- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04931043
Feasibility of Competent Learner Model With Families of Children With ASD
Feasibility of Parent Training Using the Competent Learner Model With Families of Children With Autism Spectrum Disorder
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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West Virginia
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Martinsburg, West Virginia, United States, 25401
- West Virginia University Medicine University Behavioral Medicine and Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Session Attendance
Time Frame: Up to 16 weeks
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Number of sessions attended divided by total session
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Up to 16 weeks
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Homework Completion
Time Frame: Up to 16 weeks
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Number of training units completed in entirety divided by total units
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Up to 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Parenting Stress Index Fourth Edition
Time Frame: From baseline to post intervention, up to 4 months
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36-item parent report questionnaire assessing stress in parent-child relationships, dysfunctional parenting, and child adjustment problems
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From baseline to post intervention, up to 4 months
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Parent Sense of Competence Scale
Time Frame: From baseline to post intervention, up to 4 months
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Parent-report questionnaire assessing parenting attitudes and behaviors
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From baseline to post intervention, up to 4 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kaminski 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.
- Stokes 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.
- McConachie 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.
- 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.
- Baio 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. Erratum In: MMWR Morb Mortal Wkly Rep. 2018 May 18;67(19):564. MMWR Morb Mortal Wkly Rep. 2018 Nov 16;67(45):1280.
- Mancil 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1803052856
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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