Autism Spectrum DisorderNCT05822921
Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia
A study testing In-person Psychoeducation (IP), Telehealth Psychoeducation (TH) and Psychoeducation as Usual (PAU) in people with Autism Spectrum Disorder, run by Virginia Polytechnic Institute and State University at 2 sites in United States.
Trial summary
This study will be the pilot/feasibility phase of a future clinical trial. The proposed feasibility and pilot study aims to bridge the barriers to diagnosis by providing easy-to-access assessment for free, through a mobile unit that travels to rural locations and telehealth assessments. Read more about this study
- Who is it for?
- Ages 16 months to 17 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- In-person Psychoeducation (IP), Telehealth Psychoeducation (TH) and Psychoeducation as Usual (PAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jul 2019to 12 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent(s)/Caregiver(s) to a child between the ages of 16 months through 17 years old with autism concern, who are seeking a diagnostic assessment, and live in a rural underserved community
- Recruitment in line with gender ratio seen in the prevalence of ASD (i.e., 4.2 boys to 1 girl)
- English-speaking parent
- Added April 2020: For the second half of the study (Tele-assessment), parents must have a computer, laptop, or tablet (at least 9.7 inches diagonally) with web-camera and stable Internet.
Who cannot join
- Children participants who will turn 18 before their participation in the study has ended
- If a family does not have Internet and computer access, the family will not be excluded, but will be randomized into a group other than the telehealth psychoeducation group.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Virginia Tech
Blacksburg, Virginia, 24060
Mount Rogers Community Services
Wytheville, Virginia, 24382
About this study
This study will be the pilot/feasibility phase of a future clinical trial. The proposed feasibility and pilot study aims to bridge the barriers to diagnosis by providing easy-to-access assessment for free, through a mobile unit that travels to rural locations and telehealth assessments. The diagnostic evaluation will confirm or rule out a diagnosis of ASD, followed by purposeful ASD psychoeducation for parents whose children are diagnosed.
Parents of children who meet criteria for a diagnosis of autism spectrum disorder (ASD) or are suspected to have ASD will be randomized into one of three groups (i.e., in-person psychoeducation, telehealth psychoeducation, or "psychoeducation as usual" with paper psychoeducation materials). Parents will complete outcome measures related to their satisfaction, empowerment, and autism spectrum disorder knowledge. Changes in empowerment and ASD knowledge from pre- to post- psychoeducation will be measured using t-tests. The investigators will also track if participants sought and/or received additional ASD-related services throughout the study up to 6-months post-psychoeducation. Results from this study will help to guide a future, fully powered efficacy trial with a larger sample.
Added April 2020: In light of the Virginia governor's stay-at-home order in response to the COVID-19 outbreak, the investigators are altering the protocol in line with the university's request to move to remote conduct of research where possible as well as to continue to provide services to families in this time, in line with Executive Order 53 from the VA Governor. Parents in the latter half of the study conducted entirely remotely, will be randomized into the two psychoeducation conditions, telehealth or paper materials psychoeducation groups, as in-person visits are not permitted. Statistical analyses will be added to compare results between and within those who received in-person versus telehealth assessments. The investigators and participants may return to in-person assessments if and when it is possible to do so, but reserve the right to continue tele-assessment even once stay-at-home orders are lifted, in order to fully answer the research aim of the feasibility and validity or tele-assessment procedures in ASD.
Read the detailed description
This study will be the pilot/feasibility phase of a future clinical trial. The proposed feasibility and pilot study aims to bridge the barriers to diagnosis by providing easy-to-access assessment for free, through a mobile unit that travels to rural locations and telehealth assessments. The diagnostic evaluation will confirm or rule out a diagnosis of ASD, followed by purposeful ASD psychoeducation for parents whose children are diagnosed.
Parents of children who meet criteria for a diagnosis of autism spectrum disorder (ASD) or are suspected to have ASD will be randomized into one of three groups (i.e., in-person psychoeducation, telehealth psychoeducation, or "psychoeducation as usual" with paper psychoeducation materials). Parents will complete outcome measures related to their satisfaction, empowerment, and autism spectrum disorder knowledge. Changes in empowerment and ASD knowledge from pre- to post-psychoeducation will be measured using t-tests. The investigators will also track if participants sought and/or received additional ASD-related services throughout the study, up to 6-months post-psychoeducation. Results from this study will help to guide a future, fully powered efficacy trial with a larger sample.
Added April 2020:
In light of the Virginia governor's stay-at-home order in response to the COVID-19 outbreak, which reached pandemic status approximately halfway through data collection, all in-person research and clinical services have been paused at Virginia Tech as of March 13, 2020. To continue to provide services to families in this time, in line with Executive Order 53 from the VA Governor to ensure that the stay-at-home orders do not limit the provision of health care or medical services, this study will begin exploring the feasibility of conducting tele-assessment, a comprehensive assessment battery via a secure video platform and phone.
As such, the protocol is altered to be in line with the university's request to move to remote conduct of research where possible. For the remaining half of participants, the investigators will replace the mobile assessment battery with a tele-assessment battery, delivered via secure online video platform ZoomHIPAA and/or by phone (totaling up to 7 hours of assessment). As such, the protocol is revised to include tele-assessments (no in-person assessments) and randomly assigning eligible participants to either the telehealth or paper materials psychoeducation groups. All outcome measures will remain the same, but will be collected online or by telephone. The investigators and participants may return to in-person assessments if and when it is possible, but reserve the right to continue tele-assessment even once stay-at-home orders are lifted.
The aims of the project will be altered somewhat by the updated procedure. The study will be significantly underpowered to analyze the differences between psychoeducation conditions within and between each assessment modality (i.e., in-person vs. telehealth), therefore in person and telehealth conditions will be combined into one psychoeducation (PE) group with clinician-led sessions. The mean differences between the PE group and the psychoeducation as usual (i.e., paper materials) formats will be preliminarily explored, in terms of both feasibility and satisfaction of the psychoeducation services and changes in outcome measures (i.e., FES and ASK-Q). Pending permission to return to in-person assessments, analyses will also report alignment between diagnoses made via tele-assessment (CARS-2 and ADI-R) and a later in-person administration of the ADOS-2.
- Conditions
- Autism Spectrum Disorder
- Being tested
- In-person Psychoeducation (IP), Telehealth Psychoeducation (TH), Psychoeducation as Usual (PAU)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person Psychoeducation (IP)Behavioural
Parents will attend two 60-minute (i.e. one day per week, for the next two weeks), in-person psychoeducation sessions on the MAC, in or near their hometown. During these sessions, a clinician will discuss a series of psychoeducation topics supplemented with PowerPoint slides. Across the two sessions, the following topics will be covered: (1) signs/symptoms and epidemiology of ASD, (2) risk factors associated with developing ASD (e.g., genetics, neurobiology, environment, social motivation), (3) navigating the IEP process, and (4) evidence-based best practices recommended for their child's profile of ASD symptoms and co-occurring conditions. This delivery method will allow parents to ask questions and receive immediate, live, and detailed answers from an expert clinician, to focus on specific examples relevant to their child, and to foster ASD knowledge and efficacy in helping their child.
Telehealth Psychoeducation (TH)Behavioural
Parents in this group will attend two 60-minute sessions, remotely via a live video chat platform, rather than in-person. Otherwise, it will follow the same format and PowerPoint materials as the IP Group. Sessions will still be facilitated by a clinician, thus maintaining the option to ask questions, discuss personalized examples, etc. For families without computer and internet access, the family will be assisted with to connecting to internet access at a private and convenient location (e.g., a church, library, or local community services agency). In the event that this is not possible, the family will be randomized to one of the other two groups.
