NCT02469870

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

June 8, 2015

Results QC Date

January 6, 2020

Last Update Submit

January 28, 2020

Conditions

Keywords

Parents of children who have autismvideo-conferencingApplied Behavior AnalysisAcceptance Commitment Trainingoptimism trainingPositive Behavior Support

Outcome Measures

Primary Outcomes (4)

  • Child Behavior Measured by Strengths and Difficulties Questionnaire (Goodman, 1997)

    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.

    Pre (0 weeks), Post (3 weeks)

  • Family Quality of Life as Measured by Family Quality of Life Survey (Summers et al., 2005)

    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.

    Pre (0 weeks), Post (3 weeks)

  • Parenting Scale (Arnold, O'Leary, Wolff, & Aker, 1993)

    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.

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

  • Scales of Independent Behavior-Revised (SIB-R; Bruininks, Woodcock, Weatherman, & Hill, 1996)

    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.

    Pre (0 weeks), Post (3 weeks)

Secondary Outcomes (2)

  • Knowledge About Applied Behavior Analysis and Acceptance Commitment Training Measured by Questionnaire

    Pre (0 weeks), Post (3 weeks)

  • Consumer Satisfaction Questionnaire

    Follow up (6 weeks)

Study Arms (2)

Autism Parent Trainer (APT)

EXPERIMENTAL

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.

Behavioral: Autism Parent Trainer (APT)

Teaching Routines (Control

ACTIVE COMPARATOR

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).

Behavioral: Teaching Routines (Control)

Interventions

Experimental condition

Autism Parent Trainer (APT)

Content comparison group.

Teaching Routines (Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents of children aged 3-8 who have autism

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRIS Educational Media

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Limitations and Caveats

The most significant limitation of this study was that it was underpowered for a content comparison study.

Results Point of Contact

Title
Dr. Jordan Pennefather
Organization
Trifoia

Study Officials

  • Nell Caraway, BA

    IRIS Educational Media

    PRINCIPAL INVESTIGATOR
  • Meme Hieneman, Ph.D., BCBA

    IRIS Educational Media

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 12, 2015

Study Start

August 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 30, 2017

Last Updated

February 5, 2020

Results First Posted

February 5, 2020

Record last verified: 2020-01

Locations