CBT for Anxiety in Children With Autism

NCT02725619 | Completed

• 2 other identifiers: 1211011144B1R01HD083881-01A1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial of Cognitive Behavioral Therapy (CBT) versus Psychoeducation and Supportive Therapy (PST) in children with Autism Spectrum Disorder and moderate to severe anxiety. The study will utilize fMRI to identify CBT-invoked changes in levels of activity/functional connectivity within the neural circuits involved in emotion regulation and social perception. Matched typically developing children without autism and/or anxiety will be scanned twice, 16 weeks apart, to enable interpretation of treatment-evoked change relative to normative development.

Conditions

Autism Spectrum Disorder; Anxiety

Outcome Measures

Primary Outcomes (5)

• Pediatric Anxiety Rating Scale (PARS)

  The PARS is a 50-item semi-structures interview of anxiety that will be conducted by an expert clinician. Endorsed symptoms are rated using 0-5 severity scale on 7 dimensions and a sum of scores for 5 of 7 dimensions constitute the total PARS score.

  change from baseline (week 0) at midpoint (week 8)

• Pediatric Anxiety Rating Scale (PARS)

  The PARS is a 50-item semi-structures interview of anxiety that will be conducted by an expert clinician. Endorsed symptoms are rated using 0-5 severity scale on 7 dimensions and a sum of scores for 5 of 7 dimensions constitute the total PARS score.

  change from baseline (week 0) at endpoint (week 16)

• Clinical Global Impression - Improvement (CGI-I) scale

  The CGI-I reflects the IE's assessment of overall change of the target symptoms from baseline on a scale from very much improved (score of 1) through no change (score of 4) to very much worse (score of 7). By convention, ratings of very much improved (score of 1) and much improved (score of 2) define positive response.

  change from baseline (week 0) at midpoint (week 8)

• Clinical Global Impression - Improvement (CGI-I) scale

  The CGI-I reflects the IE's assessment of overall change of the target symptoms from baseline on a scale from very much improved (score of 1) through no change (score of 4) to very much worse (score of 7). By convention, ratings of very much improved (score of 1) and much improved (score of 2) define positive response.

  change from baseline (week 0) at endpoint (week 16)

• blood oxygenation level dependent signal (BOLD) during down-regulation versus passive viewing of affective images.

  During a Functional Magnetic Resonance Imaging (fMRI), subjects will view neutral and affect-inducing pictures selected to be appropriate for children. During the emotion regulation task, subjects are asked to either simply look at the pictures or to down-regulate their emotional reaction to the picture.

  change from baseline (week 0) at endpoint (week 16)

Secondary Outcomes (1)

• blood oxygenation level dependent signal (BOLD) during emotional face perception task

  change from baseline (week 0) at endpoint (week 16)

Other Outcomes (1)

• blood oxygenation level dependent signal (BOLD) during perception of biological versus scrambled motion.

  change from baseline (week 0) at endpoint (week 16)

Study Arms (2)

Cognitive-Behavioral Therapy (CBT)

EXPERIMENTAL

CBT is dedicated to developing coping skills for managing anxiety such as emotion regulation and cognitive reappraisal. Children first learn and practice these skills during one-on-one, weekly sessions with experienced therapists and then apply this skills to navigate anxiety-producing situations as home, school and community. A key component of CBT involves exposure exercises, facing feared situations repeatedly while using the emotion regulation skills and remaining in the situations until anxiety is substantially reduced or become easy to tolerate. The feared situations are ordered from least to most distressing during therapy sessions in collaboration with the child and their parent. The unique combination of anxiety and ASD symptoms of social impairment and restricted/repetitive behavior is addressed in dedicated child and parent modules.

Behavioral: CBT

Psychoeducation and Supportive Therapy (PST)

ACTIVE COMPARATOR

Psychoeducation and Supportive Therapy includes learning about and discussing issues of diagnosis, treatment and educational services can also benefit children with ASD and their families. Each PST session starts with a review of events of the past week and include queries of topics such as school, interests, and family with an overarching goal of enhancing subjective well-being. The clinician, through the use of supportive, empathic and nondirective actions, will provide the participant with a "sounding-board" so that they can voice their concerns regarding specific problems that may require discussion and assistance. A major objective is to provide a clinical contact that enables participants to think through and discuss their concerns with a sympathetic adult. Subjects randomized to PST will be offered CBT after completion of the endpoint assessments.

Behavioral: PST

Interventions

CBT BEHAVIORAL

Also known as: Behavior therapy

Cognitive-Behavioral Therapy (CBT)

PST BEHAVIORAL

Also known as: Supportive psychotherapy

Psychoeducation and Supportive Therapy (PST)

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Boys and girls, ages 8 to 14 inclusive
• Diagnosis of autism spectrum disorder
• Diagnosis of anxiety disorder and clinically significant level of anxiety
• Full scale IQ and Verbal IQ \> 70
• Unmedicated or on stable medication with no planned changes for duration of study
• able to meet MRI safety (e.g., no metal medical implants) and data quality requirements (e.g., able to keep head still during scanning)

You may not qualify if:

• Presence of a known serious medical condition that would interfere with participation in the study
• Present of a current psychiatric disorder that requires immediate clinical attention
• A previous adequate trial of CBT for anxiety within the past 2 years.
• Note: This study will also recruit healthy volunteers (typically developing children without past or current mental health concerns).

Sponsors & Collaborators

• Yale University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

Related Publications (2)

• Sukhodolsky DG, Bloch MH, Panza KE, Reichow B. Cognitive-behavioral therapy for anxiety in children with high-functioning autism: a meta-analysis. Pediatrics. 2013 Nov;132(5):e1341-50. doi: 10.1542/peds.2013-1193. Epub 2013 Oct 28.

  PMID: 24167175 RESULT

• Sukhodolsky DG, Scahill L, Gadow KD, Arnold LE, Aman MG, McDougle CJ, McCracken JT, Tierney E, Williams White S, Lecavalier L, Vitiello B. Parent-rated anxiety symptoms in children with pervasive developmental disorders: frequency and association with core autism symptoms and cognitive functioning. J Abnorm Child Psychol. 2008 Jan;36(1):117-28. doi: 10.1007/s10802-007-9165-9. Epub 2007 Aug 3.

  PMID: 17674186 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder; Anxiety Disorders

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 1, 2016
• Study Start: April 1, 2016
• Primary Completion: April 5, 2022
• Study Completion: October 12, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)