Autistic Disorder Clinical Trial
— e-UnstuckOfficial title:
e-Unstuck: Interactive e-Learning Software for Parents to Support Executive Functioning and Behavior Regulation in Children With Autism Spectrum Disorder
Verified date | July 2018 |
Source | 3-C Institute for Social Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 97 |
Est. completion date | February 28, 2018 |
Est. primary completion date | February 28, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | 3C Institute | Durham | North Carolina |
United States | Children's National Health System | Rockville | Maryland |
Lead Sponsor | Collaborator |
---|---|
3-C Institute for Social Development | Children's National Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | After 9 weeks of parental UOT Training | |
Secondary | 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. | After 9 weeks of parental UOT Training | |
Secondary | 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. | After 9 weeks of parental UOT Training |
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