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NCT Number: NCT05665491

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

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

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Key information

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location status: Recruiting

Location contact

IreLee Ferguson, BA

CONTACT

[email protected]

617-844-4495

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for parent participants are:

  • 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)

Inclusion criteria

for child participants are:

  • 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)

Treatment and study plan

HabitWorks

Behavioral

Smartphone app-delivered interpretation bias intervention

Self-assessment

Behavioral

Self-assessment of parenting behaviors and anxiety symptoms

Primary outcomes

  1. Parent behavior

    Time frame: 6 weeks

    Coding of parent behaviors during parent-child interaction tasks

Secondary outcomes

  1. Child interpretation bias

    Time frame: 6 weeks

    3 items assessing expectations before and perceived performance after the parent-child interaction task

Study contacts

Contact information is provided by the study sponsor or research team.

Courtney Beard, PhD

CONTACT

[email protected]

617-855-3557

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Registry information

Official study title

Parent Interpretation Bias as a Key Mechanism of Intergenerational Transmission of Anxiety

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 27, 2022
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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