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

Sponsor
Mclean Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05665491
Collaborator
(none)
300
2
51

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: HabitWorks
  • Behavioral: Self-Assessment
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Parent Interpretation Bias as a Key Mechanism of Intergenerational Transmission of Anxiety
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Nov 30, 2027
Anticipated Study Completion Date :
Nov 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interpretation bias manipulation

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
Smartphone app-delivered interpretation bias intervention

Behavioral: Self-Assessment
Self-assessment of parenting behaviors and anxiety symptoms

Placebo Comparator: Self-Assessment

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
Self-assessment of parenting behaviors and anxiety symptoms

Outcome Measures

Primary Outcome Measures

  1. Parent behavior [6 weeks]

    Coding of parent behaviors during parent-child interaction tasks

Secondary Outcome Measures

  1. Child interpretation bias [6 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mclean Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Courtney Beard, PhD, Associate Professor, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT05665491
Other Study ID Numbers:
  • 2022p003245
First Posted:
Dec 27, 2022
Last Update Posted:
Dec 27, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 27, 2022