Cognitive DeclineABLENCT03438136
Adult Broad Learning Experiment (ABLE): Feasibility Study
A study testing Adult Broad Learning Experiment (ABLE) in people with Cognitive Decline, run by University of California, Riverside at 1 site in United States.
Trial summary
This study evaluates the feasibility of enrolling and retaining older adults in a 15-week intervention that will implement six factors from early childhood experiences: individualized scaffolding (having a responsive teacher), forgiving environment (allowing the learner to make and learn from mistakes), growth mindset… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- Adult Broad Learning Experiment (ABLE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2017to 13 Dec 2019
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 55 years of age or older
- Fluent in English
- Have not been diagnosed with a cognitive condition (e.g., Mild Cognitive Impairment, Alzheimer's, and Dementia)
- Currently not experiencing a mental health disorder (e.g., anxiety, depression, Schizophrenia)
- Have normal eye vision or corrected-to-normal eye vision
- Not proficient in any of the three skills that will be taught during the intervention. Proficiency of skills will be determined by participants' self-report of their experience with each skill. Only potential participants who self-report having less than one or more years of experience with any of the three skills in the past 10 years or as having less than 5 years of experience more than 50 years ago will be considered as being "unfamiliar" with that skill (or skills) and will be qualified to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Riverside
Riverside, California, 92521
About this study
This study evaluates the feasibility of enrolling and retaining older adults in a 15-week intervention that will implement six factors from early childhood experiences: individualized scaffolding (having a responsive teacher), forgiving environment (allowing the learner to make and learn from mistakes), growth mindset (believing that abilities can develop with effort), open-minded learning (exploring new experiences), serious commitment to learning (adopting a "learning" lifestyle), and learning multiple skills simultaneously. These six factors will be implemented via concurrent classes at the UCR Extension center (OSHER Lifelong Learning Institute).
- Conditions
- Cognitive Decline
- Being tested
- Adult Broad Learning Experiment (ABLE)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult Broad Learning Experiment (ABLE)Behavioural
This intervention implements six factors from early childhood experiences: individualized scaffolding (having a responsive teacher), forgiving environment (allowing the learner to make and learn from mistakes), growth mindset (believing that abilities can develop with effort), open-minded learning (exploring new experiences), serious commitment to learning (adopting a "learning" lifestyle), and learning multiple skills simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | This arm will be enrolled in the intervention. Receives: Behavioral: Adult Broad Learning Experiment (ABLE) |
| No intervention arm | No intervention | This arm will be enrolled in a no contact control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening-to-enrollment ratio
Number of participants we screen relative to the number of participants who enroll
Measured: Beginning of the intervention (Week 1)
Intervention adherence
Amount of homework hours logged and class attendance
Measured: Throughout the intervention (15 weeks)
Enjoyment of intervention activities
Assessed via a brief questionnaire of 4 questions created by our research team. Range: 4-24, summed across 4 questions.
Measured: Week 15
Secondary outcomes (2)
Executive Function
Measured by NIH EXAMINER battery
Measured: Pre-test to post-test (15 weeks: Week 1; Week 15)
Broad Learning Adult Questionnaire
New questionnaire developed by PI
Measured: Pre-test to post-test (15 weeks: Week 1; Week 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start5 Dec 2017
- Primary completion13 Dec 2018 (estimated)
- Study completion13 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Half of the participants will participate in the intervention, and the other half will be assigned to a no contact control group.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Riverside
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Foundation
- Responsible party
- Principal investigator, Rachel Wu, University of California, Riverside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438136
- Sponsor's protocol ID
- 1320181
- Acronym
- ABLE
- Status last verified
- Feb 2018
- First submitted
- 28 Jan 2018
- Last updated
- 19 Feb 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 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adult Broad Learning Experiment (ABLE): Feasibility Study
- ClinicalTrials.gov ID
- NCT03438136
- Acronym / sponsor ID
- ABLE / 1320181
- Conditions
- Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of California, RiversideUniversity, hospital or other
- Collaborators
- American Psychological Foundation
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 13 Dec 2018 (estimated)
- Study completion
- 13 Dec 2019 (estimated)
- First posted
- 19 Feb 2018 (actual)
- 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.
This study evaluates the feasibility of enrolling and retaining older adults in a 15-week intervention that will implement six factors from early childhood experiences: individualized scaffolding (having a responsive teacher), forgiving environment (allowing the learner to make and learn from mistakes), growth mindset (believing that abilities can develop with effort), open-minded learning (exploring new experiences), serious commitment to learning (adopting a "learning" lifestyle), and learning multiple skills simultaneously. These six factors will be implemented via concurrent classes at the UCR Extension center (OSHER Lifelong Learning Institute).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Half of the participants will participate in the intervention, and the other half will be assigned to a no contact control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Adult Broad Learning Experiment (ABLE)This arm will be enrolled in the intervention. |
| No intervention arm | No intervention | –This arm will be enrolled in a no contact control group. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 55 years of age or older
- Fluent in English
- Have not been diagnosed with a cognitive condition (e.g., Mild Cognitive Impairment, Alzheimer's, and Dementia)
- Currently not experiencing a mental health disorder (e.g., anxiety, depression, Schizophrenia)
- Have normal eye vision or corrected-to-normal eye vision
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Adult Broad Learning Experiment (ABLE)This intervention implements six factors from early childhood experiences: individualized scaffolding (having a responsive teacher), forgiving environment (allowing the learner to make and learn from mistakes), growth mindset (believing that abilities can develop with effort), open-minded learning (exploring new experiences), serious commitment to learning (adopting a "learning" lifestyle), and learning multiple skills simultaneously. | Behavioural | Intervention arm |
Primary outcome
Screening-to-enrollment ratio
Time frame: Beginning of the intervention (Week 1)
Number of participants we screen relative to the number of participants who enroll
Intervention adherence
Time frame: Throughout the intervention (15 weeks)
Amount of homework hours logged and class attendance
Enjoyment of intervention activities
Time frame: Week 15
Assessed via a brief questionnaire of 4 questions created by our research team. Range: 4-24, summed across 4 questions.
2 secondary outcomes
Executive Function
Time frame: Pre-test to post-test (15 weeks: Week 1; Week 15)
Broad Learning Adult Questionnaire
Time frame: Pre-test to post-test (15 weeks: Week 1; Week 15)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adult Broad Learning Experiment (ABLE) in people with Cognitive Decline, run by University of California, Riverside at 1 site 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 6 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Screening-to-enrollment ratio (time frame: Beginning of the intervention (Week 1)). The study lists 3 primary outcomes in all. 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 19 Feb 2018.