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Coaching Children With Anxiety and Autism Through Telehealth (CAT)

Primary Purpose

Autism, Autism Spectrum Disorder, Anxiety

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CAT
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism

Eligibility Criteria

48 Months - 107 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAT

Arm Description

Participants will receive behavioral treatment for anxiety.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Child Heart Rate
Change in heart rate during structured play interaction from pre to post
Parent Heart Rate
Change in heart rate during structured play interaction from pre to post
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)
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)
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 13, 2022
Last Updated
August 10, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT05588570
Brief Title
Coaching Children With Anxiety and Autism Through Telehealth
Acronym
CAT
Official Title
Coaching Children With Anxiety and Autism Through Telehealth
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 23, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum Disorder, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAT
Arm Type
Experimental
Arm Description
Participants will receive behavioral treatment for anxiety.
Intervention Type
Behavioral
Intervention Name(s)
CAT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Child Anxiety Symptoms as assessed by PRAS-ASD
Description
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.
Time Frame
Pre to Post (~14 weeks)
Title
Change in Child Anxiety Symptoms as assessed by PRAS-ASD
Description
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.
Time Frame
Pre to Follow-up (~26 weeks)
Title
Change in Parent Accommodation as assessed by FAS-A
Description
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.
Time Frame
Pre to Post (~14 weeks)
Title
Change in Parent Accommodation as assessed by FAS-A
Description
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.
Time Frame
Pre to Follow-up (~26 weeks)
Title
Child Heart Rate
Description
Change in heart rate during structured play interaction from pre to post
Time Frame
Pre to Post (~14 weeks)
Title
Parent Heart Rate
Description
Change in heart rate during structured play interaction from pre to post
Time Frame
Pre to Post (~14 weeks)
Title
Child Respiratory Sinus Arrhythmia as assessed by Actiheart software
Description
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)
Time Frame
Pre to Post (~14 weeks)
Title
Parent Respiratory Sinus Arrhythmia as assessed by Actiheart software
Description
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)
Time Frame
Pre to Post (~14 weeks)
Title
Parent Anxiety Symptoms as assessed by GAD-7
Description
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.
Time Frame
Pre to Post (~14 weeks)
Title
Parent Anxiety Symptoms as assessed by GAD-7
Description
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.
Time Frame
Pre to Follow-up (~26 weeks)
Title
Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)
Description
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.
Time Frame
Pre to Post (~14 weeks)
Title
Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)
Description
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.
Time Frame
Pre to Follow (~26 weeks)
Secondary Outcome Measure Information:
Title
Caregiver Satisfaction with treatment as assessed by Therapy Attitude Inventory (TAI)
Description
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.
Time Frame
Pre to Post (~14 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
48 Months
Maximum Age & Unit of Time
107 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Coaching Children With Anxiety and Autism Through Telehealth

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