Clinical trial NCT02708069: e-Unstuck:Interactive e-Learning Software for Parents to Support Executive Functioning and Behavior Regulation in Children With Autism Spectrum Disorder
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
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Disorder
Keywords: Autism Spectrum Disorder
Lead sponsor: 3-C Institute for Social Development
Sponsor class: INDUSTRY
Collaborators: name: Children's National Health System
First posted: 2016-03-15
Enrollment: 97
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change from baseline in ratings of top three child EF difficulties interference with daily functioning as measured on the Top Executive Functioning Difficulties.
timeFrame: After 9 weeks of parental UOT Training
Secondary outcomes:
measure: Change from baseline in child executive function using the Behavior Rating of Executive Function-II (BRIEF-II).
timeFrame: After 9 weeks of parental UOT Training
measure: Change from baseline in parental self-efficacy on the Parenting Sense of Competence Scale.
timeFrame: After 9 weeks of parental UOT Training
measure: Change from Baseline in parental perceptions of caregiving as measured on the Caregiver Questionnaire
timeFrame: After 9 weeks of parental UOT Training
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Children's National Health System
state: Maryland
city: Durham
country: United States
facility: 3C Institute
state: North Carolina
Study officials:
affiliation: 3C Institute
name: Debra Childress, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's National Health System
name: Lauren Kenworthy, PhD
role: PRINCIPAL_INVESTIGATOR
References: