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ASD Parent Trainer: Online Coaching for Parents of Children With Autism (APT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469870
Recruitment Status : Completed
First Posted : June 12, 2015
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
IRIS Media Inc

Tracking Information
First Submitted Date  ICMJE June 8, 2015
First Posted Date  ICMJE June 12, 2015
Results First Submitted Date  ICMJE January 6, 2020
Results First Posted Date  ICMJE February 5, 2020
Last Update Posted Date February 5, 2020
Study Start Date  ICMJE August 2016
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • Child Behavior Measured by Strengths and Difficulties Questionnaire (Goodman, 1997) [ Time Frame: Pre (0 weeks), Post (3 weeks) ]
    Examining change over time points (T2-T1) This 25-item parent-report version of a behavioral screening questionnaire has been used with children aged 3 to 16 years of age. It assesses both positive and negative behaviors in the following domains: conduct problems, inattention-hyperactivity, emotional symptoms, peer problems, and pro-social behavior. The SDQ-P has demonstrated acceptable psychometric properties and is available in Spanish (Goodman, 2001).Total range of scores is from 0 to 50. The prosocial items are reverse scored for the total scale so that on the total scale higher scores indicate worse behaviors.
  • Family Quality of Life as Measured by Family Quality of Life Survey (Summers et al., 2005) [ Time Frame: Pre (0 weeks), Post (3 weeks) ]
    Examining change over time points (T2-T1) Quality of Life was measured using the Family Quality of Life survey (FQOL; Summers et al., 2005), which is a 25-item measure of the quality of life for a family raising a child with intellectual or developmental disabilities. The outcomes measured are: quality of life in the domains of parenting, emotional well-being, physical/material well-being, and disability-related supports using a 5-point scale with responses ranging from (1) very dissatisfied to (5) very satisfied. The average score on the total scale was used in the analysis. The range is from 1 to 5 with higher scores indicating more positive outcomes.
  • Parenting Scale (Arnold, O'Leary, Wolff, & Aker, 1993) [ Time Frame: Pre (0 weeks), Post (3 weeks), ]
    Examining change over time points (T2-T1) Parenting Practices will be assessed using the Parenting Scale (PS; Arnold, O'Leary, Wolff, & Aker, 1993) a 30-item, 7 point Likert-like scale with three subscales (laxness, over-reactivity, and hostility). The scale has internal consistency for the total scale and subscales (α = .78 and - .83 respectively) and has been evaluated for factor structure and validity (Rhoades & O'Leary, 2007). The average score on the total scale was used in the analysis with a range of 1 to 7 with lower scores indicating more positive outcomes.
  • Scales of Independent Behavior-Revised (SIB-R; Bruininks, Woodcock, Weatherman, & Hill, 1996) [ Time Frame: Pre (0 weeks), Post (3 weeks) ]
    Examining change over time points (T2-T1) The SBI-R is a 40-item, 7-point scale that measures 14 areas of adaptive behaviors and 8 areas of maladaptive behaviors. We used the total adaptive scale with a total range of 0 to 120 with higher scores indicating better outcomes.
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2015)
  • Child Behavior Measured by Strengths and Difficulties Questionnaire (Goodman, 1997) [ Time Frame: Pre (0 weeks), Post (3 weeks), Followup (6 weeks) ]
    Examining change over time points (T2-T1 and T3-T1)
  • Family Quality of Life as Measured by Family Quality of Life Survey (Summers et al., 2005) [ Time Frame: Pre (0 weeks), Post (3 weeks), Followup (6 weeks) ]
    Examining change over time points (T2-T1 and T3-T1)
  • Parenting Behaviors and measured by Parenting Scale (Arnold, O'Leary, Wolff, & Aker, 1993) [ Time Frame: Pre (0 weeks), Post (3 weeks), Followup (6 weeks) ]
    Examining change over time points (T2-T1 and T3-T1)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • Knowledge About Applied Behavior Analysis and Acceptance Commitment Training Measured by Questionnaire [ Time Frame: Pre (0 weeks), Post (3 weeks) ]
    Examining change over time points (T2-T1) 20 multiple choice knowledge items were developed during the project and were used to determine the extent to which participants understood basic program content, e.g., techniques parents can use to help their child master self-care routines. These included questions about the principles of behavior support (gathering information, evaluating possible reinforcers, etc.), definitions of behavioral concepts (tantrums, reinforcement, antecedent), and application of these concepts. The total score ranged from 0 to 20 with higher scores indicating better outcomes.
  • Consumer Satisfaction Questionnaire [ Time Frame: Follow up (6 weeks) ]
    A 16-item scale was developed to evaluate parents' views of the feasibility, usability, and personal relevance of the program. It asked about the information taught in the program, the trainers, the website, and the other materials. The average score on these 19 items was evaluated and ranged from 1 to 6 with higher scores indicating more positive outcomes.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2015)
  • Knowledge about Applied Behavior Analysis and Acceptance Commitment Training measured by Questionnaire [ Time Frame: Pre (0 weeks), Post (3 weeks), Followup (6 weeks) ]
    Examining change over time points (T2-T1 and T3-T1)
  • Consumer Satisfaction Questionnaire [ Time Frame: Post (3 weeks) ]
  • Implementation Adherence Questionnaire [ Time Frame: Post (3 weeks) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ASD Parent Trainer: Online Coaching for Parents of Children With Autism
Official Title  ICMJE Not Provided
Brief Summary The evaluation of the program efficacy will be conducted via a randomized control study with 136 parents of children aged 3-8 who have autism. Investigators will test whether, compared to a content comparison group (CC), administration of the APT program over a 3-week intervention period (a) improves child behaviors, (b) increases perceived quality of life, (c) decreases parental stress, (d) increases positive parenting practices, and (e) increases parent knowledge of evidence-based support practices.
Detailed Description

Participants. The sample will consist of parents who have at least one child diagnosed with autism (aged 3 to 8) and have access to the Internet. From investigators experience in the Phase I and similar studies, an attrition rate of less than 30% is expected. 180 parents (90 per condition) will ensure that the final sample will be no fewer than 136, with 68 in each condition. Participation will be open to two-parent and single-parent families; only one parent per family will be invited to participate in data collection. No parental age, gender, or race exclusions will apply.

Procedure. All research will be conducted online. IRIS Ed has extensive experience conducting online studies, and has developed successful recruitment, retention, and assessment procedures. Screening, consent, and data collection will be conducted using Qualtrics (see Human Subjects). Google+ Hangouts will be used to conduct the interactive APT training. The CC training materials will be hosted on irisEd.com. Additional training materials will be hosted on YouTube and SoundCloud. Participants will be recruited nationally using approaches and resources that have yielded results in past online interventions.

The APT study will adhere to the following procedures: potential participants will be directed to the recruitment website on Qualtrics and will be screened for eligibility on the following inclusion criteria: (a) have a child aged 3-8 diagnosed with autism and living with the parent, (b) have access to email and an Internet connection, and (c) have access to a computer or other mobile device with a camera and a microphone. Eligible participants will be given a brief explanation of the study and participation requirements, and will be asked to complete an online informed consent (see Human Subjects). Participants will then complete the pretest measures (see Table 3). Upon pretest completion, parents will be randomly assigned to either the APT intervention condition or a content comparison (CC) group.

Content Comparison (CC). Parents assigned to the CC will be given access to a self-paced online training program covering the same content as APT. The CC group will receive an online program that delivers antecedent-behavior-consequence (ABC) multimedia instruction that is targeted to parents. For this purpose, investigators and the curriculum designer will adapt a program developed by IRIS entitled Teaching Routines to Children Who Have ASD, A Parent's Guide to the ABC Method. The ABC Method demonstrated in a pre-posttest design that web-based instruction in applied behavioral analytical (ABA) strategies, such as ABC, was effective in helping parents teach children basic self-help skills, and allowed parents to apply this method to a range of skills. The original ABC Method program consisted of nine multimedia lessons (modeling videos, animated sequences, interactive exercises, downloadable summaries) designed to help parents understand and use the antecedent-behavior-consequence concept derived from ABA. Each lesson contained a 3 to 5 minute video that uses simple language, realistic live action, and animation to illustrate a concept and to model how parents can apply the concept as they teach a routine. Each lesson also contained an interactive exercise and printed summary to guide parents through the steps of creating a teaching plan tailored to the needs of their children.

To ensure that the CC group receives a dosage equivalent to that of the APT Intervention group, the original program will be reformatted so that it is delivered in 3 rather than 9 lessons. This will require re-editing the original materials, creating new introductions to the three lessons, and making corresponding changes in how the program is delivered by our online Learning Management System. Investigators will also ensure that the reformatted program possesses equivalent validity with the original program. Investigators and the development team will achieve this by enlisting a small test group of parents in an iterative process of review and refinement as the program is reformatted. Parents in the CC will have 3 weeks in which to access the program. Web metrics will allow investigators to track adherence to program fidelity.

Treatment. Parents in the APT group will be presented with the dates and times of available training groups and asked to select their preference. They will then receive an access code for logging on to the APT web hub to view the training materials. Participants will also be given access to the videoconferencing workshops, and will test to ensure they can access the site and that their camera and microphone are operating. IRIS Ed technical staff will be available to assist with any difficulties. Each week, for three weeks participants in the APT condition will meet with their training group and the APT Parent Educator for 120 minutes of instruction, discussion, and problem solving. They will also complete assigned homework, including watching online video trainings.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Autism Disorder
Intervention  ICMJE
  • Behavioral: Autism Parent Trainer (APT)
    Experimental condition
  • Behavioral: Teaching Routines (Control)
    Content comparison group.
Study Arms  ICMJE
  • Experimental: Autism Parent Trainer (APT)
    Practiced Routines was a facilitated program. It was organized into four modules that included a total of seven videos ranging from 3-13 minutes each. The topics overlapped with those in the TR program, but included more explicit information on function-based strategies, as well as mindfulness practice. Participants were assigned six fillable forms, and provided supplemental data collection tools. Additional resources focused on mindfulness and PBS within family routines. Eighteen brief guided audio meditations were available to participants via the Practiced MindTM mobile application. The meditations focused on bringing the parents' awareness to both internal and external experiences and helping them act intentionally.
    Intervention: Behavioral: Autism Parent Trainer (APT)
  • Active Comparator: Teaching Routines (Control
    Teaching Routines was entirely self-directed. The program included eight modules with videos for each ranging 3 - 5 minutes in duration. The topics were antecedent-behavior-consequence method, creating task analyses, antecedent-based strategies, communication, reinforcement, teaching methods, and overcoming obstacles. Participants were assigned six activities using fillable forms and provided additional resources including examples, a glossary of terms, and a list of websites. No feedback was given to the parents apart from the automated completion responses. The participants were given access to the TR LMS for the duration of the study, but post and follow-up assessments were completed at 6 and 10 weeks (i.e., same as the PR condition).
    Intervention: Behavioral: Teaching Routines (Control)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2020)
156
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2015)
180
Actual Study Completion Date  ICMJE October 30, 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Parents of children aged 3-8 who have autism

Exclusion Criteria:

  • none
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02469870
Other Study ID Numbers  ICMJE 2R44MH102845-02( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party IRIS Media Inc
Study Sponsor  ICMJE IRIS Media Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nell Caraway, BA IRIS Educational Media
Principal Investigator: Meme Hieneman, Ph.D., BCBA IRIS Educational Media
PRS Account IRIS Media Inc
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP