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e-Unstuck:Interactive e-Learning Software for Parents to Support Executive Functioning and Behavior Regulation in Children With Autism Spectrum Disorder (e-Unstuck)

Primary Purpose

Autistic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
e-Unstuck
Unstuck and On Target
Sponsored by
3-C Institute for Social Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autistic Disorder focused on measuring Autism Spectrum Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (Parents):

  • be fluent English speakers,
  • have a child aged 8-12 years old who has received an ASD diagnosis without intellectual disability from a community mental health professional, and
  • have a child that (1) Qualify for an ASD diagnosis based on expert clinical judgment using DSM-5 criteria and by meeting criteria on the Autism Diagnostic Observation Schedule (ADOS), (2) IQ and verbal mental age will not be impaired on an IQ test, and (3) Shift Scale or Plan/Organize Scale will also show clinical impairment on the BRIEF.
  • be able to access a computer with internet.
  • be able to travel to study sites in Rockville, MD and Washington, DC.

Inclusion Criteria (Children)

  • Qualify for an ASD diagnosis based on expert clinical judgment using DSM-5 criteria and Social Affect and Restricted and Repetitive Behavior Total ≥ 7 on the ADOS/ADOS-2,
  • IQ ≥ 70 and verbal mental age ≥ 8 years on the WASI-II, and
  • Shift Scale or Plan/Organize Scale ≥ 60 on the BRIEF.

Exclusion Criteria:

- Parents who previously participated in feasibility testing (Phase I, Aim 2), usability testing (Phase II, Aim 1), a prior study of the Unstuck and On Target (UOT) curriculum, or in-person training of the UOT curriculum will be excluded due to their familiarity with the curriculum.

Sites / Locations

  • Children's National Health System
  • 3C Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

e-Unstuck condition

In-Person condition

Arm Description

Parents in the e-Unstuck condition will be asked to complete each of the e-Unstuck modules (one per week) over the course of the nine-week intervention, in addition to reading the UOT manual.

Parents participating in the in-person condition will be asked to attend two in-person trainings (approximately 125 and 100 minutes respectively) on the Unstuck and On Target (UOT) curriculum, in addition to reading the UOT manual.

Outcomes

Primary Outcome Measures

Change from baseline in ratings of top three child EF difficulties interference with daily functioning as measured on the Top Executive Functioning Difficulties.
On this parent-report measure parents rank their child's top 3 EF difficulties and, using a 4 point likert scale (1-no interference to 4-severely interfering), indicate to what extent each difficulty interferes with 5 aspects of their child's daily functioning-daily activities, social activities, follow directions, independence, and task completion. Each difficulty interference score is calculated by summing the 5 rated items and weighted by rank.

Secondary Outcome Measures

Change from baseline in child executive function using the Behavior Rating of Executive Function-II (BRIEF-II).
This parent-report questionnaire contains 86 items and assesses child EF skills, including flexibility and planning/organization. For this scale, higher T-scores corresponding to higher levels of executive function impairment.
Change from baseline in parental self-efficacy on the Parenting Sense of Competence Scale.
In this 17-item scale, parents report on their satisfaction (e.g., anxiety, motivation) and self-efficacy (e.g., competence, capability) as parents. The index uses a 6 point likert scale (1-strongly agree to 6-strongly disagree). Scoring for multiple items is reverses so that for all items, higher scores indicate greater self-esteem and self-efficacy.
Change from Baseline in parental perceptions of caregiving as measured on the Caregiver Questionnaire
This questionnaire contains 21 items and parents report on their sense of child-related strain, competence and empowerment. The items are rated on a 5 point likert scale (1-not at all to 5-very much). Each subscale score is the sum total of the appropriate 7 items, with higher scores indicating higher perceived strain, sense of competence and empowerment.

Full Information

First Posted
February 24, 2016
Last Updated
July 30, 2018
Sponsor
3-C Institute for Social Development
Collaborators
Children's National Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02708069
Brief Title
e-Unstuck:Interactive e-Learning Software for Parents to Support Executive Functioning and Behavior Regulation in Children With Autism Spectrum Disorder
Acronym
e-Unstuck
Official Title
e-Unstuck: Interactive e-Learning Software for Parents to Support Executive Functioning and Behavior Regulation in Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3-C Institute for Social Development
Collaborators
Children's National Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this project is to develop and test e-Unstuck, an e-learning intervention that (1) provides advanced training to parents of children with Autism Spectrum Disorder without Intellectual Disability (ASDwoID) on how to implement the evidence-based Unstuck and On Target (UOT) curriculum at home and (2) is built on 3C's proprietary, state-of-the-art, Dynamic e-Learning Platform, an established platform with high ratings of quality, value, usability, and feasibility from end users. As a result of the pilot efficacy test, the investigators hypothesize that (1) parents who interact with the e-Unstuck software will report greater knowledge and use of UOT principles, less parenting stress and greater parenting sense of competence, and improved child executive function (EF) and social skills compared to control parents, (2) parents who spend more time engaged with the intervention will show greater improvements in outcome variables, and (3) parents who interact with the e-Unstuck software will find the software to be of high quality, value, usability, and feasibility.
Detailed Description
Background and Significance: The current prevalence of Autism Spectrum Disorder is 1 in 68 children, and 69% of these children do not have an intellectual disability (ASDwoID). Individuals with ASDwoID are at considerable risk for maladaptive adult outcomes (e.g., un- or underemployment), and executive functioning (EF) impairments significantly contribute to this risk. Unstuck and On Target (UOT) is the only empirically supported EF intervention specifically targeted to the needs of the ASDwoID population. It has improved both EF and social skills in children with ASDwoID in a randomized controlled trial. Despite its demonstrated success, there are significant geographical, scheduling, and financial barriers to parental adaptation of the Unstuck and On Target (UOT) curriculum. Goal and Innovation: The goal of this project is to develop and test e-Unstuck, an e-learning intervention that (1) provides advanced training to parents of children with ASDwoID on how to implement the evidence-based UOT curriculum at home and (2) is built on 3C's proprietary, state-of-the-art, Dynamic e-Learning Platform, an established platform with high ratings of quality, value, usability, and feasibility from end users. e-Unstuck will make UOT more accessible to parents with geographical, scheduling, and/or financial constraints and will provide parents with key tools (e.g., video modeling, virtual simulations, personalized reports) to increase efficacious adoption of UOT principles, above and beyond those provided in the UOT manual. e-Unstuck will be the first dynamically adaptive, personalized, interactive software product specifically designed to deploy an evidence-based EF intervention to parents of children with ASDwoID. Specific Aims: The investigators will accomplish five specific aims, two in Phase I, and three in Phase II: (1) develop a prototype of e-Unstuck, (2) conduct a feasibility test of e-Unstuck with parents of children with ASDwoID between the ages of 8-12, (3) fully develop the e-Unstuck software and conduct iterative usability testing with parents of children with ASDwoID, (4) conduct a pilot efficacy test in which 110 parents of children with ASDwoID are randomly assigned to the e-Unstuck intervention or to a control condition in which they receive in-person training on the UOT curriculum, and (5) prepare e-Unstuck for commercialization. Hypotheses: As a result of the pilot efficacy test, the investigators hypothesize that (1) parents who interact with the e-Unstuck software will report greater knowledge and use of UOT principles, less parenting stress and greater parenting sense of competence, and improved child EF and social skills compared to control parents, (2) parents who spend more time engaged with the intervention will show greater improvements in outcome variables, and (3) parents who interact with the e-Unstuck software will find the software to be of high quality, value, usability, and feasibility. Commercialization Plan: e-Unstuck will be a unique commercial offering within a large underserved niche market. Revenue will be generated through direct sales to parents of children with ASDwoID and volume sales to organizations (e.g., schools, clinics, parent support agencies) who work with children with ASDwoID and their parents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
e-Unstuck condition
Arm Type
Other
Arm Description
Parents in the e-Unstuck condition will be asked to complete each of the e-Unstuck modules (one per week) over the course of the nine-week intervention, in addition to reading the UOT manual.
Arm Title
In-Person condition
Arm Type
Other
Arm Description
Parents participating in the in-person condition will be asked to attend two in-person trainings (approximately 125 and 100 minutes respectively) on the Unstuck and On Target (UOT) curriculum, in addition to reading the UOT manual.
Intervention Type
Other
Intervention Name(s)
e-Unstuck
Intervention Description
An e-learning software that delivers the evidence-based Executive Functioning intervention to parents of children with Autism Spectrum Disorder without Intellectual Disability (ASDwoID) with personalized training and feedback on the evidence-based Unstuck and On Target (UOT) curriculum. Through video modeling, intelligent games, adaptive interactive exercises, and personalized feedback, e-Unstuck will provide parents with new tools for applying UOT principles to real world settings, above and beyond learning UOT principles.
Intervention Type
Other
Intervention Name(s)
Unstuck and On Target
Other Intervention Name(s)
UOT
Intervention Description
An executive functioning intervention specifically targeted to the needs of the Autism Spectrum Disorder without Intellectual Disability (ASDwoID) population.
Primary Outcome Measure Information:
Title
Change from baseline in ratings of top three child EF difficulties interference with daily functioning as measured on the Top Executive Functioning Difficulties.
Description
On this parent-report measure parents rank their child's top 3 EF difficulties and, using a 4 point likert scale (1-no interference to 4-severely interfering), indicate to what extent each difficulty interferes with 5 aspects of their child's daily functioning-daily activities, social activities, follow directions, independence, and task completion. Each difficulty interference score is calculated by summing the 5 rated items and weighted by rank.
Time Frame
After 9 weeks of parental UOT Training
Secondary Outcome Measure Information:
Title
Change from baseline in child executive function using the Behavior Rating of Executive Function-II (BRIEF-II).
Description
This parent-report questionnaire contains 86 items and assesses child EF skills, including flexibility and planning/organization. For this scale, higher T-scores corresponding to higher levels of executive function impairment.
Time Frame
After 9 weeks of parental UOT Training
Title
Change from baseline in parental self-efficacy on the Parenting Sense of Competence Scale.
Description
In this 17-item scale, parents report on their satisfaction (e.g., anxiety, motivation) and self-efficacy (e.g., competence, capability) as parents. The index uses a 6 point likert scale (1-strongly agree to 6-strongly disagree). Scoring for multiple items is reverses so that for all items, higher scores indicate greater self-esteem and self-efficacy.
Time Frame
After 9 weeks of parental UOT Training
Title
Change from Baseline in parental perceptions of caregiving as measured on the Caregiver Questionnaire
Description
This questionnaire contains 21 items and parents report on their sense of child-related strain, competence and empowerment. The items are rated on a 5 point likert scale (1-not at all to 5-very much). Each subscale score is the sum total of the appropriate 7 items, with higher scores indicating higher perceived strain, sense of competence and empowerment.
Time Frame
After 9 weeks of parental UOT Training

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (Parents): be fluent English speakers, have a child aged 8-12 years old who has received an ASD diagnosis without intellectual disability from a community mental health professional, and have a child that (1) Qualify for an ASD diagnosis based on expert clinical judgment using DSM-5 criteria and by meeting criteria on the Autism Diagnostic Observation Schedule (ADOS), (2) IQ and verbal mental age will not be impaired on an IQ test, and (3) Shift Scale or Plan/Organize Scale will also show clinical impairment on the BRIEF. be able to access a computer with internet. be able to travel to study sites in Rockville, MD and Washington, DC. Inclusion Criteria (Children) Qualify for an ASD diagnosis based on expert clinical judgment using DSM-5 criteria and Social Affect and Restricted and Repetitive Behavior Total ≥ 7 on the ADOS/ADOS-2, IQ ≥ 70 and verbal mental age ≥ 8 years on the WASI-II, and Shift Scale or Plan/Organize Scale ≥ 60 on the BRIEF. Exclusion Criteria: - Parents who previously participated in feasibility testing (Phase I, Aim 2), usability testing (Phase II, Aim 1), a prior study of the Unstuck and On Target (UOT) curriculum, or in-person training of the UOT curriculum will be excluded due to their familiarity with the curriculum.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Childress, PhD
Organizational Affiliation
3C Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lauren Kenworthy, PhD
Organizational Affiliation
Children's National Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Health System
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
3C Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States

12. IPD Sharing Statement

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e-Unstuck:Interactive e-Learning Software for Parents to Support Executive Functioning and Behavior Regulation in Children With Autism Spectrum Disorder

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