Clinical trial NCT02469870: ASD Parent Trainer: Online Coaching for Parents of Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Disorder
Keywords: Parents of children who have autism
video-conferencing
Applied Behavior Analysis
Acceptance Commitment Training
optimism training
Positive Behavior Support
Lead sponsor: IRIS Media Inc
Sponsor class: OTHER
First posted: 2015-06-12
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Parents of children aged 3-8 who have autism

Exclusion Criteria:

* none

Primary outcomes:
measure: Child Behavior Measured by Strengths and Difficulties Questionnaire (Goodman, 1997)
timeFrame: Pre (0 weeks), Post (3 weeks)
measure: Family Quality of Life as Measured by Family Quality of Life Survey (Summers et al., 2005)
timeFrame: Pre (0 weeks), Post (3 weeks)
measure: Parenting Scale (Arnold, O'Leary, Wolff, & Aker, 1993)
timeFrame: Pre (0 weeks), Post (3 weeks),
measure: Scales of Independent Behavior-Revised (SIB-R; Bruininks, Woodcock, Weatherman, & Hill, 1996)
timeFrame: Pre (0 weeks), Post (3 weeks)
Secondary outcomes:
measure: Knowledge About Applied Behavior Analysis and Acceptance Commitment Training Measured by Questionnaire
timeFrame: Pre (0 weeks), Post (3 weeks)
measure: Consumer Satisfaction Questionnaire
timeFrame: Follow up (6 weeks)
Other outcomes:
Locations:
city: Eugene
country: United States
facility: IRIS Educational Media
state: Oregon
Study officials:
affiliation: IRIS Educational Media
name: Nell Caraway, BA
role: PRINCIPAL_INVESTIGATOR
affiliation: IRIS Educational Media
name: Meme Hieneman, Ph.D., BCBA
role: PRINCIPAL_INVESTIGATOR
References: