Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05665491
Status:
RECRUITING
Last Update Posted:
2023-12-01
First Post:
2022-12-19
Brief Title:
Role of Parent Interpretation Bias in the Transmission of Anxiety to Children
Sponsor:
Mclean Hospital
Organization:
Mclean Hospital
Study Overview
Official Title:
Parent Interpretation Bias as a Key Mechanism of Intergenerational Transmission of Anxiety
Status:
RECRUITING
Status Verified Date:
2023-11
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:
Approximately 30 of children will experience an anxiety disorder making anxiety the most common mental health problem among children in the United States However few children receive treatment and even our most effective anxiety treatments leave up to half of children in need of additional intervention Despite the well-established role of parent anxiety in transmitting and maintaining child anxiety the lack of data on specific parent mechanisms underlying the intergenerational transmission of anxiety is a critical barrier to informing novel targets of personalized treatments Consistent with NIMHs Strategic Plan Objective 22 to understand risk factors and behavioral indicators of mental illness across the lifespan and to identify novel intervention targets based on knowledge of psychological mechanisms the current study focuses on interpretation bias the tendency to perceive threat in ambiguous situations The overall objective of this project is to empirically test a theoretical model of the intergenerational transmission of anxiety focused on parent interpretation bias as a root cause Our specific aims are to test theorized effects of parent interpretation bias on 1 parent behavior and 2 child interpretation bias and 3 evaluate potential moderators to refine theories of intergenerational transmission of anxiety and inform future personalized interventions Our central hypothesis is that parent interpretation bias influences child interpretation bias through its effects on maladaptive anxiety-promoting parenting behaviors such as accommodation and modeling of avoidant coping To test this hypothesis we will randomize 300 parents of children ages 7-12 to complete four weeks of a smartphone delivered interpretation bias manipulation vs a self-assessment smartphone app condition The interpretation bias intervention teaches parents to interpret ambiguous situations in a non-threatening manner via quick repeated practice and corrective feedback Before and after completing their randomly assigned condition parent-child dyads will complete self-report and behavioral tasks designed to elicit anxiety-promoting behaviors from parents depending upon their interpretation of the ambiguous situation speech and puzzle tasks Parents will also complete Ecological Momentary Assessment EMA of parenting behaviors to capture the time course of effects Finally we will examine downstream effects of the interpretation manipulation on child interpretation bias at pre- and post- visits We will test moderators eg parent anxiety and gender to refine theories of intergenerational transmission of anxiety and inform future personalized interventions The long-term goal of this work is to inform personalized mechanism-focused interventions to improve mental health outcomes for anxious children and their parents Future studies will translate knowledge gained from this project into a scalable treatment that can be implemented entirely remotely via smartphone thereby increasing access to care
Detailed Description:
None
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