AutismCATNCT05588570
Coaching Children With Anxiety and Autism Through Telehealth
A study testing CAT in people with Autism and Autism Spectrum Disorder, run by Medical University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 48 to 107 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism, Autism Spectrum Disorder, Anxiety
- What is being tested?
- CAT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 107 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Primary concern other than anxiety as measures on the ADIS/ASA
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the 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.
- Conditions
- Autism, Autism Spectrum Disorder, Anxiety
- Being tested
- CAT
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CAT | Experimental | Participants will receive behavioral treatment for anxiety. Receives: Behavioral: CAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre to Post (~14 weeks)
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.
Measured: Pre to Follow-up (~26 weeks)
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.
Measured: Pre to Post (~14 weeks)
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.
Measured: Pre to Follow-up (~26 weeks)
Child Heart Rate
Change in heart rate during structured play interaction from pre to post
Measured: Pre to Post (~14 weeks)
Parent Heart Rate
Change in heart rate during structured play interaction from pre to post
Measured: Pre to Post (~14 weeks)
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)
Measured: Pre to Post (~14 weeks)
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)
Measured: Pre to Post (~14 weeks)
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.
Measured: Pre to Post (~14 weeks)
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.
Measured: Pre to Follow-up (~26 weeks)
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.
Measured: Pre to Post (~14 weeks)
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.
Measured: Pre to Follow (~26 weeks)
Secondary outcomes (1)
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.
Measured: Pre to Post (~14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start23 Sep 2022
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Arnstein Carpenter, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588570
- Sponsor's protocol ID
- 00121415
- Acronym
- CAT
- Status last verified
- Feb 2024
- First submitted
- 13 Jun 2022
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coaching Children With Anxiety and Autism Through Telehealth
- ClinicalTrials.gov ID
- NCT05588570
- Acronym / sponsor ID
- CAT / 00121415
- Conditions
- Autism, Autism Spectrum Disorder, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAT | Experimental | Behavioral: CATParticipants will receive behavioral treatment for anxiety. |
Who may qualify
- Ages
- 48 to 107 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Primary concern other than anxiety as measures on the ADIS/ASA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CATTreatment 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. | Behavioural | CAT |
Primary outcome
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.
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.
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.
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.
Child Heart Rate
Time frame: Pre to Post (~14 weeks)
Change in heart rate during structured play interaction from pre to post
Parent Heart Rate
Time frame: Pre to Post (~14 weeks)
Change in heart rate during structured play interaction from pre to post
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)
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)
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.
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.
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.
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.
1 secondary outcome
Caregiver Satisfaction with treatment as assessed by Therapy Attitude Inventory (TAI)
Time frame: Pre to Post (~14 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAT in people with Autism and Autism Spectrum Disorder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Anxiety Symptoms as assessed by PRAS-ASD (time frame: Pre to Post (~14 weeks)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.