AnxietyNCT05665491
Role of Parent Interpretation Bias in the Transmission of Anxiety to Children
A study testing HabitWorks and Self-Assessment in people with Anxiety, run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- HabitWorks and Self-Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2023to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 15Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
McLean Hospital
Belmont, Massachusetts, 02478
IreLee Ferguson, BA, 617-844-4495, iferguson1@mgb.org
About this study
Official title: Parent Interpretation Bias as a Key Mechanism of Intergenerational Transmission of Anxiety
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
- Being tested
- HabitWorks, Self-Assessment
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HabitWorksBehavioural
Smartphone app-delivered interpretation bias intervention
Self-AssessmentBehavioural
Self-assessment of parenting behaviors and anxiety symptoms
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self-Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent behavior
Coding of parent behaviors during parent-child interaction tasks
Measured: 6 weeks
Secondary outcomes (1)
Child interpretation bias
3 items assessing expectations before and perceived performance after the parent-child interaction task
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start28 Jul 2023
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney Beard, PhD, Mclean Hospital
- Investigators
- Courtney Beard, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665491
- Sponsor's protocol ID
- 2022p003245
- Status last verified
- Sep 2025
- First submitted
- 19 Dec 2022
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Chiffer MA, Dickstein DP, Itkin-Ofer R, Kuckertz JM, Ren B, Shin DE, Silverman AL, Webb CA, Beard C. Protocol for the Parent Anxiety Transmission and Habits (PATH) study: a randomised controlled trial testing parent interpretation bias as a key mechanism of intergenerational transmission of anxiety. BMJ Open. 2026 Jul 22;16(7):e119801. doi: 10.1136/bmjopen-2026-119801.
PubMed 42486525
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Interpretation Bias as a Key Mechanism of Intergenerational Transmission of Anxiety
- ClinicalTrials.gov ID
- NCT05665491
- Acronym / sponsor ID
- 2022p003245
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpretation bias manipulation | Experimental | Behavioral: HabitWorks, Behavioral: Self-AssessmentThe 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. |
| Self-Assessment | Placebo comparator | Behavioral: Self-AssessmentParents will complete the same repeated assessments, including EMA of parent behavior and weekly symptom surveys, but they will not complete the WSAP. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HabitWorksSmartphone app-delivered interpretation bias intervention | Behavioural | Interpretation bias manipulation |
| Self-AssessmentSelf-assessment of parenting behaviors and anxiety symptoms | Behavioural | Interpretation bias manipulation, Self-Assessment |
Primary outcome
Parent behavior
Time frame: 6 weeks
Coding of parent behaviors during parent-child interaction tasks
1 secondary outcome
Child interpretation bias
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Derived from this study: PubMed 42486525Chiffer MA, Dickstein DP, Itkin-Ofer R, Kuckertz JM, Ren B, Shin DE, Silverman AL, Webb CA, Beard C. Protocol for the Parent Anxiety Transmission and Habits (PATH) study: a randomised controlled trial testing parent interpretation bias as a key mechanism of intergenerational transmission of anxiety. BMJ Open. 2026 Jul 22;16(7):e119801. doi: 10.1136/bmjopen-2026-119801.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Courtney Beard, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HabitWorks and Self-Assessment in people with Anxiety, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Beard, PhD (617-855-3557, cbeard@mclean.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent behavior (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05665491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.