Clinical trial NCT06463054: Testing an Intergenerational Model of Suicide Risk in Mother-child Dyads
Official title: Testing an Intergenerational Model of Suicide Risk in Mother-child Dyads
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotion Regulation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Oregon
name: National Institute of Mental Health (NIMH)
First posted: 2024-06-17
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child Suicidal Thoughts and Behaviors
timeFrame: Baseline, All Follow-up time points (3, 6, 12, and 24 months
measure: Child Suicidal Thoughts and Behaviors
timeFrame: Baseline, All Follow-up time points (3, 6, 12, and 24 months
Secondary outcomes:
measure: Child Mental Health Outcomes
timeFrame: Baseline, All Follow-up time points (3, 6, 12, and 24 months)
measure: Child Mental Health Outcomes
timeFrame: Baseline, All Follow-up time points (3, 6, 12, and 24 months)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Stephanie D Step, PhD
role: PRINCIPAL_INVESTIGATOR
References: