Clinical trial NCT05588570: Coaching Children With Anxiety and Autism Through Telehealth
Official title: Coaching Children With Anxiety and Autism Through Telehealth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Anxiety
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 17
Sex: ALL
Minimum age (years): 48
Maximum age (years): 107
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine a telehealth parenting intervention to reduce anxiety in 20 families of children between 4 and 8 years old with autism and anxiety. Caregivers and children complete 12 telehealth treatment sessions. Caregivers and children will complete pre tests, post tests, and 3 month followup assessments that include observations, heart rate monitoring, and caregiver ratings.

Detailed description: This study will examine the feasibility and initial efficacy of a telehealth adaptation of a parenting intervention to reduce anxiety (Coaching Approach behavior Leading by Modeling; CALM) amongst 20 families of children between 4 and 8 years old with autism and anxiety. Our time limited telehealth-delivered adaptation of CALM is called CAT (Coaching Children with Anxiety and Autism through Telehealth). The study will utilize an open trial design with pre, post, and 3-month follow-up assessments including observational measures, physiological measures, and caregiver ratings.

Eligibility criteria: Inclusion Criteria:

* Child participants must:
* Be between 4:0-8:11 years old
* Have clinically significant caregiver-report symptoms of anxiety on the Parent-Rated Anxiety Scale for ASD (PRAS-ASD)
* Have a primary anxiety concern on the Anxiety Disorders Interview Schedule for Autism Spectrum and Developmental Disorders: Parent Version (ADIS/ASA)
* Have an ASD diagnosis made by a qualified diagnostician
* Have a cognitive level of 48 months on the Wechsler Preschool \& Primary Scale of Intelligence-Fourth Edition (WPPSI-IV; ages 2:6-7:7) or the Wechsler Intelligence Scale for Children-Fifth Edition (WISC-V; ages 6:0-16:11)

Caregiver participants must:

* Have access to a computer, tablet, or phone with a camera and Wi-Fi access

Exclusion Criteria:

* Primary concern other than anxiety as measures on the ADIS/ASA

Primary outcomes:
measure: Change in Child Anxiety Symptoms as assessed by PRAS-ASD
timeFrame: Pre to Post (~14 weeks)
measure: Change in Child Anxiety Symptoms as assessed by PRAS-ASD
timeFrame: Pre to Follow-up (~26 weeks)
measure: Change in Parent Accommodation as assessed by FAS-A
timeFrame: Pre to Post (~14 weeks)
measure: Change in Parent Accommodation as assessed by FAS-A
timeFrame: Pre to Follow-up (~26 weeks)
measure: Child Heart Rate
timeFrame: Pre to Post (~14 weeks)
measure: Parent Heart Rate
timeFrame: Pre to Post (~14 weeks)
measure: Child Respiratory Sinus Arrhythmia as assessed by Actiheart software
timeFrame: Pre to Post (~14 weeks)
measure: Parent Respiratory Sinus Arrhythmia as assessed by Actiheart software
timeFrame: Pre to Post (~14 weeks)
measure: Parent Anxiety Symptoms as assessed by GAD-7
timeFrame: Pre to Post (~14 weeks)
measure: Parent Anxiety Symptoms as assessed by GAD-7
timeFrame: Pre to Follow-up (~26 weeks)
measure: Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)
timeFrame: Pre to Post (~14 weeks)
measure: Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)
timeFrame: Pre to Follow (~26 weeks)
Secondary outcomes:
measure: Caregiver Satisfaction with treatment as assessed by Therapy Attitude Inventory (TAI)
timeFrame: Pre to Post (~14 weeks)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: