Trial Outcomes & Findings for ASD Parent Trainer: Online Coaching for Parents of Children With Autism (NCT NCT02469870)

Last Updated: 2020-02-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

156 participants

Primary outcome timeframe

Pre (0 weeks), Post (3 weeks)

Results posted on

2020-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Autism Parent Trainer (APT) Autism Parent Trainer (APT) Experimental Condition. 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.	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).
Overall Study STARTED	77	79
Overall Study COMPLETED	73	72
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autism Parent Trainer (APT) n=77 Participants Autism Parent Trainer (APT) Experimental Condition. 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.	Teaching Routines (Control) n=79 Participants 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).	Total n=156 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	77 Participants n=5 Participants	79 Participants n=7 Participants	156 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37.4 years STANDARD_DEVIATION 5.9 • n=5 Participants	36.1 years STANDARD_DEVIATION 5.5 • n=7 Participants	36.7 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	77 Participants n=7 Participants	152 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	67 Participants n=5 Participants	62 Participants n=7 Participants	129 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	56 Participants n=5 Participants	66 Participants n=7 Participants	122 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	77 participants n=5 Participants	79 participants n=7 Participants	156 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre (0 weeks), Post (3 weeks)

Outcome measures

Outcome measures
Measure	Autism Parent Trainer (APT) n=77 Participants Autism Parent Trainer (APT) Experimental Condition. This group will receive Google Hangouts training on autism and lifestyle coaching.	Teaching Routines (Control) n=79 Participants 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).
Child Behavior Measured by Strengths and Difficulties Questionnaire (Goodman, 1997)	19.27 total score on a scale Standard Deviation 5.2	21.00 total score on a scale Standard Deviation 5.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Autism Parent Trainer (APT) n=77 Participants Autism Parent Trainer (APT) Experimental Condition. This group will receive Google Hangouts training on autism and lifestyle coaching.	Teaching Routines (Control) n=79 Participants 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).
Family Quality of Life as Measured by Family Quality of Life Survey (Summers et al., 2005)	3.99 average score on a scale Standard Deviation .5	3.86 average score on a scale Standard Deviation .6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Autism Parent Trainer (APT) n=77 Participants Autism Parent Trainer (APT) Experimental Condition. This group will receive Google Hangouts training on autism and lifestyle coaching.	Teaching Routines (Control) n=79 Participants 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).
Parenting Scale (Arnold, O'Leary, Wolff, & Aker, 1993)	3.7 average score on a scale Standard Deviation .6	3.72 average score on a scale Standard Deviation .3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Autism Parent Trainer (APT) n=77 Participants Autism Parent Trainer (APT) Experimental Condition. This group will receive Google Hangouts training on autism and lifestyle coaching.	Teaching Routines (Control) n=79 Participants 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).
Scales of Independent Behavior-Revised (SIB-R; Bruininks, Woodcock, Weatherman, & Hill, 1996)	65.56 total score on a scale Standard Deviation 15.4	63.87 total score on a scale Standard Deviation 16.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Autism Parent Trainer (APT) n=77 Participants Autism Parent Trainer (APT) Experimental Condition. This group will receive Google Hangouts training on autism and lifestyle coaching.	Teaching Routines (Control) n=79 Participants 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).
Knowledge About Applied Behavior Analysis and Acceptance Commitment Training Measured by Questionnaire	14.52 total correct answers Standard Deviation 2.7	13.37 total correct answers Standard Deviation 2.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Autism Parent Trainer (APT) n=77 Participants Autism Parent Trainer (APT) Experimental Condition. This group will receive Google Hangouts training on autism and lifestyle coaching.	Teaching Routines (Control) n=79 Participants 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).
Consumer Satisfaction Questionnaire	5.50 average score on a scale Standard Deviation .67	5.24 average score on a scale Standard Deviation .88

Adverse Events

Autism Parent Trainer (APT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Teaching Routines (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jordan Pennefather

Trifoia

Phone: 1-877-874-3642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place