Coaching Children With Anxiety and Autism Through Telehealth

Anxiety Clinical Trial

— CAT  

Official title:

Coaching Children With Anxiety and Autism Through Telehealth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05588570
• Other study ID #: 00121415
• Status: Completed
• Phase: N/A
• Start date: September 23, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 48 Months to 107 Months

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• CAT
Treatment includes 12 sessions: 2 caregiver teach sessions, 4 caregiver coach sessions in the child-directed interaction (CDI) phase, and 6 caregiver coach sessions in the DADS (Describe situation, Approach situation, give Direct command for child to join situation, provide Selective attention based on child's performance) phase. Throughout the 12 sessions, caregivers are coached through exposures in which the child is given the opportunity to slowly encounter anxiety-provoking factors. In the first session, caregivers are provided psychoeducation on anxiety and parenting practices and taught PRIDE (praise, reflect, imitate, describe, enjoy) skills, which are aimed at increasing approach behaviors and decreasing avoidant behaviors. In the CDI phase, caregivers are coached live via Bluetooth headset through the PRIDE and active ignoring skills. In the last 5 sessions, caregivers are coached through the DADS protocol while working up the Fear Hierarchy with the child.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Child Anxiety Symptoms as assessed by PRAS-ASD	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.	Pre to Post (~14 weeks)
Primary	Change in Child Anxiety Symptoms as assessed by PRAS-ASD	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.	Pre to Follow-up (~26 weeks)
Primary	Change in Parent Accommodation as assessed by FAS-A	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.	Pre to Post (~14 weeks)
Primary	Change in Parent Accommodation as assessed by FAS-A	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.	Pre to Follow-up (~26 weeks)
Primary	Child Heart Rate	Change in heart rate during structured play interaction from pre to post	Pre to Post (~14 weeks)
Primary	Parent Heart Rate	Change in heart rate during structured play interaction from pre to post	Pre to Post (~14 weeks)
Primary	Child Respiratory Sinus Arrhythmia as assessed by Actiheart software	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)	Pre to Post (~14 weeks)
Primary	Parent Respiratory Sinus Arrhythmia as assessed by Actiheart software	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)	Pre to Post (~14 weeks)
Primary	Parent Anxiety Symptoms as assessed by GAD-7	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.	Pre to Post (~14 weeks)
Primary	Parent Anxiety Symptoms as assessed by GAD-7	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.	Pre to Follow-up (~26 weeks)
Primary	Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)	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.	Pre to Post (~14 weeks)
Primary	Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)	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.	Pre to Follow (~26 weeks)
Secondary	Caregiver Satisfaction with treatment as assessed by Therapy Attitude Inventory (TAI)	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.	Pre to Post (~14 weeks)