Trial Outcomes & Findings for Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia (NCT NCT05822921)
NCT ID: NCT05822921
Last Updated: 2023-12-22
Results Overview
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.
COMPLETED
NA
21 participants
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)
2023-12-22
Participant Flow
The # of participants completing the study refer to child-parent pairs rather than individuals. A diagnostic evaluation for autism spectrum disorder was conducted for the child. One child did not meet ASD criteria, so that family was not assigned, leaving a final total of 20 parent-child pairs. Due to COVID-19, the protocol was revised such that participants who received either telehealth or in-person psychoeducation were grouped in a single arm (i.e., Psycho-education Clinician-led).
Participant milestones
| Measure |
Psychoeducation (PE) Clinician-led Sessions
Parents will attend two 60-minute psychoeducation sessions (either in person or via Zoom). 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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Psychoeducation (PE) Clinician-led Sessions
Parents will attend two 60-minute psychoeducation sessions (either in person or via Zoom). 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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia
Baseline characteristics by cohort
| Measure |
Psychoeducation (PE) Clinician-led Sessions
n=11 Participants
Parents will attend two 60-minute psychoeducation sessions (either in person or via Zoom). 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.
|
Psychoeducation as Usual (PAU)
n=9 Participants
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.55 years
n=5 Participants
|
34.56 years
n=7 Participants
|
34.55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Number of child-parent pairs enrolled in the study and randomized to each condition. For the PE condition, two families were in person and nine families had sessions conducted over Zoom. For the PAU condition, all families received paper materials.
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.
Outcome measures
| Measure |
Psychoeducation (PE) Clinician-led Sessions
n=11 Participants
Parents will attend two 60-minute psychoeducation sessions (either in person or via Zoom). 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.
|
Psychoeducation as Usual (PAU)
n=9 Participants
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.
|
|---|---|---|
|
Number of Parent-child Pairs Who Completed Study Sessions Assessed by Parental Attendance
Time 1: Baseline/Intake into arms (0 weeks)
|
11 parent-child pairs
|
9 parent-child pairs
|
|
Number of Parent-child Pairs Who Completed Study Sessions Assessed by Parental Attendance
Time 2: Pre-intervention (2 weeks)
|
11 parent-child pairs
|
9 parent-child pairs
|
|
Number of Parent-child Pairs Who Completed Study Sessions Assessed by Parental Attendance
Time 3: Immediately Post-intervention (4 weeks after baseline)
|
10 parent-child pairs
|
8 parent-child pairs
|
|
Number of Parent-child Pairs Who Completed Study Sessions Assessed by Parental Attendance
Time 4: 6-week follow-up (10 weeks after baseline)
|
7 parent-child pairs
|
5 parent-child pairs
|
|
Number of Parent-child Pairs Who Completed Study Sessions Assessed by Parental Attendance
Time 5: 6-month follow-up (7 months after baseline)
|
9 parent-child pairs
|
6 parent-child pairs
|
PRIMARY outcome
Timeframe: immediately post-intervention (4 weeks after baseline)Population: For the PE condition, two families were in person and nine families had sessions conducted over Zoom. For the PAU condition, all families received paper materials. One family in each condition did not complete the post-intervention measures, leaving 10 in the PE condition and 8 in the PAU condition. All measures were completed by parents in the parent-child pair. Outcome measures were not collected from children.
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.
Outcome measures
| Measure |
Psychoeducation (PE) Clinician-led Sessions
n=10 Participants
Parents will attend two 60-minute psychoeducation sessions (either in person or via Zoom). 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.
|
Psychoeducation as Usual (PAU)
n=8 Participants
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.
|
|---|---|---|
|
Parent Satisfaction Assessed Via SATISFACTION SURVEY
|
19.5 score on a scale
Interval 17.0 to 20.0
|
17.38 score on a scale
Interval 10.0 to 20.0
|
SECONDARY outcome
Timeframe: 2 weeks from start of study (pre-psychoeducation) to 4 weeks from start of study (post-psychoeducation)Population: Families who completed each arm were included in the analyses. One family in each arm did not complete the measures at post-intervention. All measures were completed by parents in the parent-child pair. Outcome measures were not collected from children.
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.
Outcome measures
| Measure |
Psychoeducation (PE) Clinician-led Sessions
n=10 Participants
Parents will attend two 60-minute psychoeducation sessions (either in person or via Zoom). 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.
|
Psychoeducation as Usual (PAU)
n=8 Participants
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.
|
|---|---|---|
|
Change in Parental Empowerment Assessed by the FAMILY EMPOWERMENT SCALE
|
7 units on a scale
Standard Deviation 8.35
|
7.88 units on a scale
Standard Deviation 18.81
|
SECONDARY outcome
Timeframe: 2 weeks from start of study (pre-psychoeducation) to 4 weeks from start of study (post-psychoeducation)Population: Families in both arms who completed psycho-education were included in analyses. One family in each arm did not complete the post-intervention measures. All measures were completed by parents in the parent-child pair. Outcome measures were not collected from children.
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.
Outcome measures
| Measure |
Psychoeducation (PE) Clinician-led Sessions
n=10 Participants
Parents will attend two 60-minute psychoeducation sessions (either in person or via Zoom). 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.
|
Psychoeducation as Usual (PAU)
n=8 Participants
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.
|
|---|---|---|
|
Change in Parental Knowledge Assessed by AUTISM STIGMA AND KNOWLEDGE QUESTIONNAIRE
|
1.4 units on a scale
Standard Deviation 1.43
|
0.5 units on a scale
Standard Deviation 2.507
|
SECONDARY outcome
Timeframe: 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)Population: Percentage of families who received any additional services from the prior time-point at any point after the psycho-education, from pre-intervention (2 weeks after baseline) up to 6 month followup (7 months after baseline). All measures were completed by parents in the parent-child pair. Outcome measures were not collected from children.
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.
Outcome measures
| Measure |
Psychoeducation (PE) Clinician-led Sessions
n=11 Participants
Parents will attend two 60-minute psychoeducation sessions (either in person or via Zoom). 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.
|
Psychoeducation as Usual (PAU)
n=9 Participants
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.
|
|---|---|---|
|
Use of Additional Autism Spectrum Disorder-related Services Assessed by NEW SERVICES SURVEY
|
81.83 percentage of families
|
55.56 percentage of families
|
Adverse Events
Psychoeducation (PE) Clinician-led Sessions
Psychoeducation as Usual (PAU)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place