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Behavioral Intervention

DBT Skills Training + Safety Planning for Suicide Risk

N/A
Recruiting
Led By Stephanie D Step, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biological mothers with legal custody of target child between 9-11
Must not have
Cardiac nervous system abnormalities that would influence physiological readings
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, all follow-up time points (3, 6, 12, and 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to understand how a mother's emotions can impact the risk of suicide in her children. Participants will undergo assessments and follow-ups for a year. The study is a randomized controlled trial where participants

Who is the study for?
This trial is for biological mothers with legal custody of a child aged 9-11, who have a history of suicidal behavior. It's not suitable for those with cardiac or nervous system abnormalities, recent DBT therapy, or major medical illnesses like Parkinson's Disease that affect personality or emotion regulation.
What is being tested?
The study compares Dialectical Behavior Therapy (DBT) Skills Training against treatment as usual for reducing suicide risk. Mothers are randomly assigned to either attend weekly DBT sessions for six months or receive the standard care.
What are the potential side effects?
While specific side effects are not listed, DBT generally involves discussing and managing emotional distress which can sometimes be uncomfortable but is part of the therapeutic process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am the biological mother with legal custody of a child aged 9-11.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have heart or nervous system conditions that could affect heart rate or blood pressure measurements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, all follow-up time points (3, 6, 12, and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, all follow-up time points (3, 6, 12, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Child Suicidal Thoughts and Behaviors
Secondary study objectives
Child Mental Health Outcomes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Safety Planning InterventionExperimental Treatment1 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.
Group II: Dialectical Behavior Therapy Skills Group TrainingExperimental Treatment1 Intervention
The investigators will employ Dialectical Behavior Therapy Skills Training in order to experimentally manipulate maternal emotion dysregulation, our targeted mechanism.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Safety Planning Intervention
2017
N/A
~500

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,786 Previous Clinical Trials
16,359,198 Total Patients Enrolled
1 Trials studying Emotion Regulation
303 Patients Enrolled for Emotion Regulation
University of OregonOTHER
85 Previous Clinical Trials
44,088 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,913 Previous Clinical Trials
2,738,385 Total Patients Enrolled
4 Trials studying Emotion Regulation
410 Patients Enrolled for Emotion Regulation
~100 spots leftby Mar 2028