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This study implements an anxiety-focused, parent-led, therapist-assisted cognitive behavioral teletherapy for parents of youth with ASD and anxiety.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Intensity Therapist Assistance (LTA) | Experimental | Parents will receive four 30-minute supportive video calls with a therapist over the 12 weeks of treatment. |
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| Standard Therapist Assistance (STA) | Active Comparator | Parents will receive ten 60-minute supportive video calls with a therapist over the 12 weeks of treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Teletherapy LTA | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (before treatment), post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores 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). | Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores 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), Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38670664 | Derived | Guzick AG, Schneider SC, Kook M, Rose Iacono J, Weinzimmer SA, Quast T, Olsen SM, Hughes KR, Jellinek-Russo E, Garcia AP, Candelari A, Berry LN, Goin-Kochel RP, Goodman WK, Storch EA. Parent-Led Cognitive Behavioral Teletherapy for Anxiety in Autistic Youth: A Randomized Trial Comparing Two Levels of Therapist Support. Behav Ther. 2024 May;55(3):499-512. doi: 10.1016/j.beth.2023.08.008. Epub 2023 Sep 6. | |
| 38019467 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 | Aug 12, 2024 |
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| Cognitive Behavioral Teletherapy STA | Behavioral | 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. |
|
| Derived |
| Greenberg RL, Guzick AG, Schneider SC, Weinzimmer SA, Kook M, Perozo Garcia AB, Storch EA. Depressive Symptoms in Autistic Youth with Anxiety Disorders. J Dev Behav Pediatr. 2023 Dec 1;44(9):e597-e603. doi: 10.1097/DBP.0000000000001223. Epub 2023 Oct 11. |
| 34693989 | Derived | Elliott SJ, Marshall D, Morley K, Uphoff E, Kumar M, Meader N. Behavioural and cognitive behavioural therapy for obsessive compulsive disorder (OCD) in individuals with autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2021 Sep 3;9(9):CD013173. doi: 10.1002/14651858.CD013173.pub2. |
| FG001 | 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. |
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All participants (87) were randomly assigned to either the LTA or STA groups
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Individuals were randomly assigned to different conditions | Count of Participants | Participants |
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| Age, Continuous | Participants were randomly assigned to different conditions | Mean | Standard Deviation | years |
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| Sex: Female, Male | Participants were randomly assigned to different conditions | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Participants were randomly assigned to different conditions | Count of Participants | Participants |
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| Race (NIH/OMB) | Participants were randomly assigned to different conditions | Count of Participants | Participants |
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| Region of Enrollment | Participants were randomly assigned to different conditions | Number | participants |
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| 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 | 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. | Results for the post-treatment assessment | Posted | Mean | Standard Deviation | Score on a scale | Baseline (before treatment), post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported. |
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| 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). | count of participants who were classified as "much" or "very much improved" on the CGI-I at the end of treatment | Posted | Count of Participants | Participants | Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported. |
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| 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). | These scores are reported for the post-treatment assessment | Posted | Mean | Standard Deviation | Score on a scale | Baseline (before treatment), Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported. |
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Participants were enrolled in the study for up to 6 months, which corresponds to the time that adverse event data were collected
Definition of adverse event does not differ from that of clinicaltrails.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 48 | 0 | 48 | 0 | 48 |
| EG001 | 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. | 0 | 39 | 0 | 39 | 0 | 39 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Guzick | University of Pennsylvania | 215-573-3708 | andrew.guzick@pennmedicine.upenn.edu |
| Dec 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 |
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| Between 18 and 65 years |
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| >=65 years |
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