New Skills - No Scores Research Study (NCT04254666) | Clinical Trial Compass
CompletedNot Applicable
New Skills - No Scores Research Study
United States6 participantsStarted 2020-01-24
Plain-language summary
The purpose of this study is to test the feasibility of a physical literacy and food literacy intervention for children with Intellectual Disabilities ages 12-16 years. The Investigators plan to assess preliminary efficacy of the intervention for increasing 1) physical literacy including movement skills, physical self-concept, and desire to participate in physical activity and 2) food literacy including knowledge around making healthy food choices, basic food preparation skills, and engaging in healthy eating behavior.
Who can participate
Age range
12 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* measured IQ and adaptive functioning scores of ≤75 as measured by the Kaufman Brief Intelligence Test-2 (KBIT-2) and Vineland Adaptive Behavior Scales-III (VABS-III). A score \> 75 for participants that do not have a syndrome that is associated with ID will be exclusionary. However, participants with such syndromes (e.g., Down syndrome) may have scores above this cut-point but are still classified as having an intellectual disability and thus will qualify for the study.
* Participants must be ambulatory and in sufficiently good health to engage in moderate-to-vigorous physical activity
* able to communicate verbally in English, follow simple instructions, and provide assent.
* approval from the participants' primary care physician and specialists (as necessary) will be required for participation.
Exclusion Criteria:
* uncontrolled medical or significant psychiatric condition
* insulin-dependent diabetes
* physical/orthopedic impairment that would preclude participation in physical activity
* legally blind or deaf
* habitual problem behaviors such as aggression, noncompliance, or leaving an activity area.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Motivation and Confidence in Physical Activity
Timeframe: Baseline and Post intervention (within 1 month)
2
Movement/Motor Skills
Timeframe: Baseline and Post intervention (within 1 month)
3
Desire to Participate in Physical Activity
Timeframe: Baseline and Post intervention (within 1 month)
4
Healthy Food Knowledge.
Timeframe: Baseline and Post intervention (within 1 month)
5
Foods Participant is Willing to Eat
Timeframe: Baseline and Post intervention (within 1 month)
6
Food Categorization
Timeframe: Baseline and Post Intervention (within 1 month)