Autism Spectrum DisorderNCT04931043
Feasibility of Competent Learner Model With Families of Children With ASD
An observational study of Autism Spectrum Disorder, run by West Virginia University at 1 site in United States.
Trial summary
Autism Spectrum Disorder (ASD) is a lifelong, neurodevelopmental disorder effecting one in fifty-nine children. Each individual with ASD is unique. Children with ASD may have trouble making friends, keeping friends, communicating their needs, engaging in leisure activities, learning to read and do math, and many other… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2018to 12 Jun 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Families were recruited through healthcare offices including primary care and behavioral health offices.
Inclusion Criteria: Caregiver-child dyads were eligible to participate if:
- the child has a diagnosis of Autism
- the child was under 18-years-old
- the child's legal guardian consented to treatment
- the child's insurance was accepted at this clinic or the family will pay for the services
Exclusion Criteria: Children were excluded from the study if:
- they were currently receiving intensive applied behavior analysis in the home
- the caregiver would not consent to being videotaped.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Medicine University Behavioral Medicine and Psychiatry
Martinsburg, West Virginia, 25401
About this study
Official title: Feasibility of Parent Training Using the Competent Learner Model With Families of Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD) is a lifelong, neurodevelopmental disorder effecting one in fifty-nine children. Each individual with ASD is unique. Children with ASD may have trouble making friends, keeping friends, communicating their needs, engaging in leisure activities, learning to read and do math, and many other challenges. The children may engage in repetitive behaviors such as hitting themselves or flapping their hands, and may be over sensitive to particular sounds or lights which can make certain places, such as a store, very uncomfortable. Also, children with ASD may have challenging behaviors such as hitting others and excessive tantrums that can seem uncontrollable. 25 to 40 hours a week of intensive applied behavior analysis is the evidence-based treatment for children with ASD. Many children with ASD in rural areas and certain states are unable to access evidence-based treatment because of insurance barriers and lack of providers. The Competent Learner Model uses strategies from applied behavior analysis to target core skills that increase successful participation in life activities. Its program is applicable across all ages and developmental levels, and it has an online course of study which has been used to train professionals and lay people alike including parents. The purpose of this study was to assess the feasibility of training parents in applied behavior analysis using the Competent Learner Model with children with ASD who do not have access to treatment. The program consisted of a hybrid of group sessions for caregivers, coaching sessions for the caregiver-child dyads, and online units for caregivers. This project assessed participation in and satisfaction with the program as well as changes in parenting stress. Feedback from caregivers will be used to create a more satisfactory method of increasing accessing to families of children with Autism Spectrum Disorder in rural areas.
Read the detailed description
Specific Aims: Many children with Autism in West Virginia are not able to access the evidence-based treatment, intensive applied behavior analysis, because of insurance barriers and lack of providers. Training parents in applied behavior analysis using the Competent Learner Model may allow children to access treatment. The purpose of this study was to determine if it is feasible to use online training units, group sessions for caregivers co-led by a parent, and family coaching sessions to improve the functioning of children with Autism. The current study is the first examination of Competent Learner Model as an independent intervention for parents using a hybrid of group and family sessions. Hypotheses: (1) Parent will complete therapy homework and attend 90% of sessions. (2) Parents will report a decrease in parenting stress.
Background: Autism is a lifelong, developmental disorder that affects 1 in 59 children, which represents about 720 children in the region of West Virginia where this study took place. Challenges for children with Autism include difficulty making and keeping friends, trouble talking to people, and insisting on rigid routines that interfere with daily life. The children may have challenging behavior such as hitting themselves, hitting others, and extreme meltdowns. Children may struggle to learn in typical classrooms, and may have trouble going to community events with their families. Families participate in fewer community activities leading to social isolation, and parents of children with Autism are more stressed than other parents. 25-40 hours per week of applied behavior analysis for 1-3 years is the evidence-based treatment for Autism. Many insurance companies in West Virginia specifically exclude services for children with Autism, and the Mountaineer Autism Project has estimated that only 1.6% of children with Autism in the state are receiving applied behavior analysis. Additionally, West Virginia has a limited number of providers for Autism. Children with Autism make greater progress across multiple settings (e.g., home, public) when their caregivers are involved in treatment, and coaching results in greater improvements in child behavior following behavioral parent training. Parent-implemented interventions for Autism are promising but more research is needed. When parents are trained to use the therapeutic strategies, the parent may be able to increase the child's skill development (e.g., self-care, functional academics, and social skills) across multiple settings and feel less stressed. The Competent Learner Model uses concepts and strategies from applied behavior analysis, Direct Instruction, and Precision Teaching to improve functioning of individuals with Autism. The program targets core skills that facilitate successful participation across all areas of an individuals' life, and it can be applied across all ages and developmental levels. A core component of the Competent Learner Model is the Course of Study, which has been used to train professionals and lay people. The Course of Study is a sequence of online training units using programmed instruction formats with embedded active student responding, video examples, and skill check outs. Coaching is a critical component of the program. While the Competent Learner Model uses well-researched strategies, the research of the program's effectiveness consists primarily of poster presentations and a handful of dissertations. One study found parents were better able to apply strategies and reported less stress when the parents were trained supplemental to their child's treatment. The effectiveness of the Competent Learner Model as implemented by parents independent of other treatment is unknown. Parent training using the Competent Learner Model may provide access to effective treatment for families. If this program is effective in training parents, it will increase access to effective services, decrease the amount of face-to-face time a parent must spend with a clinician and, thus, allow the clinician to serve a greater number of families simultaneously. More broadly, this treatment approach may present a treatment option for rural Americans with limited access to behavioral health outside of West Virginia as well. The study will contribute to the literature of training parents as therapists for their children with Autism.
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Parent Training, Applied Behavior Analysis, Rural
- Medical subject headings
- Autism Spectrum Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Session Attendance
Number of sessions attended divided by total session
Measured: Up to 16 weeks
Homework Completion
Number of training units completed in entirety divided by total units
Measured: Up to 16 weeks
Secondary outcomes (2)
Parenting Stress Index Fourth Edition
36-item parent report questionnaire assessing stress in parent-child relationships, dysfunctional parenting, and child adjustment problems
Measured: From baseline to post intervention, up to 4 months
Parent Sense of Competence Scale
Parent-report questionnaire assessing parenting attitudes and behaviors
Measured: From baseline to post intervention, up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start26 Nov 2018
- Primary completion12 Jun 2019
- Study completion12 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocelyn Stokes, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931043
- Sponsor's protocol ID
- 1803052856
- Status last verified
- Jun 2021
- First submitted
- 29 Apr 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Researchers may share data from the current study based on individual request from the other researcher
Publications
Smith T, Iadarola S. Evidence Base Update for Autism Spectrum Disorder. J Clin Child Adolesc Psychol. 2015;44(6):897-922. doi: 10.1080/15374416.2015.1077448.
PubMed 26430947Kaminski JW, Valle LA, Filene JH, Boyle CL. A meta-analytic review of components associated with parent training program effectiveness. J Abnorm Child Psychol. 2008 May;36(4):567-89. doi: 10.1007/s10802-007-9201-9. Epub 2008 Jan 19.
PubMed 18205039McConachie H, Diggle T. Parent implemented early intervention for young children with autism spectrum disorder: a systematic review. J Eval Clin Pract. 2007 Feb;13(1):120-9. doi: 10.1111/j.1365-2753.2006.00674.x.
PubMed 17286734Stokes TF, Baer DM. An implicit technology of generalization. J Appl Behav Anal. 1977 Summer;10(2):349-67. doi: 10.1901/jaba.1977.10-349.
PubMed 16795561Baio J, Wiggins L, Christensen DL, Maenner MJ, Daniels J, Warren Z, Kurzius-Spencer M, Zahorodny W, Robinson Rosenberg C, White T, Durkin MS, Imm P, Nikolaou L, Yeargin-Allsopp M, Lee LC, Harrington R, Lopez M, Fitzgerald RT, Hewitt A, Pettygrove S, Constantino JN, Vehorn A, Shenouda J, Hall-Lande J, Van Naarden Braun K, Dowling NF. Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2014. MMWR Surveill Summ. 2018 Apr 27;67(6):1-23. doi: 10.15585/mmwr.ss6706a1.
PubMed 29701730Mancil G. R., Boyd, B. A., & Bedersem, P. Parental stress and autism: Are there useful coping strategies? Education and Training in Developmental Disabilities. 2009; 44:4; 523-537.
