Testing an Intergenerational Model of Suicide Risk in Mother-child Dyads
2 other identifiers
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2024
CompletedFirst Submitted
Initial submission to the registry
May 23, 2024
CompletedFirst Posted
Study publicly available on registry
June 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
May 15, 2025
May 1, 2025
4 years
May 23, 2024
May 14, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Child Mental Health Outcomes
Baseline, All Follow-up time points (3, 6, 12, and 24 months)
Child Mental Health Outcomes
Baseline, All Follow-up time points (3, 6, 12, and 24 months)
Study Arms (2)
Dialectical Behavior Therapy Skills Group Training
EXPERIMENTALThe investigators will employ Dialectical Behavior Therapy Skills Training in order to experimentally manipulate maternal emotion dysregulation, our targeted mechanism.
Safety Planning Intervention
EXPERIMENTALSafety Planning Intervention (SPI) or SPI only for 6 months, such that all mothers with history of suicidal behavior + ER difficulties will receive SPI.
Interventions
The investigators will employ Dialectical Behavior Therapy Skills Training in order to experimentally manipulate maternal emotion dysregulation, the targeted mechanism.
Safety Planning Intervention (SPI) or SPI only for 6 months, such that all mothers with history of suicidal behavior + ER difficulties will receive SPI.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- University of Oregoncollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie D Step, PhD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 23, 2024
First Posted
June 17, 2024
Study Start
April 1, 2024
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2028
Last Updated
May 15, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 12 months after accomplishment of each primary aim or objective, or upon publication of the project's primary results.
The investigators will archive data with the NIMH Data Archive (NDA) in two locations: (1) National Database for Clinical Trials Related to Mental Illness (NDCT), and (2) the Research Domain Criteria Database (RDoC db). Dr. Stepp will set up an NDA Account with access to NUID tool, and complete and submit an NDA Data Sharing Agreement for the project. The final dataset will cover clinical course and outcome data collected during the proposed project period. All data will be de-identified prior to submission to the NDCT and RDoCdb, and the team will obtain informed consent from participants to share their de-identified data. The investigators will fully comply with all NIH and IRB guidelines for data transfer, as well as federal regulations, including HIPAA.