Biomarkers Research in Anxiety for Validation and Efficacy

NCT ID: NCT06221176

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-02
• Study Completion Date: 2025-08-01

Brief Summary

A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).

Detailed Description

A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).

The main questions the study aims to answer are:

• To evaluate the stability of each potential biomarker over a 3-4-week retest period. The biomarkers are hypothesized to have adequate stability (ICC: > .5) in the absence of intervention.
• To determine which baseline biomarker scores predict response to a manualized cognitive behavioral therapy (CBT) program for treating anxiety, Being Brave.
• To determine which biomarkers are sensitive to treatment response.

Conditions

Autism; Autism Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Intervention Group

Being Brave

Group Type: EXPERIMENTAL

Being Brave

Intervention Type: BEHAVIORAL

Being Brave is a manualized cognitive-behavioral (CBT) intervention and includes several features that are well-aligned with the needs of autistic children: (1) an intensive parent component; (2) use of visual aids to lay out coping plans and exposure hierarchies, psychoeducation about recognizing fear and anxiety, and scripted language for coping; (3) repeated practice of well-rehearsed coping plans for novel or challenging situations; and (4) exposure exercises for social anxiety and practice of basic social skills. The intervention includes 16 weekly sessions (1 hour each). Delivery of Being Brave is flexible to allow for additional or less practice or exposure opportunities.

Interventions

Being Brave

Being Brave is a manualized cognitive-behavioral (CBT) intervention and includes several features that are well-aligned with the needs of autistic children: (1) an intensive parent component; (2) use of visual aids to lay out coping plans and exposure hierarchies, psychoeducation about recognizing fear and anxiety, and scripted language for coping; (3) repeated practice of well-rehearsed coping plans for novel or challenging situations; and (4) exposure exercises for social anxiety and practice of basic social skills. The intervention includes 16 weekly sessions (1 hour each). Delivery of Being Brave is flexible to allow for additional or less practice or exposure opportunities.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age between 3;0 and 6;11 years old
• A diagnosis of autism spectrum disorder using DSM-5 diagnostic criteria
• A diagnosis of anxiety disorder using DSM-5 diagnostic criteria
• Use of fluent 2-3 word phrases or fluent speech (i.e., Module 2 or 3 for ADOS-2)
• Cognitive ability (either verbal or non-verbal IQ) > 80 using the DAS-2
• A parent/guardian who is willing/able to participate and respond to interviews/surveys in English and willing/able to participate in Being Brave parent training in English and support homework activities.

Exclusion Criteria

• Presence of seizures
• Premature birth (<36 weeks) or low birth weight (<2500 gms)
• Known genetic or medical disorders (e.g., Fragile X), or injuries (e.g., stroke) with implications for the nervous system or that require regular psychoactive medication that alter EEG/RSA/EDR signal (e.g., anti-convulsants)
• Significant sensory or motor impairment (e.g., blindness)
• Major physical abnormalities
• Exposure to environmental factors that could contribute to neurocognitive delays (significant alcohol exposure in utero, extreme environmental deprivation)
• Previous CBT for anxiety
• Presence of conduct or oppositional defiant disorder or ADHD so severe as to interfere with the child's ability to take part in treatment
• Presence of a primary presenting problem for which the intervention would be inappropriate (e.g., obsessive-compulsive disorder, severe mood disorder, suicidality)
• Psychotic symptoms in the child or parents
• Parent/caregiver who is not fluent in English or English is spoken in the home less than half of the time.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Susan Faja

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Boston Children's Hospital, Two Brookline Place

Brookline, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Susan C Faja, PhD

Role: CONTACT

susan.faja@childrens.harvard.edu

16179194486

Facility Contacts

Susan Faja, PhD

Role: primary

susan.faja@childrens.harvard.edu

16179194486

Other Identifiers

P00046792

Identifier Type: -

Identifier Source: org_study_id