Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT06463054

Conditions

Emotion Regulation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Dialectical Behavior Therapy Skills Group Training

Safety Planning Intervention

Study Details

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.

Conditions

Emotion Regulation

Study ID

NCT06463054

Start date

Apr 1, 2024

Status verified date

Jun, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Dialectical Behavior Therapy Skills Group Training

The investigators will employ Dialectical Behavior Therapy Skills Training in order to experimentally manipulate maternal emotion dysregulation, our targeted mechanism.

experimental: Safety Planning Intervention

Safety Planning Intervention (SPI) or SPI only for 6 months, such that all mothers with history of suicidal behavior + ER difficulties will receive SPI.

Interventions

Dialectical Behavior Therapy Skills Group Training

The investigators will employ Dialectical Behavior Therapy Skills Training in order to experimentally manipulate maternal emotion dysregulation, the targeted mechanism.

Safety Planning Intervention

Safety Planning Intervention (SPI) or SPI only for 6 months, such that all mothers with history of suicidal behavior + ER difficulties will receive SPI.

Primary outcome measure

  • Child Suicidal Thoughts and Behaviors [ Time Frame: Baseline, All Follow-up time points (3, 6, 12, and 24 months ]
  • Child Suicidal Thoughts and Behaviors [ Time Frame: Baseline, All Follow-up time points (3, 6, 12, and 24 months ]

Central Contacts and Locations

Central contacts

Jennifer Wilson

412-952-7132bresjl@upmc.edu

Jennifer Stahler

4123833555stahlerj@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Principal Investigator:

Stephanie Stepp, PhD

More Information

Sponsor

University of Pittsburgh

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-06-04.