Psychoeducation as Usual (PAU)Behavioural
Parents in this group will receive basic paper psychoeducation resources, distributed at their feedback session. It will be up to each parent how frequently and diligently these resources are reviewed. This should be akin to what a family might have access to at their pediatric or primary care office. To be consistent across study groups, the materials produced for these parents will be comprehensive and will include the same span of content as the PowerPoint slides used in the other two groups, but without structured sessions facilitated by a clinician. Upon distribution of materials, parents will be provided with our contact information and encouraged to reach out if any questions occur. Parents in the paper informational materials group will have the option to complete two in-person or video conference psychoeducation sessions after the end of the study, if preferred (i.e., 6 months later).
| Study group | Role | What they receive |
|---|---|---|
| In-person Psychoeducation | Experimental | Not described Receives: Behavioral: In-person Psychoeducation (IP) |
| Telehealth Psychoeducation | Experimental | Not described Receives: Behavioral: Telehealth Psychoeducation (TH) |
| Psychoeducation as Usual | Active comparator | Not described Receives: Behavioral: Psychoeducation as Usual (PAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Parent-child Pairs Who Completed Study Sessions Assessed by Parental Attendance
Retention of participants assessed by parental attendance for all study sessions. Only parental attendance to psycho-education sessions was included for this measure. Child attendance was not needed.
Measured: Time 1: Baseline/intake (0 weeks); Time 2: Pre-intervention (2 weeks); Time 3: Immediately post-intervention (4 weeks after baseline); Time 4: 6- week followup (10 weeks after baseline); Time 5: 6-month followup (7 months after baseline)
Parent Satisfaction Assessed Via SATISFACTION SURVEY
SATISFACTION SURVEY: A satisfaction survey will be administered to elicit parents' feedback on our service.Satisfaction survey administered immediately post-psychoeducation, on a scale of 0=completely disagree to 4= completely agree with statements about satisfaction with psychoeducation received, ability to function day to day, learning throughout materials, ability to handle situations with child in future, and ability to gain a better outlook on life with child. Total sum scores were used, for a range of 0 to 20, with higher scores indicating greater satisfaction.
Measured: immediately post-intervention (4 weeks after baseline)
Secondary outcomes (3)
Change in Parental Empowerment Assessed by the FAMILY EMPOWERMENT SCALE
Parental empowerment will be assessed by the Family Empowerment Scale and compared across education delivery formats. The Family Empowerment Scale measures levels of perceived efficacy in community involvement, navigating services for child and family. This scale includes three areas (family domain, service system domain, and community/political domain). Range of scores per domain include: family domain (12 to 60), service system domain (12 to 60), and community/political domain (10 to 50). Total sum scores could range from 34 - 170. A higher score indicates greater empowerment in a given domain. Change in sum total score across all domains from pre- to post-psychoeducation was used for analysis.
Measured: 2 weeks from start of study (pre-psychoeducation) to 4 weeks from start of study (post-psychoeducation)
Change in Parental Knowledge Assessed by AUTISM STIGMA AND KNOWLEDGE QUESTIONNAIRE
Parental knowledge will be assessed using the AUTISM STIGMA AND KNOWLEDGE QUESTIONNAIRE. Total sum scores range from minimum score = 0 to maximum score = 48. A higher raw score is better and indicates more autism knowledge and less autism stigma. Change score from pre- to post- psychoeducation was used for analysis.
Measured: 2 weeks from start of study (pre-psychoeducation) to 4 weeks from start of study (post-psychoeducation)
Use of Additional Autism Spectrum Disorder-related Services Assessed by NEW SERVICES SURVEY
Use of additional Autism Spectrum Disorder-related services accessed will be assessed using a NEW SERVICES SURVEY. Parents will be surveyed as to what new services have been used since the last session or survey time point. This survey will ask whether parents have contacted other service agencies, the date of contact, whether they received any new services (and to specify the services received), and the date of first service received.
Measured: Time 2: pre-intervention (2 weeks after baseline), Time 3: immediately post-intervention (4 weeks after baseline), Time 4: 6-week followup (10 weeks after baseline), to Time 5: 6-month followup (7 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start17 Jul 2019
- Primary completion1 Sep 2020
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parents of children who meet criteria for a diagnosis of autism spectrum disorder (ASD) will be randomized into one of three groups (i.e., in-person psychoeducation, telehealth psychoeducation, or "psychoeducation as usual" with paper psychoeducation materials).
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Speaks, University of Virginia, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Angela Scarpa, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822921
- Sponsor's protocol ID
- 19-423
- Other IDs
- UL1TR003015
- Status last verified
- Oct 2023
- First submitted
- 1 Feb 2023
- Last updated
- 22 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia
- ClinicalTrials.gov ID
- NCT05822921
- Acronym / sponsor ID
- 19-423
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- Autism Speaks, University of Virginia, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Posted 22 Dec 2023
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 be the pilot/feasibility phase of a future clinical trial. The proposed feasibility and pilot study aims to bridge the barriers to diagnosis by providing easy-to-access assessment for free, through a mobile unit that travels to rural locations and telehealth assessments. The diagnostic evaluation will confirm or rule out a diagnosis of ASD, followed by purposeful ASD psychoeducation for parents whose children are diagnosed.
Parents of children who meet criteria for a diagnosis of autism spectrum disorder (ASD) or are suspected to have ASD will be randomized into one of three groups (i.e., in-person psychoeducation, telehealth psychoeducation, or "psychoeducation as usual" with paper psychoeducation materials). Parents will complete outcome measures related to their satisfaction, empowerment, and autism spectrum disorder knowledge. Changes in empowerment and ASD knowledge from pre- to post- psychoeducation will be measured using t-tests. The investigators will also track if participants sought and/or received additional ASD-related services throughout the study up to 6-months post-psychoeducation. Results from this study will help to guide a future, fully powered efficacy trial with a larger sample.
Added April 2020: In light of the Virginia governor's stay-at-home order in response to the COVID-19 outbreak, the investigators are altering the protocol in line with the university's request to move to remote conduct of research where possible as well as to continue to provide services to families in this time, in line with Executive Order 53 from the VA Governor. Parents in the latter half of the study conducted entirely remotely, will be randomized into the two psychoeducation conditions, telehealth or paper materials psychoeducation groups, as in-person visits are not permitted. Statistical analyses will be added to compare results between and within those who received in-person versus telehealth assessments. The investigators and participants may return to in-person assessments if and when it is possible to do so, but reserve the right to continue tele-assessment even once stay-at-home orders are lifted, in order to fully answer the research aim of the feasibility and validity or tele-assessment procedures in ASD.
Detailed description
This study will be the pilot/feasibility phase of a future clinical trial. The proposed feasibility and pilot study aims to bridge the barriers to diagnosis by providing easy-to-access assessment for free, through a mobile unit that travels to rural locations and telehealth assessments. The diagnostic evaluation will confirm or rule out a diagnosis of ASD, followed by purposeful ASD psychoeducation for parents whose children are diagnosed.
Parents of children who meet criteria for a diagnosis of autism spectrum disorder (ASD) or are suspected to have ASD will be randomized into one of three groups (i.e., in-person psychoeducation, telehealth psychoeducation, or "psychoeducation as usual" with paper psychoeducation materials). Parents will complete outcome measures related to their satisfaction, empowerment, and autism spectrum disorder knowledge. Changes in empowerment and ASD knowledge from pre- to post-psychoeducation will be measured using t-tests. The investigators will also track if participants sought and/or received additional ASD-related services throughout the study, up to 6-months post-psychoeducation. Results from this study will help to guide a future, fully powered efficacy trial with a larger sample.
Added April 2020:
In light of the Virginia governor's stay-at-home order in response to the COVID-19 outbreak, which reached pandemic status approximately halfway through data collection, all in-person research and clinical services have been paused at Virginia Tech as of March 13, 2020. To continue to provide services to families in this time, in line with Executive Order 53 from the VA Governor to ensure that the stay-at-home orders do not limit the provision of health care or medical services, this study will begin exploring the feasibility of conducting tele-assessment, a comprehensive assessment battery via a secure video platform and phone.
As such, the protocol is altered to be in line with the university's request to move to remote conduct of research where possible. For the remaining half of participants, the investigators will replace the mobile assessment battery with a tele-assessment battery, delivered via secure online video platform ZoomHIPAA and/or by phone (totaling up to 7 hours of assessment). As such, the protocol is revised to include tele-assessments (no in-person assessments) and randomly assigning eligible participants to either the telehealth or paper materials psychoeducation groups. All outcome measures will remain the same, but will be collected online or by telephone. The investigators and participants may return to in-person assessments if and when it is possible, but reserve the right to continue tele-assessment even once stay-at-home orders are lifted.
The aims of the project will be altered somewhat by the updated procedure. The study will be significantly underpowered to analyze the differences between psychoeducation conditions within and between each assessment modality (i.e., in-person vs. telehealth), therefore in person and telehealth conditions will be combined into one psychoeducation (PE) group with clinician-led sessions. The mean differences between the PE group and the psychoeducation as usual (i.e., paper materials) formats will be preliminarily explored, in terms of both feasibility and satisfaction of the psychoeducation services and changes in outcome measures (i.e., FES and ASK-Q). Pending permission to return to in-person assessments, analyses will also report alignment between diagnoses made via tele-assessment (CARS-2 and ADI-R) and a later in-person administration of the ADOS-2.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parents of children who meet criteria for a diagnosis of autism spectrum disorder (ASD) will be randomized into one of three groups (i.e., in-person psychoeducation, telehealth psychoeducation, or "psychoeducation as usual" with paper psychoeducation materials).
| Arm | Type | Receives |
|---|---|---|
| In-person Psychoeducation | Experimental | Behavioral: In-person Psychoeducation (IP) |
| Telehealth Psychoeducation | Experimental | Behavioral: Telehealth Psychoeducation (TH) |
| Psychoeducation as Usual | Active comparator | Behavioral: Psychoeducation as Usual (PAU) |
Who may qualify
- Ages
- 16 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parent(s)/Caregiver(s) to a child between the ages of 16 months through 17 years old with autism concern, who are seeking a diagnostic assessment, and live in a rural underserved community
- Recruitment in line with gender ratio seen in the prevalence of ASD (i.e., 4.2 boys to 1 girl)
- English-speaking parent
- Added April 2020: For the second half of the study (Tele-assessment), parents must have a computer, laptop, or tablet (at least 9.7 inches diagonally) with web-camera and stable Internet.
Key exclusion criteria (2 listed)
- Children participants who will turn 18 before their participation in the study has ended
- If a family does not have Internet and computer access, the family will not be excluded, but will be randomized into a group other than the telehealth psychoeducation group.
