Autistic Disordere-UnstuckNCT02708069
e-Unstuck:Interactive e-Learning Software for Parents to Support Executive Functioning and Behavior Regulation in Children With Autism Spectrum Disorder
A study testing e-Unstuck and Unstuck and On Target in people with Autistic Disorder, run by 3-C Institute for Social Development at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- e-Unstuck and Unstuck and On Target
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
3C Institute
Durham, North Carolina, 27713
Children's National Health System
Rockville, Maryland, 20850
About this study
Official title: e-Unstuck: Interactive e-Learning Software for Parents to Support Executive Functioning and Behavior Regulation in Children With Autism Spectrum Disorder
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.
Read the 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.
- Conditions
- Autistic Disorder
- Being tested
- e-Unstuck, Unstuck and On Target
- Keywords
- Autism Spectrum Disorder
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-UnstuckOther
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.
Unstuck and On TargetOther
Also called UOT
An executive functioning intervention specifically targeted to the needs of the Autism Spectrum Disorder without Intellectual Disability (ASDwoID) population.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Unstuck and On Target |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: After 9 weeks of parental UOT Training
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.
Measured: After 9 weeks of parental UOT Training
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.
Measured: After 9 weeks of parental UOT Training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study start1 Mar 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3-C Institute for Social Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's National Research Institute
- Responsible party
- Sponsor
- Investigators
- Debra Childress, PhD, Principal investigator, 3C InstituteLauren Kenworthy, PhD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708069
- Sponsor's protocol ID
- 1R44MH109193
- Acronym
- e-Unstuck
- Status last verified
- Jul 2018
- First submitted
- 24 Feb 2016
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-Unstuck: Interactive e-Learning Software for Parents to Support Executive Functioning and Behavior Regulation in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02708069
- Acronym / sponsor ID
- e-Unstuck / 1R44MH109193
- Conditions
- Autistic Disorder
- Keywords
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- 3-C Institute for Social DevelopmentIndustry (pharma, biotech, devices)
- Collaborators
- Children's National Research Institute
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e-Unstuck condition | Other | Other: e-UnstuckParents 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. |
| In-Person condition | Other | Other: Unstuck and On TargetParents 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-UnstuckAn 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. | Other | e-Unstuck condition |
| Unstuck and On TargetAlso: UOTAn executive functioning intervention specifically targeted to the needs of the Autism Spectrum Disorder without Intellectual Disability (ASDwoID) population. | Other | In-Person condition |
Primary outcome
Change from baseline in ratings of top three child EF difficulties interference with daily functioning as measured on the Top Executive Functioning Difficulties.
Time frame: After 9 weeks of parental UOT Training
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.
3 secondary outcomes
Change from baseline in child executive function using the Behavior Rating of Executive Function-II (BRIEF-II).
Time frame: After 9 weeks of parental UOT Training
Change from baseline in parental self-efficacy on the Parenting Sense of Competence Scale.
Time frame: After 9 weeks of parental UOT Training
Change from Baseline in parental perceptions of caregiving as measured on the Caregiver Questionnaire
Time frame: After 9 weeks of parental UOT Training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Childress, PhD principal investigator
3C Institute
Lauren Kenworthy, PhD principal investigator
Children's National Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-Unstuck and Unstuck and On Target in people with Autistic Disorder, run by 3-C Institute for Social Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in ratings of top three child EF difficulties interference with daily functioning as measured on the Top Executive Functioning Difficulties. (time frame: After 9 weeks of parental UOT Training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.