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 an anxiety-focused, parent-led, therapist-assisted cognitive behavioral teletherapy for parents of youth with ASD and anxiety.
Detailed description
Anxiety disorders affect 50-80% of children with autism spectrum disorder (ASD) and are associated with significant life impairment and worsening trajectory without treatment. The most effective psychotherapy for anxiety in youth with and without ASD is cognitive behavioral therapy (CBT), but many families are not able to access CBT due to the cost, practicalities of attending treatment sessions, and limited availability of trained therapists. Alternative models of service delivery are greatly needed, with particular promise of parent-led therapist-assisted (PLTA) models and telehealth delivery formats. Parents may benefit from additional information regarding how to optimize the delivery of CBT for youths with ASD given the potential impact of ASD symptomology on core CBT skills. Thus, this project aims to improve access to anxiety-focused Parent-Led Therapist-Assisted CBT for parents of youth with ASD. Parent-led low-intensity treatment models can improve accessibility, efficiency, and mental health treatment cost. Lower intensity treatment models provide a treatment option that is less costly and burdensome for parents; it is understood that some individuals will respond to the first step and others will require additional treatment to achieve anxiety reduction. However, understanding how many families, and which families, can benefit from a lower intensity model has dramatic benefits for improving access, allocating more intensive services for those most in need, and reducing barriers (e.g., distance). Thus, this study will examine the effectiveness of two anxiety-focused PTLA CBT telehealth models: 1) low-intensity therapist assistance (LTA) and 2) standard therapist assistance (STA). Overall, this study will provide important information regarding the potential benefits of two different approaches to parent-led interventions for youth with ASD and anxiety when delivered via telehealth.
Interventions
BEHAVIORALCognitive Behavioral Teletherapy LTA
Participating families will receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the four videoconferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.
BEHAVIORALCognitive Behavioral Teletherapy STA
Participating families will also receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the ten videoconferencing sessions, therapists will guide the parent through the implementation of the program, including explaining materials, assisting to develop planned therapy activities with the child, and problem-solving as needed.
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 13 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-item Pediatric Anxiety Rating Scale | Baseline (before treatment), post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores 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 30. |
| Clinical Global Impression-Improvement | Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores 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), Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores 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
Participants by arm
| Arm | Count |
|---|---|
| Low-Intensity Therapist Assistance (LTA) Parents will receive four 30-minute supportive video calls with a therapist over the 12 weeks of treatment.
Cognitive Behavioral Teletherapy LTA: Participating families will receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the four videoconferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently. | 48 |
| Standard Therapist Assistance (STA) Parents will receive ten 60-minute supportive video calls with a therapist over the 12 weeks of treatment.
Cognitive Behavioral Teletherapy STA: Participating families will also receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the ten videoconferencing sessions, therapists will guide the parent through the implementation of the program, including explaining materials, assisting to develop planned therapy activities with the child, and problem-solving as needed. | 39 |
| Total | 87 |
Baseline characteristics
| Characteristic | Low-Intensity Therapist Assistance (LTA) | Standard Therapist Assistance (STA) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 48 Participants | 39 Participants | 87 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.1 years STANDARD_DEVIATION 1.8 | 10.3 years STANDARD_DEVIATION 1.8 | 10.2 years STANDARD_DEVIATION 1.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 11 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 27 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 11 Participants | 18 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 33 Participants | 23 Participants | 56 Participants |
| Region of Enrollment United States | 48 participants | 39 participants | 87 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 38 Participants | 30 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 39 |
| other Total, other adverse events | 0 / 48 | 0 / 39 |
| serious Total, serious adverse events | 0 / 48 | 0 / 39 |
Outcome results
Primary
6-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 30.
Time frame: Baseline (before treatment), post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.
Population: Results for the post-treatment assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low-Intensity Therapist Assistance (LTA) | 6-item Pediatric Anxiety Rating Scale | 11.35 Score on a scale | Standard Deviation 5.36 |
| Standard Therapist Assistance (STA) | 6-item Pediatric Anxiety Rating Scale | 10.26 Score on a scale | Standard Deviation 4.17 |
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: Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.
Population: count of participants who were classified as much or very much improved on the CGI-I at the end of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-Intensity Therapist Assistance (LTA) | Clinical Global Impression-Improvement | 21 Participants |
| Standard Therapist Assistance (STA) | Clinical Global Impression-Improvement | 23 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), Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.
Population: These scores are reported for the post-treatment assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low-Intensity Therapist Assistance (LTA) | Clinical Global Impression-Severity | 2.83 Score on a scale | Standard Deviation 1.07 |
| Standard Therapist Assistance (STA) | Clinical Global Impression-Severity | 2.59 Score on a scale | Standard Deviation 1.08 |