Burrell, T. L., & Borrego, J. Parents' involvement in ASD treatment: What is their role? Cognitive and Behavioral Practice. 2012; 19(3): 423-432.
Tucci, V., Hursh, D., Laitinen, R., & Lambe, A. Competent learner model for individuals with autism/ PDD. Exceptionality. 2005; 13(1); 55-63.
Lofton, K. L. Autism services lacking for West Virginia families. Appalachia Health News. April 6, 2016. wvpublic.org/post/autism-services-lacking-west-virginia-families. Accessed March 5, 2018.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Parent Training Using the Competent Learner Model With Families of Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04931043
- Acronym / sponsor ID
- 1803052856
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Parent Training, Applied Behavior Analysis, Rural
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 18 Jun 2021 (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.
Autism Spectrum Disorder (ASD) is a lifelong, neurodevelopmental disorder effecting one in fifty-nine children. Each individual with ASD is unique. Children with ASD may have trouble making friends, keeping friends, communicating their needs, engaging in leisure activities, learning to read and do math, and many other challenges. The children may engage in repetitive behaviors such as hitting themselves or flapping their hands, and may be over sensitive to particular sounds or lights which can make certain places, such as a store, very uncomfortable. Also, children with ASD may have challenging behaviors such as hitting others and excessive tantrums that can seem uncontrollable. 25 to 40 hours a week of intensive applied behavior analysis is the evidence-based treatment for children with ASD. Many children with ASD in rural areas and certain states are unable to access evidence-based treatment because of insurance barriers and lack of providers. The Competent Learner Model uses strategies from applied behavior analysis to target core skills that increase successful participation in life activities. Its program is applicable across all ages and developmental levels, and it has an online course of study which has been used to train professionals and lay people alike including parents. The purpose of this study was to assess the feasibility of training parents in applied behavior analysis using the Competent Learner Model with children with ASD who do not have access to treatment. The program consisted of a hybrid of group sessions for caregivers, coaching sessions for the caregiver-child dyads, and online units for caregivers. This project assessed participation in and satisfaction with the program as well as changes in parenting stress. Feedback from caregivers will be used to create a more satisfactory method of increasing accessing to families of children with Autism Spectrum Disorder in rural areas.
Detailed description
Specific Aims: Many children with Autism in West Virginia are not able to access the evidence-based treatment, intensive applied behavior analysis, because of insurance barriers and lack of providers. Training parents in applied behavior analysis using the Competent Learner Model may allow children to access treatment. The purpose of this study was to determine if it is feasible to use online training units, group sessions for caregivers co-led by a parent, and family coaching sessions to improve the functioning of children with Autism. The current study is the first examination of Competent Learner Model as an independent intervention for parents using a hybrid of group and family sessions. Hypotheses: (1) Parent will complete therapy homework and attend 90% of sessions. (2) Parents will report a decrease in parenting stress.
Background: Autism is a lifelong, developmental disorder that affects 1 in 59 children, which represents about 720 children in the region of West Virginia where this study took place. Challenges for children with Autism include difficulty making and keeping friends, trouble talking to people, and insisting on rigid routines that interfere with daily life. The children may have challenging behavior such as hitting themselves, hitting others, and extreme meltdowns. Children may struggle to learn in typical classrooms, and may have trouble going to community events with their families. Families participate in fewer community activities leading to social isolation, and parents of children with Autism are more stressed than other parents. 25-40 hours per week of applied behavior analysis for 1-3 years is the evidence-based treatment for Autism. Many insurance companies in West Virginia specifically exclude services for children with Autism, and the Mountaineer Autism Project has estimated that only 1.6% of children with Autism in the state are receiving applied behavior analysis. Additionally, West Virginia has a limited number of providers for Autism. Children with Autism make greater progress across multiple settings (e.g., home, public) when their caregivers are involved in treatment, and coaching results in greater improvements in child behavior following behavioral parent training. Parent-implemented interventions for Autism are promising but more research is needed. When parents are trained to use the therapeutic strategies, the parent may be able to increase the child's skill development (e.g., self-care, functional