Testing an Intergenerational Model of Suicide Risk in Mother-child Dyads

Emotion Regulation Clinical Trial

Official title:

Testing an Intergenerational Model of Suicide Risk in Mother-child Dyads

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06463054
• Other study ID #: STUDY23070061
• Secondary ID: R01MH132543
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: June 2024
• Source: University of Pittsburgh
• Contact: Jennifer Wilson
• Phone: 412-952-7132
• Email: bresjl[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2028
• Est. primary completion date: March 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Emotion Regulation
• Suicide

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH), University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Suicidal Thoughts and Behaviors	Suicidal thoughts and behaviors will be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).	Baseline, All Follow-up time points (3, 6, 12, and 24 months
Primary	Child Suicidal Thoughts and Behaviors	Suicidal thoughts and behaviors will be assessed the Intensity of Suicide Ideation Scale (SIS; PhenX Toolkit).	Baseline, All Follow-up time points (3, 6, 12, and 24 months
Secondary	Child Mental Health Outcomes	Child mental health problems will assessed using the Youth Self-Report (YSR; child reports).	Baseline, All Follow-up time points (3, 6, 12, and 24 months)
Secondary	Child Mental Health Outcomes	Child mental health problems will assessed using Child Behavior Checklist (CBCL; mother reports).	Baseline, All Follow-up time points (3, 6, 12, and 24 months)