NCT04931043

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

April 29, 2021

Last Update Submit

June 10, 2021

Conditions

Keywords

Autism Spectrum DisorderParent TrainingApplied Behavior AnalysisRural

Outcome Measures

Primary Outcomes (2)

  • Session Attendance

    Number of sessions attended divided by total session

    Up to 16 weeks

  • Homework Completion

    Number of training units completed in entirety divided by total units

    Up to 16 weeks

Secondary Outcomes (2)

  • Parenting Stress Index Fourth Edition

    From baseline to post intervention, up to 4 months

  • Parent Sense of Competence Scale

    From baseline to post intervention, up to 4 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Families were recruited through healthcare offices including primary care and behavioral health offices.

You may qualify 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

You may not qualify if:

  • they were currently receiving intensive applied behavior analysis in the home
  • the caregiver would not consent to being videotaped.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University Medicine University Behavioral Medicine and Psychiatry

Martinsburg, West Virginia, 25401, United States

Location

Related Publications (9)

  • 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.

    PMID: 26430947BACKGROUND
  • 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.

    PMID: 18205039BACKGROUND
  • 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.

    PMID: 17286734BACKGROUND
  • 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.

    PMID: 16795561BACKGROUND
  • 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.

    PMID: 29701730BACKGROUND
  • 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.

    BACKGROUND
  • Burrell, T. L., & Borrego, J. Parents' involvement in ASD treatment: What is their role? Cognitive and Behavioral Practice. 2012; 19(3): 423-432.

    BACKGROUND
  • Tucci, V., Hursh, D., Laitinen, R., & Lambe, A. Competent learner model for individuals with autism/ PDD. Exceptionality. 2005; 13(1); 55-63.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 29, 2021

First Posted

June 18, 2021

Study Start

November 26, 2018

Primary Completion

June 12, 2019

Study Completion

June 12, 2019

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations