This trial is active, not recruiting.

Condition autism disorder
Treatments autism parent trainer (apt), self-paced abc training online
Phase phase 2
Sponsor IRIS Media Inc
Start date August 2016
End date June 2017
Trial size 180 participants
Trial identifier NCT02469870, 2R44MH102845-02


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Autism Parent Trainer (APT) Experimental Condition. This group will receive Google Hangouts training on autism and lifestyle coaching. self-paced ABC training online - Parents assigned to the CC will be given access to a self-paced online training program covering the same content as APT.
autism parent trainer (apt)
Experimental condition
self-paced abc training online
Content comparison group.

Primary Outcomes

Child Behavior measured by Strengths and Difficulties Questionnaire (Goodman, 1997)
time frame: Pre (0 weeks), Post (3 weeks), Followup (6 weeks)
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)
Parenting Behaviors and measured by Parenting Scale (Arnold, O'Leary, Wolff, & Aker, 1993)
time frame: Pre (0 weeks), Post (3 weeks), Followup (6 weeks)

Secondary Outcomes

Knowledge about Applied Behavior Analysis and Acceptance Commitment Training measured by Questionnaire
time frame: Pre (0 weeks), Post (3 weeks), Followup (6 weeks)
Consumer Satisfaction Questionnaire
time frame: Post (3 weeks)
Implementation Adherence Questionnaire
time frame: Post (3 weeks)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Parents of children aged 3-8 who have autism Exclusion Criteria:

Additional Information

Principal investigator Nell Caraway, BA
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by IRIS Media Inc.