Emotion RegulationNCT06463054
Testing an Intergenerational Model of Suicide Risk in Mother-child Dyads
A study testing Dialectical Behavior Therapy Skills Group Training and Safety Planning Intervention in people with Emotion Regulation, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- Dialectical Behavior Therapy Skills Group Training and Safety Planning Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Jennifer Wilson
Jennifer Stahler
About this study
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.
Read the detailed description
Suicide is now the 2nd leading cause of death among children ages 10-14 (CDC, 2022). This proposal responds to this public health crisis by testing an intergenerational mechanistic model of suicide risk in children while simultaneously testing a prevention and intervention approach that could be immediately useful. The investigators focus on children whose mothers have a history of suicidal behavior (intent, planning, attempt) as an especially vulnerable group with increased risk for an early and persistent course of suicidal thoughts and behaviors (STB). Theory and research point to emotion regulation (ER) as a potential intergenerational mechanism of suicide risk transmission from mother to child. Maternal ER affects child ER development via maternal emotion socialization, whereby maternal responses to child's emotions (validating/supportive vs. invalidating/unsupportive) shape how the child identifies, expresses, and modulates their emotions. The investigators theorize that maternal ER, a prerequisite for optimal maternal emotion socialization, serves as a clinically and etiologically significant pathway through which maternal history of suicidal behavior impacts the development of ER and emerging STB into adolescence. This proposal maximizes impact by leveraging a randomized controlled trial of Dialectical Behavior Therapy (DBT) Skills Training to improve maternal ER and testing a mechanistic model of suicide risk transmission from mothers to their children during a critical developmental juncture for the emergence and exacerbation of STB. Mothers will be randomized (1:1) to 6 months of either DBT Skills Training + Safety Planning Intervention (SPI) or SPI only. This design ensures all at-risk mothers receive SPI, an empirically supported intervention to enhance motivation, problem-solving, and mitigate suicide risk. The investigators hypothesize that mothers with a history of suicidal behavior and current ER difficulties who are randomly assigned to DBT Skills Training+SPI will experience improvements in ER compared to mothers assigned to SPI only. Furthermore, these improvements in maternal ER will predict meaningful decreases in child STB from late childhood into early adolescence through improved maternal emotion socialization and subsequent child ER development. The investigators will enroll 250 mother-child dyads with children ages 9-11 to retain a final sample of 225 dyads across two groups of mother-child dyads: (1) n=150 affected mothers (history of suicidal behavior + current ER difficulties) who will be randomly assigned to one of the two intervention conditions, and (2) n=75 nonaffected mothers (no history of suicidal behavior + no ER difficulties or psychiatric diagnosis since child's conception) to establish typical child ER development. Mother-child dyads will complete repeated multimodal assessments of ER, maternal emotion socialization, and STB over 24 months: baseline (intervention initiation), 3 months (intervention mid-point) 6 months (intervention termination), 12- and 24-months (post-intervention follow-up) when children will be ages 11-13, a high-risk time for STB. Findings from this study will identify intergenerational mechanisms of suicide risk and provide an intervention and prevention model for mitigating suicide risk in mother-child dyads.
- Conditions
- Emotion Regulation
- Being tested
- Dialectical Behavior Therapy Skills Group Training, Safety Planning Intervention
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behavior Therapy Skills Group TrainingBehavioural
The investigators will employ Dialectical Behavior Therapy Skills Training in order to experimentally manipulate maternal emotion dysregulation, the targeted mechanism.
Safety Planning InterventionBehavioural
Safety Planning Intervention (SPI) or SPI only for 6 months, such that all mothers with history of suicidal behavior + ER difficulties will receive SPI.
