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Baseline, All Follow-up time points (3, 6, 12, and 24 months2
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.
Time frame
Baseline, All Follow-up time points (3, 6, 12, and 24 monthsSecondary outcomes
1
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.
Time frame
Baseline, All Follow-up time points (3, 6, 12, and 24 months)2
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.
Time frame
Baseline, All Follow-up time points (3, 6, 12, and 24 months)Sponsors and contacts
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University of Pittsburgh
Lead sponsor
University of Oregon
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov