Clinical trial NCT04111874: Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD
Official title: Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Behavioral Therapy
Autism Spectrum Disorder
Anxiety Disorders
Obsessive-Compulsive Disorder
Social Anxiety Disorder
Generalized Anxiety Disorder
Specific Phobia
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 87
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6-item Pediatric Anxiety Rating Scale
timeFrame: Baseline (before treatment), post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.
measure: Clinical Global Impression-Improvement
timeFrame: Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.
Secondary outcomes:
measure: Clinical Global Impression-Severity
timeFrame: Baseline (before treatment), Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
citation: 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.