| Study group | Role | What they receive |
|---|---|---|
| Dialectical Behavior Therapy Skills Group Training | Experimental | The investigators will employ Dialectical Behavior Therapy Skills Training in order to experimentally manipulate maternal emotion dysregulation, our targeted mechanism. Receives: Behavioral: Dialectical Behavior Therapy Skills Group Training |
| Safety Planning Intervention | Experimental | Safety Planning Intervention (SPI) or SPI only for 6 months, such that all mothers with history of suicidal behavior + ER difficulties will receive SPI. Receives: Behavioral: Safety Planning Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Baseline, All Follow-up time points (3, 6, 12, and 24 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, All Follow-up time points (3, 6, 12, and 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Apr 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oregon, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Stephanie Stepp, University of Pittsburgh
- Investigators
- Stephanie D Step, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463054
- Sponsor's protocol ID
- STUDY23070061
- Other IDs
- R01MH132543
- Status last verified
- Jun 2026
- First submitted
- 23 May 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Intergenerational Model of Suicide Risk in Mother-child Dyads
- ClinicalTrials.gov ID
- NCT06463054
- Acronym / sponsor ID
- STUDY23070061
- Conditions
- Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Oregon, National Institute of Mental Health (NIMH)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Suicide is now the 2nd leading cause of death among children ages 10-14 (CDC, 2022). This proposal responds to this public health crisis by testing an intergenerational mechanistic model of suicide risk in children while simultaneously testing a prevention and intervention approach that could be immediately useful. The investigators focus on children whose mothers have a history of suicidal behavior (intent, planning, attempt) as an especially vulnerable group with increased risk for an early and persistent course of suicidal thoughts and behaviors (STB). Theory and research point to emotion regulation (ER) as a potential intergenerational mechanism of suicide risk transmission from mother to child. Maternal ER affects child ER development via maternal emotion socialization, whereby maternal responses to child's emotions (validating/supportive vs. invalidating/unsupportive) shape how the child identifies, expresses, and modulates their emotions. The investigators theorize that maternal ER, a prerequisite for optimal maternal emotion socialization, serves as a clinically and etiologically significant pathway through which maternal history of suicidal behavior impacts the development of ER and emerging STB into adolescence. This proposal maximizes impact by leveraging a randomized controlled trial of Dialectical Behavior Therapy (DBT) Skills Training to improve maternal ER and testing a mechanistic model of suicide risk transmission from mothers to their children during a critical developmental juncture for the emergence and exacerbation of STB. Mothers will be randomized (1:1) to 6 months of either DBT Skills Training + Safety Planning Intervention (SPI) or SPI only. This design ensures all at-risk mothers receive SPI, an empirically supported intervention to enhance motivation, problem-solving, and mitigate suicide risk. The investigators hypothesize that mothers with a history of suicidal behavior and current ER difficulties who are randomly assigned to DBT Skills Training+SPI will experience improvements in ER compared to mothers assigned to SPI only. Furthermore, these improvements in maternal ER will predict meaningful decreases in child STB from late childhood into early adolescence through improved maternal emotion socialization and subsequent child ER development. The investigators will enroll 250 mother-child dyads with children ages 9-11 to retain a final sample of 225 dyads across two groups of mother-child dyads: (1) n=150 affected mothers (history of suicidal behavior + current ER difficulties) who will be randomly assigned to one of the two intervention conditions, and (2) n=75 nonaffected mothers (no history of suicidal behavior + no ER difficulties or psychiatric diagnosis since child's conception) to establish typical child ER development. Mother-child dyads will complete repeated multimodal assessments of ER, maternal emotion socialization, and STB over 24 months: baseline (intervention initiation), 3 months (intervention mid-point) 6 months (intervention termination), 12- and 24-months (post-intervention follow-up) when children will be ages 11-13, a high-risk time for STB. Findings from this study will identify intergenerational mechanisms of suicide risk and provide an intervention and prevention model for mitigating suicide risk in mother-child dyads.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialectical Behavior Therapy Skills Group Training | Experimental | Behavioral: Dialectical Behavior Therapy Skills Group TrainingThe investigators will employ Dialectical Behavior Therapy Skills Training in order to experimentally manipulate maternal emotion dysregulation, our targeted mechanism. |
| Safety Planning Intervention | Experimental | Behavioral: Safety Planning InterventionSafety Planning Intervention (SPI) or SPI only for 6 months, such that all mothers with history of suicidal behavior + ER difficulties will receive SPI. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical Behavior Therapy Skills Group TrainingThe investigators will employ Dialectical Behavior Therapy Skills Training in order to experimentally manipulate maternal emotion dysregulation, the targeted mechanism. | Behavioural | Dialectical Behavior Therapy Skills Group Training |
| Safety Planning InterventionSafety Planning Intervention (SPI) or SPI only for 6 months, such that all mothers with history of suicidal behavior + ER difficulties will receive SPI. | Behavioural | Safety Planning Intervention |
Primary outcome
Child Suicidal Thoughts and Behaviors
Time frame: Baseline, All Follow-up time points (3, 6, 12, and 24 months
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)
Child Suicidal Thoughts and Behaviors
Time frame: Baseline, All Follow-up time points (3, 6, 12, and 24 months
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.
2 secondary outcomes
Child Mental Health Outcomes
Time frame: Baseline, All Follow-up time points (3, 6, 12, and 24 months)
Child Mental Health Outcomes
Time frame: Baseline, All Follow-up time points (3, 6, 12, and 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie D Step, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical Behavior Therapy Skills Group Training and Safety Planning Intervention in people with Emotion Regulation, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Wilson (412-952-7132, bresjl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Suicidal Thoughts and Behaviors (time frame: Baseline, All Follow-up time points (3, 6, 12, and 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.