Boston Children's Hospital, Two Brookline Place
Brookline, Massachusetts, 02445, United States
NCT Number: NCT06221176
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).
Looking for future studies?
Notify Me3 year–6 year
All sexes
Interventional
Not applicable
Brookline, Massachusetts, 02445, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At baseline enrollment visit and post intervention approximately 20 weeks later
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.
Time frame: At baseline enrollment visit and post intervention approximately 20 weeks later
The BASC-3 measures adaptive and problem behaviors in the community and home setting. It has a strong foundation in theory and research. Scores range from 20-120 with higher scores indicating greater anxiety.
Time frame: At baseline enrollment visit and post intervention approximately 20 weeks later
The PARS is a checklist which the independent evaluating clinician completes based upon parent interview. The measure is designed to assess the severity of anxiety symptoms associated with social phobia, separation anxiety disorder, and generalized anxiety disorder. Scores range from 0-25 with higher scores indicating greater anxiety.
Time frame: At baseline enrollment visit and post intervention approximately 20 weeks later
The CGI-A assesses severity and improvement of anxiety using a 7-point Likert scale (from "very much better" to "very much worse"). Based on information collected from the KSADSE, PARS, and Spence, the clinician will rate the global severity of the child's global anxiety and of each individual anxiety disorder. Scores range from 0-8 with higher scores indicating greater anxiety.
Time frame: At baseline enrollment visit and post intervention approximately 20 weeks later
To assess changes in a child's ability to manage specific anxiety-provoking situations, parents rate up to six specific anxiety-provoking situations for their child. Scores range from 6-42 with lower scores indicating lower ability to cope with anxiety.
Time frame: At baseline enrollment visit and post intervention approximately 20 weeks later
To assess the extent to which child behavior limits participation in activities typical of families with young children, parents will complete this measure. Scores range from 0-38 with higher scores indicating greater impact of child behavior on family functioning.
Time frame: At baseline, 3-4 weeks later, and at post (approximately 20 weeks later)
Continuous EEG will be collected while children watch non-social videos for a 4 minute baseline period and again after a brief challenge task (working memory, conversation about feelings). The dependent variable will be EEG alpha power asymmetry (i.e., difference in alpha power between the left and right frontal recording sites)
Time frame: At baseline, 3-4 weeks later, and at post (approximately 20 weeks later)
ERPs will be collected while children view digitized and standardized photos of neutral, fearful, angry, and happy expressions (50 per condition). Each trial will consist of a 100ms baseline, 500ms face stimulus, 1200ms post-stimulus period, and variable inter-trial interval of 500-1000ms. The dependent variable will be the ERP mean amplitude at the late positive potential measured between 700-1200ms over anterior leads.
Time frame: At baseline, 3-4 weeks later, and at post (approximately 20 weeks later)
EDR will be collected during a task includes acquisition trials that pair a conditioned stimulus (CS+; a geometric shape) with an aversive tone (i.e., unconditioned stimulus). The second conditioned stimulus (CS-; a different geometric shape) is presented alone. The CS+ and CS- are counterbalanced across children and will be unique at each time point. The Pavlovian Conditioning and Extinction Task will be conducted to measure the rate of EDR habituation during the extinction period. In addition, EDR levels will be explored during a series of challenges in different domains paired with non-challenging tasks that control for the psychomotor demands of the challenge task.
Time frame: At baseline, 3-4 weeks later, and at post (approximately 20 weeks later)
RSA will be collected during a validated protocol for assessing autonomic nervous system reactivity in children ages 3 to 6. The protocol includes a series of challenges in different domains paired with non-challenging tasks that control for the psychomotor demands of the challenge task. RSA will also be explored during the extinction period of a conditioning task.
Boston Children's Hospital
Other
Translational Biomarkers and Therapeutic Development for Very Young Children Diagnosed With Autism Spectrum Disorder and Co-occurring Anxiety
Acronym: BRAVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03778827
Autism, Autism Spectrum Disorder
Stanford, California, United States
View Trial DetailsNCT04089579
Autism, Autism Spectrum Disorder
Durham, North Carolina, United States
View Trial DetailsNCT03204786
ASD, Autism
Stanford, California, United States
View Trial DetailsNCT05565482
Autism, Autism Spectrum Disorder
Plainwell, Michigan, United States
View Trial Details