Role of Parent Interpretation Bias in the Transmission of Anxiety to Children

NCT05665491 | Recruiting

• 1 other identifier: 2022p003245
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Parent behavior

  Coding of parent behaviors during parent-child interaction tasks

  6 weeks

Secondary Outcomes (1)

• Child interpretation bias

  6 weeks

Study Arms (2)

Interpretation bias manipulation

EXPERIMENTAL

The primary component of the interpretation bias manipulation is the Word Sentence Association Paradigm (WSAP) delivered by the HabitWorks smartphone app. Users complete 50 trials in each exercise (approximately 5 min) and are prompted to complete 3 exercises per week (12 total over 4 weeks). The WSAP incorporates repetitive and quick practice, increasing individuals' awareness of their cognitive biases and shifting of their automatic responses.

Behavioral: HabitWorks; Behavioral: Self-Assessment

Self-Assessment

PLACEBO COMPARATOR

Parents will complete the same repeated assessments, including EMA of parent behavior and weekly symptom surveys, but they will not complete the WSAP.

Behavioral: Self-Assessment

Interventions

HabitWorks BEHAVIORAL

Smartphone app-delivered interpretation bias intervention

Interpretation bias manipulation

Self-Assessment BEHAVIORAL

Self-assessment of parenting behaviors and anxiety symptoms

Interpretation bias manipulation; Self-Assessment

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have an ability to speak and understand English sufficiently to complete assessments
• At least minimal anxiety severity (GAD-7 score \> 5)
• At least a minimal level of interpretation bias (WSAP overall accuracy less than 70%)
• No current psychiatric symptoms that would interfere with the individual's ability to provide consent or complete the research procedures
• If receiving treatment, stable on medications or psychotherapy for 8 weeks
• No severe suicidal ideation (PHQ-9 item 9 \> 1)
• Own iOS or Android smartphone
• Shared or full custody of child (for EMA assessment of parenting behaviors)
• Age 7 to 12
• Must have an ability to speak and understand English sufficiently to complete assessments
• No diagnosis of intellectual disability or autism spectrum disorder (per parent or clinician report)
• No current psychiatric symptoms that would prevent informed consent or understanding of research procedures
• Wechsler Abbreviated Scale of Intelligence (WASI) full-scale IQ equal to or greater than 80 to ensure understanding of study procedures
• If receiving treatment, stable on medications or psychotherapy for 8 weeks
• No severe suicidal ideation (PHQ-9 item 9 \> 1)

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Diagnostic Self Evaluation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Courtney Beard, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Beard, PhD

CONTACT

617-855-3557; cbeard@mclean.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 27, 2022
• Study Start: July 28, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)