Biomarkers Research in Anxiety for Validation and Efficacy

NCT06221176 | Recruiting

• 1 other identifier: P00046792
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Autism; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Spence Preschool Anxiety Scale (SPAS) or Spence Anxiety Scale (SCAS) Parent Report

  Parents of children ages 3 to 5 will complete the SPAS and parents of 6 year old children will complete the SCAS. These are questionnaires designed to assess the severity of anxiety symptoms in preschool-aged and school-aged children. Scores range from 0-136 with higher scores indicating greater anxiety.

  At baseline enrollment visit and post intervention approximately 20 weeks later

Secondary Outcomes (3)

• Behavior Assessment System for Children (BASC-3)

  At baseline enrollment visit and post intervention approximately 20 weeks later

• Pediatric Anxiety Rating Scale (PARS)

  At baseline enrollment visit and post intervention approximately 20 weeks later

• Clinical Global Impression of Anxiety (CGI-A) Interview

  At baseline enrollment visit and post intervention approximately 20 weeks later

Other Outcomes (6)

• Coping Questionnaire (CQ)

  At baseline enrollment visit and post intervention approximately 20 weeks later

• Family Life Impairment Scale (FLIS)

  At baseline enrollment visit and post intervention approximately 20 weeks later

• Resting EEG Alpha Asymmetry

  At baseline, 3-4 weeks later, and at post (approximately 20 weeks later)

Study Arms (1)

Intervention Group

EXPERIMENTAL

Being Brave

Behavioral: Being Brave

Interventions

Being Brave 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.

Intervention Group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital, Two Brookline Place

Brookline, Massachusetts, 02445, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Susan C Faja, PhD

CONTACT

16179194486; susan.faja@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 24, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)