academics, and social skills) across multiple settings and feel less stressed. The Competent Learner Model uses concepts and strategies from applied behavior analysis, Direct Instruction, and Precision Teaching to improve functioning of individuals with Autism. The program targets core skills that facilitate successful participation across all areas of an individuals' life, and it can be applied across all ages and developmental levels. A core component of the Competent Learner Model is the Course of Study, which has been used to train professionals and lay people. The Course of Study is a sequence of online training units using programmed instruction formats with embedded active student responding, video examples, and skill check outs. Coaching is a critical component of the program. While the Competent Learner Model uses well-researched strategies, the research of the program's effectiveness consists primarily of poster presentations and a handful of dissertations. One study found parents were better able to apply strategies and reported less stress when the parents were trained supplemental to their child's treatment. The effectiveness of the Competent Learner Model as implemented by parents independent of other treatment is unknown. Parent training using the Competent Learner Model may provide access to effective treatment for families. If this program is effective in training parents, it will increase access to effective services, decrease the amount of face-to-face time a parent must spend with a clinician and, thus, allow the clinician to serve a greater number of families simultaneously. More broadly, this treatment approach may present a treatment option for rural Americans with limited access to behavioral health outside of West Virginia as well. The study will contribute to the literature of training parents as therapists for their children with Autism.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Families were recruited through healthcare offices including primary care and behavioral health offices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Session Attendance
Time frame: Up to 16 weeks
Number of sessions attended divided by total session
Homework Completion
Time frame: Up to 16 weeks
Number of training units completed in entirety divided by total units
2 secondary outcomes
Parenting Stress Index Fourth Edition
Time frame: From baseline to post intervention, up to 4 months
Parent Sense of Competence Scale
Time frame: From baseline to post intervention, up to 4 months
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 18 Jun 2021.
- Background: PubMed 26430947Smith T, Iadarola S. Evidence Base Update for Autism Spectrum Disorder. J Clin Child Adolesc Psychol. 2015;44(6):897-922. doi: 10.1080/15374416.2015.1077448.
- Background: PubMed 18205039Kaminski JW, Valle LA, Filene JH, Boyle CL. A meta-analytic review of components associated with parent training program effectiveness. J Abnorm Child Psychol. 2008 May;36(4):567-89. doi: 10.1007/s10802-007-9201-9. Epub 2008 Jan 19.
- Background: PubMed 17286734McConachie H, Diggle T. Parent implemented early intervention for young children with autism spectrum disorder: a systematic review. J Eval Clin Pract. 2007 Feb;13(1):120-9. doi: 10.1111/j.1365-2753.2006.00674.x.
- Background: PubMed 16795561Stokes TF, Baer DM. An implicit technology of generalization. J Appl Behav Anal. 1977 Summer;10(2):349-67. doi: 10.1901/jaba.1977.10-349.
- Background: PubMed 29701730Baio J, Wiggins L, Christensen DL, Maenner MJ, Daniels J, Warren Z, Kurzius-Spencer M, Zahorodny W, Robinson Rosenberg C, White T, Durkin MS, Imm P, Nikolaou L, Yeargin-Allsopp M, Lee LC, Harrington R, Lopez M, Fitzgerald RT, Hewitt A, Pettygrove S, Constantino JN, Vehorn A, Shenouda J, Hall-Lande J, Van Naarden Braun K, Dowling NF. Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2014. MMWR Surveill Summ. 2018 Apr 27;67(6):1-23. doi: 10.15585/mmwr.ss6706a1.
- BackgroundMancil G. R., Boyd, B. A., & Bedersem, P. Parental stress and autism: Are there useful coping strategies? Education and Training in Developmental Disabilities. 2009; 44:4; 523-537.
- BackgroundBurrell, T. L., & Borrego, J. Parents' involvement in ASD treatment: What is their role? Cognitive and Behavioral Practice. 2012; 19(3): 423-432.
- BackgroundTucci, V., Hursh, D., Laitinen, R., & Lambe, A. Competent learner model for individuals with autism/ PDD. Exceptionality. 2005; 13(1); 55-63.
- BackgroundLofton, K. L. Autism services lacking for West Virginia families. Appalachia Health News. April 6, 2016. wvpublic.org/post/autism-services-lacking-west-virginia-families. Accessed March 5, 2018.
- Individual participant dataSharing planned: Undecided. Researchers may share data from the current study based on individual request from the other researcher
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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?
An observational study of Autism Spectrum Disorder, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. 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?
Session Attendance (time frame: Up to 16 weeks). 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?
On the ClinicalTrials.gov record for NCT04931043, which also lists 9 linked publications.
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 18 Jun 2021.