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

Primary Purpose

Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HabitWorks
Self-Assessment
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anxiety

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Interpretation bias manipulation

    Self-Assessment

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Parent behavior
    Coding of parent behaviors during parent-child interaction tasks

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 19, 2022
    Last Updated
    December 19, 2022
    Sponsor
    Mclean Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05665491
    Brief Title
    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

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2027 (Anticipated)
    Study Completion Date
    November 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mclean Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Interpretation bias manipulation
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Self-Assessment
    Arm Type
    Placebo Comparator
    Arm Description
    Parents will complete the same repeated assessments, including EMA of parent behavior and weekly symptom surveys, but they will not complete the WSAP.
    Intervention Type
    Behavioral
    Intervention Name(s)
    HabitWorks
    Intervention Description
    Smartphone app-delivered interpretation bias intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Self-Assessment
    Intervention Description
    Self-assessment of parenting behaviors and anxiety symptoms
    Primary Outcome Measure Information:
    Title
    Parent behavior
    Description
    Coding of parent behaviors during parent-child interaction tasks
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Child interpretation bias
    Description
    3 items assessing expectations before and perceived performance after the parent-child interaction task
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Courtney Beard, PhD
    Phone
    617-855-3557
    Email
    cbeard@mclean.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    All de-identified data will be published by the end of the project period or as papers are published, in repositories such as the Open Science Framework. Datasets will be managed and distributed in accordance with FAIR Guiding Principles (best practices for Findability, Accessibility, Interoperability, and Reusability) to maximize the potential for reuse of the data by other investigators. We will ensure study transparency, describing recruitment, enrollment, and randomization in a Consolidated Standards of Reporting Trials (CONSORT) diagram and providing detailed descriptions of experimental arms. The PI will prepare and submit data to clinicaltrials.gov and share data via the NDCT.

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

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