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Completed

NCT Number: NCT05588570

Coaching Children With Anxiety and Autism Through Telehealth

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.

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Key information

Conditions

Autism Anxiety Anxiety Disorders Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

48 month–107 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAT

Behavioral

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 outcomes

  1. Change in Child Anxiety Symptoms as assessed by PRAS-ASD

    Time frame: Pre to Post (~14 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.

  2. Change in Child Anxiety Symptoms as assessed by PRAS-ASD

    Time frame: 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.

  3. Change in Parent Accommodation as assessed by FAS-A

    Time frame: Pre to Post (~14 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.

  4. Change in Parent Accommodation as assessed by FAS-A

    Time frame: 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.

  5. Child Heart Rate

    Time frame: Pre to Post (~14 weeks)

    Change in heart rate during structured play interaction from pre to post

  6. Parent Heart Rate

    Time frame: Pre to Post (~14 weeks)

    Change in heart rate during structured play interaction from pre to post

  7. Child Respiratory Sinus Arrhythmia as assessed by Actiheart software

    Time frame: 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)

  8. Parent Respiratory Sinus Arrhythmia as assessed by Actiheart software

    Time frame: 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)

  9. Parent Anxiety Symptoms as assessed by GAD-7

    Time frame: Pre to Post (~14 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.

  10. Parent Anxiety Symptoms as assessed by GAD-7

    Time frame: 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.

  11. Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)

    Time frame: Pre to Post (~14 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.

  12. Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)

    Time frame: 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.

Secondary outcomes

  1. Caregiver Satisfaction with treatment as assessed by Therapy Attitude Inventory (TAI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Acronym: CAT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 20, 2022
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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