Clinical trial NCT05665491: Role of Parent Interpretation Bias in the Transmission of Anxiety to Children
Official title: Parent Interpretation Bias as a Key Mechanism of Intergenerational Transmission of Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 300
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 NIMH's Strategic Plan, Objective 2.2 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 (e.g., 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


Eligibility criteria: Inclusion criteria for parent participants are:

1. Must have an ability to speak and understand English sufficiently to complete assessments
2. At least minimal anxiety severity (GAD-7 score \> 5)
3. At least a minimal level of interpretation bias (WSAP overall accuracy less than 70%)
4. No current psychiatric symptoms that would interfere with the individual's ability to provide consent or complete the research procedures
5. If receiving treatment, stable on medications or psychotherapy for 8 weeks
6. No severe suicidal ideation (PHQ-9 item 9 \> 1)
7. Own iOS or Android smartphone
8. Shared or full custody of child (for EMA assessment of parenting behaviors)

Inclusion criteria for child participants are:

1. Age 7 to 12
2. Must have an ability to speak and understand English sufficiently to complete assessments
3. No diagnosis of intellectual disability or autism spectrum disorder (per parent or clinician report)
4. No current psychiatric symptoms that would prevent informed consent or understanding of research procedures
5. Wechsler Abbreviated Scale of Intelligence (WASI) full-scale IQ equal to or greater than 80 to ensure understanding of study procedures
6. If receiving treatment, stable on medications or psychotherapy for 8 weeks
7. No severe suicidal ideation (PHQ-9 item 9 \> 1)

Primary outcomes:
measure: Parent behavior
timeFrame: 6 weeks
Secondary outcomes:
measure: Child interpretation bias
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Courtney Beard, PhD
role: PRINCIPAL_INVESTIGATOR
References: