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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Autism Disorder
Interventions Behavioral: Autism Parent Trainer (APT)
Behavioral: Teaching Routines (Control)
Enrollment 156
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Autism Parent Trainer (APT) Teaching Routines (Control)
Hide Arm/Group Description

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 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).
Period Title: Overall Study
Started 77 79
Completed 73 72
Not Completed 4 7
Arm/Group Title Autism Parent Trainer (APT) Teaching Routines (Control) Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 77 79 156
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 79 participants 156 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
77
 100.0%
79
 100.0%
156
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 79 participants 156 participants
37.4  (5.9) 36.1  (5.5) 36.7  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 79 participants 156 participants
Female
75
  97.4%
77
  97.5%
152
  97.4%
Male
2
   2.6%
2
   2.5%
4
   2.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 79 participants 156 participants
Hispanic or Latino
8
  10.4%
13
  16.5%
21
  13.5%
Not Hispanic or Latino
67
  87.0%
62
  78.5%
129
  82.7%
Unknown or Not Reported
2
   2.6%
4
   5.1%
6
   3.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 79 participants 156 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.6%
1
   1.3%
3
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
  16.9%
5
   6.3%
18
  11.5%
White
56
  72.7%
66
  83.5%
122
  78.2%
More than one race
3
   3.9%
5
   6.3%
8
   5.1%
Unknown or Not Reported
3
   3.9%
2
   2.5%
5
   3.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 77 participants 79 participants 156 participants
77 79 156
1.Primary Outcome
Title Child Behavior Measured by Strengths and Difficulties Questionnaire (Goodman, 1997)
Hide Description 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.
Time Frame Pre (0 weeks), Post (3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autism Parent Trainer (APT) Teaching Routines (Control)
Hide Arm/Group Description:
Autism Parent Trainer (APT) Experimental Condition. This group will receive Google Hangouts training on autism and lifestyle coaching.
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 Number of Participants Analyzed 77 79
Mean (Standard Deviation)
Unit of Measure: total score on a scale
19.27  (5.2) 21.00  (5.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Autism Parent Trainer (APT), Teaching Routines (Control)
Comments To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .598
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Family Quality of Life as Measured by Family Quality of Life Survey (Summers et al., 2005)
Hide Description 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.
Time Frame Pre (0 weeks), Post (3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autism Parent Trainer (APT) Teaching Routines (Control
Hide Arm/Group Description:

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.

Autism Parent Trainer (APT): Experimental condition

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).

Teaching Routines (Control): Content comparison group.

Overall Number of Participants Analyzed 77 79
Mean (Standard Deviation)
Unit of Measure: average score on a scale
3.99  (.5) 3.86  (.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Autism Parent Trainer (APT), Teaching Routines (Control
Comments . To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .81
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Parenting Scale (Arnold, O'Leary, Wolff, & Aker, 1993)
Hide Description 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.
Time Frame Pre (0 weeks), Post (3 weeks),
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autism Parent Trainer (APT) Teaching Routines (Control)
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 77 79
Mean (Standard Deviation)
Unit of Measure: average score on a scale
3.7  (.6) 3.72  (.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Autism Parent Trainer (APT), Teaching Routines (Control)
Comments . To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .404
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Primary Outcome
Title Scales of Independent Behavior-Revised (SIB-R; Bruininks, Woodcock, Weatherman, & Hill, 1996)
Hide Description

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.

Time Frame Pre (0 weeks), Post (3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autism Parent Trainer (APT) Teaching Routines (Control)
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 77 79
Mean (Standard Deviation)
Unit of Measure: total score on a scale
65.56  (15.4) 63.87  (16.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Autism Parent Trainer (APT), Teaching Routines (Control)
Comments . To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .246
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Knowledge About Applied Behavior Analysis and Acceptance Commitment Training Measured by Questionnaire
Hide Description 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.
Time Frame Pre (0 weeks), Post (3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autism Parent Trainer (APT) Teaching Routines (Control)
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 77 79
Mean (Standard Deviation)
Unit of Measure: total correct answers
14.52  (2.7) 13.37  (2.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Autism Parent Trainer (APT), Teaching Routines (Control)
Comments . To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Consumer Satisfaction Questionnaire
Hide Description 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.
Time Frame Follow up (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autism Parent Trainer (APT) Teaching Routines (Control)
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 77 79
Mean (Standard Deviation)
Unit of Measure: average score on a scale
5.50  (.67) 5.24  (.88)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Autism Parent Trainer (APT), Teaching Routines (Control)
Comments Two-sample t-test
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .045
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Six weeks from pretest to follow-up.
Adverse Event Reporting Description This was a self-selected behavioral training program for parents of children with Autism.
 
Arm/Group Title Autism Parent Trainer (APT) Teaching Routines (Control)
Hide Arm/Group Description

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 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).
All-Cause Mortality
Autism Parent Trainer (APT) Teaching Routines (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/77 (0.00%)   0/79 (0.00%) 
Hide Serious Adverse Events
Autism Parent Trainer (APT) Teaching Routines (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/77 (0.00%)   0/79 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Autism Parent Trainer (APT) Teaching Routines (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/77 (0.00%)   0/79 (0.00%) 
The most significant limitation of this study was that it was underpowered for a content comparison study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jordan Pennefather
Organization: Trifoia
Phone: 1-877-874-3642
EMail: jordanp@trifoia.com
Layout table for additonal information
Responsible Party: IRIS Media Inc
ClinicalTrials.gov Identifier: NCT02469870    
Other Study ID Numbers: 2R44MH102845-02 ( U.S. NIH Grant/Contract )
First Submitted: June 8, 2015
First Posted: June 12, 2015
Results First Submitted: January 6, 2020
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020