Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study implements a parent-led, flexible, individually-tailored cognitive-behavioral intervention for children with ASD and anxiety.
Autism spectrum disorder (ASD) affects as many as 1 out of 59 individuals, with many higher-functioning youth not diagnosed until school-age or later. This equates to ~102,000 children under the age of 14 years in the state of Texas alone. Significant impairment in social and adaptive functioning are common, as are comorbid behavioral health disorders, with anxiety disorders affecting between 50-80% of youth with ASD. Given the relative frequency of anxiety disorders among children with ASD, the associated impairment, and worsening trajectory over time without intervention, there is a great need for treatment that specifically addresses anxiety-related symptoms in ASD. Cognitive-behavioral therapy (CBT) has been established as a first-line treatment for anxiety disorders among youth with and without ASD. A particular form of CBT, Behavioral Intervention for Anxiety in Children with ASD (BIACA), has demonstrated efficacy in a number of studies. However, treatment is delivered by therapists as "full-packages" (i.e., 12-16 clinic sessions), which can be therapist-intensive, costly, impractical for families, and not responsive to parental preferences. Alternatives approaches, such as parent-led, stepped-care models that improve accessibility, are efficient, provide personalized care, and lower mental health treatment cost, are greatly needed. Stepped-care models provide a lower-intensity first step (e.g., parent-led, less costly, and more convenient for parents) as the initial treatment with the assumption that a proportion of individuals will respond to the first step and others will need to step up to more intensive treatment. Matching treatment to families' needs and tailoring subsequent treatment may be an efficient and effective approach, as well as consistent with parents' desire to help their child. Given this, together with the substantial impairment associated with clinical anxiety in individuals with ASD across the age span, this study implements a parent-led, flexible, individually-tailored cognitive-behavioral intervention for children with ASD and anxiety.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stepped Care CBT | Other | Stepped Care CBT consists of two main steps. Step One involves 4 parent-led, therapist-assisted treatment sessions, up to 45 minutes each, over an 8-week period. Participants who do not show significant improvement in symptom severity at the end of Step One, are then 'stepped up' to receive Step Two, which involves 12 weekly, therapist-led, parent-assisted treatment sessions, up to 60 minutes each. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stepped Care CBT | Behavioral | Stepped Care CBT is a multi-method, parent-led approach, consisting of two main steps. Step one involves a "low-intensity" delivery of CBT, consisting of more flexible, parent-led, at-home treatment. Participants who do not show improvement in symptom severity at the end of Step One, are then "stepped up" to receive Step Two. Step two involves a "high intensity" delivery of CBT, consisting of therapist-led, parent-assisted weekly treatment sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| 7-item Pediatric Anxiety Rating Scale | 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. | Baseline (before treatment), mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported. |
| Clinical Global Impression-Improvement | Clinician rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6= very much improved). | Mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression-Severity | Clinician rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms). | Baseline (before treatment), mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were not pre-assigned to groups. If participants did not respond to Step One of treatment, then they were stepped up to Step Two. Those who did respond to treatment at Step One then they entered a maintenance phase
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stepped Care CBT | Stepped Care CBT consists of two main steps. Step One involves 4 parent-led, therapist-assisted treatment sessions, up to 45 minutes each, over an 8-week period. Participants who do not show significant improvement in symptom severity at the end of Step One, are then 'stepped up' to receive Step Two, which involves 12 weekly, therapist-led, parent-assisted treatment sessions, up to 60 minutes each. Stepped Care CBT: Stepped Care CBT is a multi-method, parent-led approach, consisting of two main steps. Step one involves a "low-intensity" delivery of CBT, consisting of more flexible, parent-led, at-home treatment. Participants who do not show improvement in symptom severity at the end of Step One, are then "stepped up" to receive Step Two. Step two involves a "high intensity" delivery of CBT, consisting of therapist-led, parent-assisted weekly treatment sessions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1 |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 14, 2024 |
Not provided
Single group observational.
Not provided
Not provided
The rater is unaware of treatment status, that is if the child continues to receive treatment after Step 1 (versus being in maintenance).
Not provided
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Phase 2 |
|
|
| 3 Month Follow Up |
|
|
Of the 76 participants, 64 entered phase two of the study. Of these 64, 20 entered the maintenance phase (were responders to Step One) and 44 stepped up to Step Two
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Stepped-Care CBT | Stepped Care CBT consists of two main steps. Step One involves 4 parent-led, therapist-assisted treatment sessions, up to 45 minutes each, over an 8-week period. Participants who do not show significant improvement in symptom severity at the end of Step One, are then 'stepped up' to receive Step Two, which involves 12 weekly, therapist-led, parent-assisted treatment sessions, up to 60 minutes each. Stepped Care CBT: Stepped Care CBT is a multi-method, parent-led approach, consisting of two main steps. Step one involves a "low-intensity" delivery of CBT, consisting of more flexible, parent-led, at-home treatment. Participants who do not show improvement in symptom severity at the end of Step One, are then "stepped up" to receive Step Two. Step two involves a "high intensity" delivery of CBT, consisting of therapist-led, parent-assisted weekly treatment sessions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Clinical Global Impressions - Severity | Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||||
| Pediatric Anxiety Rating Scale (PARS) | 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. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 7-item Pediatric Anxiety Rating Scale | 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. | 48 participants completed either the maintenance phase or Step Two of treatment | Posted | Mean | Standard Deviation | Score on a scale | Baseline (before treatment), mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported. |
|
|
| |||||||||||||||||||||||||
| Primary | Clinical Global Impression-Improvement | Clinician rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6= very much improved). | 48 participants were considered completers of Step 2 or the Maintenance Phase. The count is the number of participants that are considered "much improved" or "very much improved" on the CGI-I | Posted | Count of Participants | Participants | Mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported. |
| ||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression-Severity | Clinician rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms). | 48 participants either completed Step Two or the maintenance phase. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (before treatment), mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported. |
|
|
Participants were enrolled in the study for up to 9 months, which is the same time as when adverse event data were collected
The definition of an adverse event is the same as found on clinicaltrials.gov
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stepped Care CBT | Stepped Care CBT consists of two main steps. Step One involves 4 parent-led, therapist-assisted treatment sessions, up to 45 minutes each, over an 8-week period. Participants who do not show significant improvement in symptom severity at the end of Step One, are then 'stepped up' to receive Step Two, which involves 12 weekly, therapist-led, parent-assisted treatment sessions, up to 60 minutes each. Stepped Care CBT: Stepped Care CBT is a multi-method, parent-led approach, consisting of two main steps. Step one involves a "low-intensity" delivery of CBT, consisting of more flexible, parent-led, at-home treatment. Participants who do not show improvement in symptom severity at the end of Step One, are then "stepped up" to receive Step Two. Step two involves a "high intensity" delivery of CBT, consisting of therapist-led, parent-assisted weekly treatment sessions. All Adverse Event reports are combined here as there is only one group that is split into two milestones of "Entered Maintenance" or "Stepped Up to Step 2" | 0 | 76 | 0 | 76 | 0 | 76 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Storch | Baylor College of Medicine | (713) 798-3579 | eric.storch@bcm.edu |
| Sep 4, 2024 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001008 | Anxiety Disorders |
| D009771 | Obsessive-Compulsive Disorder |
| D000072861 | Phobia, Social |
| D000098647 | Generalized Anxiety Disorder |
| C562465 | Phobia, Specific |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|