NCT03720795

Stepped-Care Cognitive-Behavioral Treatment for Youth With ASD and Anxiety

Completed NA Results posted Last updated 15 January 2025

What this trial tests

NA trial testing Stepped Care CBT in Cognitive Behavioral Therapy in 76 participants. Completed in 31 December 2022.

Timeline

1 February 2019

Primary endpoint
30 December 2021

31 December 2022

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	76
Start date	1 February 2019
Primary completion	30 December 2021
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Stepped Care CBT

Conditions studied

• Cognitive Behavioral Therapy — all drugs for Cognitive Behavioral Therapy →
• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
• Anxiety Disorders — all drugs for Anxiety Disorders →
• Obsessive-Compulsive Disorder — all drugs for Obsessive-Compulsive Disorder →

Sponsor

Baylor College of Medicine

Who can join

Adults 4 to 14, any sex, with Cognitive Behavioral Therapy or Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

7-item Pediatric Anxiety Rating Scale Primary · Baseline (before treatment), mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported.

Clinician rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 35.

Group	Value	95% CI
Stepped Care CBT	11.87	± 6.93

Clinical Global Impression-Improvement Primary · Mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported.

Clinician rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6= very much improved).

Group	Value	95% CI
Stepped Care CBT	42

Clinical Global Impression-Severity Secondary · Baseline (before treatment), mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported.

Clinician rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).

Group	Value	95% CI
Stepped Care CBT	1.88	± .98

Sponsor's own description

This study implements a parent-led, flexible, individually-tailored cognitive-behavioral intervention for children with ASD and anxiety.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.