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N/A N=87 Randomized Single-blind Treatment

Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD

Cognitive Behavioral Therapy · Autism Spectrum Disorder · Anxiety Disorders · Obsessive-Compulsive Disorder · Social Anxiety Disorder

Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: 6-item Pediatric Anxiety Rating Scale — 11.35; 10.26 Score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Cognitive Behavioral Teletherapy LTA (Behavioral); Cognitive Behavioral Teletherapy STA (Behavioral)
Age
Pediatric · 7+ yrs
Sex
All
Sponsor
Baylor College of Medicine
Primary completion
Dec 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
6-item Pediatric Anxiety Rating Scale
11.35; 10.26
PRIMARY
Clinical Global Impression-Improvement
21; 23
SECONDARY
Clinical Global Impression-Severity
2.83; 2.59

Summary

This study implements an anxiety-focused, parent-led, therapist-assisted cognitive behavioral teletherapy for parents of youth with ASD and anxiety.

Eligibility Criteria

Inclusion Criteria

  • Child is between the ages 7-13 years at consent/assent.
  • The child meets criteria for ASD.
  • The child meets criteria for clinically significant anxiety and/or OCD symptoms.
  • Anxiety and/or OCD is the primary presenting problem.
  • One parent/guardian is able and willing to participate.
  • The child has a Full Scale and Verbal Comprehension Intelligence Quotient >70.
  • The child is able to communicate verbally.
  • Participants must reside in Texas and parents must be in the state of Texas when taking calls.

Exclusion Criteria

  • The child has a diagnosis of lifetime DSM-5 bipolar disorder, psychotic disorder, and/or intellectual disability.
  • The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention.
  • The child is receiving concurrent psychotherapy for anxiety.
  • Initiation of a psychotropic medication less than 4 weeks prior to study enrollment or a stimulant/psychoactive medication less than 2 weeks prior to study enrollment.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04111874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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