RECRUITING

Biomarkers Research in Anxiety for Validation and Efficacy

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Conditions

AutismAutism Spectrum Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Translational Biomarkers and Therapeutic Development for Very Young Children Diagnosed With Autism Spectrum Disorder and Co-occurring Anxiety

Quick Facts

Study Start:2024-04-02
Study Completion:2025-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06221176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 6 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Age between 3;0 and 6;11 years old
  2. * A diagnosis of autism spectrum disorder using DSM-5 diagnostic criteria
  3. * A diagnosis of anxiety disorder using DSM-5 diagnostic criteria
  4. * Use of fluent 2-3 word phrases or fluent speech (i.e., Module 2 or 3 for ADOS-2)
  5. * Cognitive ability (either verbal or non-verbal IQ) \> 80 using the DAS-2
  6. * 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.
  1. * Presence of seizures
  2. * Premature birth (\<36 weeks) or low birth weight (\<2500 gms)
  3. * 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)
  4. * Significant sensory or motor impairment (e.g., blindness)
  5. * Major physical abnormalities
  6. * Exposure to environmental factors that could contribute to neurocognitive delays (significant alcohol exposure in utero, extreme environmental deprivation)
  7. * Previous CBT for anxiety
  8. * Presence of conduct or oppositional defiant disorder or ADHD so severe as to interfere with the child's ability to take part in treatment
  9. * Presence of a primary presenting problem for which the intervention would be inappropriate (e.g., obsessive-compulsive disorder, severe mood disorder, suicidality)
  10. * Psychotic symptoms in the child or parents
  11. * Parent/caregiver who is not fluent in English or English is spoken in the home less than half of the time.

Contacts and Locations

Study Contact

Susan C Faja, PhD
CONTACT
16179194486
susan.faja@childrens.harvard.edu

Study Locations (Sites)

Boston Children's Hospital, Two Brookline Place
Brookline, Massachusetts, 02445
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-02
Study Completion Date2025-03-01

Study Record Updates

Study Start Date2024-04-02
Study Completion Date2025-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • Autism
  • Autism Spectrum Disorder