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 |
|---|---|---|
| In-person Psychoeducation (IP)Parents will attend two 60-minute (i.e. one day per week, for the next two weeks), in-person psychoeducation sessions on the MAC, in or near their hometown. During these sessions, a clinician will discuss a series of psychoeducation topics supplemented with PowerPoint slides. Across the two sessions, the following topics will be covered: (1) signs/symptoms and epidemiology of ASD, (2) risk factors associated with developing ASD (e.g., genetics, neurobiology, environment, social motivation), (3) navigating the IEP process, and (4) evidence-based best practices recommended for their child's profile of ASD symptoms and co-occurring conditions. This delivery method will allow parents to ask questions and receive immediate, live, and detailed answers from an expert clinician, to focus on specific examples relevant to their child, and to foster ASD knowledge and efficacy in helping their child. | Behavioural | In-person Psychoeducation |
| Telehealth Psychoeducation (TH)Parents in this group will attend two 60-minute sessions, remotely via a live video chat platform, rather than in-person. Otherwise, it will follow the same format and PowerPoint materials as the IP Group. Sessions will still be facilitated by a clinician, thus maintaining the option to ask questions, discuss personalized examples, etc. For families without computer and internet access, the family will be assisted with to connecting to internet access at a private and convenient location (e.g., a church, library, or local community services agency). In the event that this is not possible, the family will be randomized to one of the other two groups. | Behavioural | Telehealth Psychoeducation |
| Psychoeducation as Usual (PAU)Parents in this group will receive basic paper psychoeducation resources, distributed at their feedback session. It will be up to each parent how frequently and diligently these resources are reviewed. This should be akin to what a family might have access to at their pediatric or primary care office. To be consistent across study groups, the materials produced for these parents will be comprehensive and will include the same span of content as the PowerPoint slides used in the other two groups, but without structured sessions facilitated by a clinician. Upon distribution of materials, parents will be provided with our contact information and encouraged to reach out if any questions occur. Parents in the paper informational materials group will have the option to complete two in-person or video conference psychoeducation sessions after the end of the study, if preferred (i.e., 6 months later). | Behavioural | Psychoeducation as Usual |
Primary outcome
Number of Parent-child Pairs Who Completed Study Sessions Assessed by Parental Attendance
Time frame: Time 1: Baseline/intake (0 weeks); Time 2: Pre-intervention (2 weeks); Time 3: Immediately post-intervention (4 weeks after baseline); Time 4: 6- week followup (10 weeks after baseline); Time 5: 6-month followup (7 months after baseline)
Retention of participants assessed by parental attendance for all study sessions. Only parental attendance to psycho-education sessions was included for this measure. Child attendance was not needed.
Parent Satisfaction Assessed Via SATISFACTION SURVEY
Time frame: immediately post-intervention (4 weeks after baseline)
SATISFACTION SURVEY: A satisfaction survey will be administered to elicit parents' feedback on our service.Satisfaction survey administered immediately post-psychoeducation, on a scale of 0=completely disagree to 4= completely agree with statements about satisfaction with psychoeducation received, ability to function day to day, learning throughout materials, ability to handle situations with child in future, and ability to gain a better outlook on life with child. Total sum scores were used, for a range of 0 to 20, with higher scores indicating greater satisfaction.
3 secondary outcomes
Change in Parental Empowerment Assessed by the FAMILY EMPOWERMENT SCALE
Time frame: 2 weeks from start of study (pre-psychoeducation) to 4 weeks from start of study (post-psychoeducation)
Change in Parental Knowledge Assessed by AUTISM STIGMA AND KNOWLEDGE QUESTIONNAIRE
Time frame: 2 weeks from start of study (pre-psychoeducation) to 4 weeks from start of study (post-psychoeducation)
Use of Additional Autism Spectrum Disorder-related Services Assessed by NEW SERVICES SURVEY
Time frame: Time 2: pre-intervention (2 weeks after baseline), Time 3: immediately post-intervention (4 weeks after baseline), Time 4: 6-week followup (10 weeks after baseline), to Time 5: 6-month followup (7 months after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Angela Scarpa, PhD principal investigator
Virginia Polytechnic Institute and State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person Psychoeducation (IP), Telehealth Psychoeducation (TH) and Psychoeducation as Usual (PAU) in people with Autism Spectrum Disorder, run by Virginia Polytechnic Institute and State University at 2 sites 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 4 inclusion and 2 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 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 22 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Parent-child Pairs Who Completed Study Sessions Assessed by Parental Attendance (time frame: Time 1: Baseline/intake (0 weeks); Time 2: Pre-intervention (2 weeks); Time 3: Immediately post-intervention (4 weeks after baseline); Time 4: 6- week followup (10 weeks after baseline); Time 5: 6-month followup (7 months after baseline)). The study lists 2 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 22 Dec 2023.