Ignite Creation Date:
2024-07-17 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463054
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-23
Brief Title:
Testing an Intergenerational Model of Suicide Risk in Mother-child Dyads
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Testing an Intergenerational Model of Suicide Risk in Mother-child Dyads
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs emotions validatingsupportive vs invalidatingunsupportive 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 11 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 TrainingSPI 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 n150 affected mothers history of suicidal behavior current ER difficulties who will be randomly assigned to one of the two intervention conditions and 2 n75 nonaffected mothers no history of suicidal behavior no ER difficulties or psychiatric diagnosis since childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH132543 | NIH | None | None |