Anxiety Disorders, Autism Spectrum Disorder, Cognitive Behavioral Therapy, Generalized Anxiety Disorder, Obsessive-Compulsive Disorder, Social Anxiety Disorder, Specific Phobia
Conditions
Brief summary
This study implements a parent-led, flexible, individually-tailored cognitive-behavioral intervention for children with ASD and anxiety.
Detailed description
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.
Interventions
BEHAVIORALStepped 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.
Sponsors
Baylor College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The rater is unaware of treatment status, that is if the child continues to receive treatment after Step 1 (versus being in maintenance).
Intervention model description
Single group observational.
Eligibility
Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Child is between the ages 4-14 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 attend. * The child has a Full Scale and Verbal Comprehension Intelligence Quotient \>70.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-item Pediatric Anxiety Rating 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. | 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. |
| Clinical Global Impression-Improvement | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression-Severity | 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). |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 76 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 3 Month Follow Up | Lost to Follow-up | 2 |
| Phase 1 | Lost to Follow-up | 4 |
| Phase 1 | Other | 1 |
| Phase 1 | Protocol Violation | 1 |
| Phase 1 | Withdrawal by Subject | 6 |
| Phase 2 | Lost to Follow-up | 5 |
| Phase 2 | Protocol Violation | 2 |
| Phase 2 | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Stepped-Care CBT |
|---|---|
| Age, Categorical <=18 years | 76 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 8.86 years STANDARD_DEVIATION 2.79 |
| Clinical Global Impressions - Severity | 3.66 units on a scale STANDARD_DEVIATION 1.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Pediatric Anxiety Rating Scale (PARS) | 21.54 units on a scale STANDARD_DEVIATION 3.91 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 57 Participants |
| Region of Enrollment United States | 76 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 76 |
| other Total, other adverse events | 0 / 76 |
| serious Total, serious adverse events | 0 / 76 |
Outcome results
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.
Time frame: Baseline (before treatment), mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported.
Population: 48 participants completed either the maintenance phase or Step Two of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care CBT | 7-item Pediatric Anxiety Rating Scale | 11.87 Score on a scale | Standard Deviation 6.93 |
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).
Time frame: Mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported.
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stepped Care CBT | Clinical Global Impression-Improvement | 42 Participants |
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).
Time frame: Baseline (before treatment), mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported.
Population: 48 participants either completed Step Two or the maintenance phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care CBT | Clinical Global Impression-Severity | 1.88 Score on a scale | Standard Deviation 0.98 |