Coaching Children With Anxiety and Autism Through Telehealth

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder; Anxiety; Autism
• Interventions: Behavioral: CAT

• Registration Number: NCT05588570
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study First Submitted: 2022-06-13
• Study Start: 2022-09-23
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-20
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAT	CAT	Participants will receive behavioral treatment for anxiety.

Primary Outcome Measures

Name	Time	Method
Parent Heart Rate	Pre to Post (~14 weeks)	Change in heart rate during structured play interaction from pre to post
Child Heart Rate	Pre to Post (~14 weeks)	Change in heart rate during structured play interaction from pre to post
Parent Anxiety Symptoms as assessed by GAD-7	Pre to Follow-up (~26 weeks)	The Generalized Anxiety Disorder (GAD-7) is a 7-item screening tool to assess for adult anxiety. Parents score their anxiety symptoms on a 0-3 frequency scale. The GAD-7 yields a total raw score for level of anxiety and a normed T-score with higher scores indicating higher levels of anxiety. The cut-off for clinical significance is a raw score of 8.
Change in Child Anxiety Symptoms as assessed by PRAS-ASD	Pre to Follow-up (~26 weeks)	The Parent Rated Anxiety Scale for ASD (PRAS-ASD) is a 25-item measure. Parents score severity of various anxiety symptoms on a scale of 0-3. The PRAS-ASD yields a total raw score for severity of anxiety and a normed T-score with higher scores indicating higher anxiety severity. The cut-off for clinical significance is a raw score of 44.
Change in Parent Accommodation as assessed by FAS-A	Pre to Follow-up (~26 weeks)	The Family Accommodation Scale-Anxiety (FAS-A) is a 9 item measure. Parents score the amount that they accommodate their child's anxiety on a 0-4 frequency scale. The FAS-A yields a total raw score for accommodations and a normed T-score with higher scores indicating more accommodations.
Parent Respiratory Sinus Arrhythmia as assessed by Actiheart software	Pre to Post (~14 weeks)	Change in respiratory sinus arrhythmia during structured play interaction from pre to post while participant is wearing Actiheart electrodes. After heart activity is collected, Actiheart software is used to analyze Respiratory Sinus Arrhythmia (RSA)
Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)	Pre to Follow (~26 weeks)	Parents will complete the PSI-SF, a 36-item measure yielding scores for a Total Stress scale. The PSI-SF is a widely used measure in ASD samples and has been used as an outcome measure in PCIT ASD studies. The PSI-SF yields a total raw score for stress level and a percentile score which describes parent stress relative to all parents assessed during the development and testing of the PSI. Scores above 80 are considered high stress scores.
Child Respiratory Sinus Arrhythmia as assessed by Actiheart software	Pre to Post (~14 weeks)	Change in respiratory sinus arrhythmia during structured play interaction from pre to post while participant is wearing Actiheart electrodes. After heart activity is collected, Actiheart software is used to analyze Respiratory Sinus Arrhythmia (RSA)

Secondary Outcome Measures

Name	Time	Method
Caregiver Satisfaction with treatment as assessed by Therapy Attitude Inventory (TAI)	Pre to Post (~14 weeks)	To assess treatment satisfaction, parents will complete the TAI, which is widely used in PCIT studies. Several questions will be added to the TAI to address parental satisfaction and openness regarding the telehealth delivery format for families in the Tele-PCIT condition. The TAI uses a Likert-type satisfaction scale and scores will be reported via descriptive statistics with 95% CIs within categories.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States