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

NCT02708069 | Completed

• 1 other identifier: 1R44MH109193
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 2

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.

Conditions

Autistic Disorder

Keywords

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  After 9 weeks of parental UOT Training

Secondary Outcomes (3)

• Change from baseline in child executive function using the Behavior Rating of Executive Function-II (BRIEF-II).

  After 9 weeks of parental UOT Training

• Change from baseline in parental self-efficacy on the Parenting Sense of Competence Scale.

  After 9 weeks of parental UOT Training

• Change from Baseline in parental perceptions of caregiving as measured on the Caregiver Questionnaire

  After 9 weeks of parental UOT Training

Study Arms (2)

e-Unstuck condition

OTHER

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.

Other: e-Unstuck

In-Person condition

OTHER

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.

Other: Unstuck and On Target

Interventions

e-Unstuck OTHER

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.

e-Unstuck condition

Unstuck and On Target OTHER

An executive functioning intervention specifically targeted to the needs of the Autism Spectrum Disorder without Intellectual Disability (ASDwoID) population.

Also known as: UOT

In-Person condition

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• 3-C Institute for Social Development: lead
• Children's National Research Institute: collaborator

Study Sites (2)

Children's National Health System

Rockville, Maryland, 20850, United States

Location

3C Institute

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Debra Childress, PhD

  3C Institute

  PRINCIPAL INVESTIGATOR

• Lauren Kenworthy, PhD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 15, 2016
• Study Start: March 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: July 31, 2018

Record last verified: 2018-07

Locations

US (2)