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Adult Broad Learning Experiment (ABLE): Feasibility Study (ABLE)

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ClinicalTrials.gov Identifier: NCT03438136
Recruitment Status : Active, not recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Collaborator:
American Psychological Foundation
Information provided by (Responsible Party):
Rachel Wu, University of California, Riverside

Tracking Information
First Submitted Date  ICMJE January 28, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date February 19, 2018
Actual Study Start Date  ICMJE December 5, 2017
Estimated Primary Completion Date December 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
  • Executive Function [ Time Frame: Pre-test to post-test (15 weeks: Week 1; Week 15) ]
    Measured by NIH EXAMINER battery
  • Broad Learning Adult Questionnaire [ Time Frame: Pre-test to post-test (15 weeks: Week 1; Week 15) ]
    New questionnaire developed by PI
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adult Broad Learning Experiment (ABLE): Feasibility Study
Official Title  ICMJE Adult Broad Learning Experiment (ABLE): Feasibility Study
Brief 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 (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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Basic Science
Condition  ICMJE Cognitive Decline
Intervention  ICMJE Behavioral: 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.
Study Arms  ICMJE
  • Experimental: Intervention arm
    This arm will be enrolled in the intervention.
    Intervention: Behavioral: Adult Broad Learning Experiment (ABLE)
  • No Intervention: No intervention arm
    This arm will be enrolled in a no contact control group.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 15, 2018)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 13, 2019
Estimated Primary Completion Date December 13, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria: n/a

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03438136
Other Study ID Numbers  ICMJE 1320181
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rachel Wu, University of California, Riverside
Study Sponsor  ICMJE University of California, Riverside
Collaborators  ICMJE American Psychological Foundation
Investigators  ICMJE Not Provided
PRS Account University of California, Riverside
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP