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FHV: Define what a clinical trial is. Comment on control group
Any trial where we prospectively assign human participants to a "health related interventionā and measure health related outcomes
No control group since not ethical
FHV: Distinguish between a randomized control trial and clinical trialĀ
RCT:
Randomly assigns participants to control or intervention group and does pre + post testing
Random assignment of who got put in which group (equal chance of being put in each group)
Clinical trial:
any trial where we prospectively assign human participants to a health related intervention and measure health related outcomes
FHV: Understand why researchers use prospective registration
Includes:
Inclusion and exclusion criteria
Sample size
Primary outcomes are important so that one canāt rig the study outcomes if it didnāt work out as expected
FHV: Understand the purpose of a flow diagram
Shows the flow of research design from beginning to intervention
Show how many people were interested in trial, how many met inclusion criteria, how many lost, how many finished
Important because:
future researcher can change inclusion criteria based on how many people signed up compared to how many wanted to sign upĀ
find out if an intervention, even if effective, was so hard that it caused lots of attrition or injury
Differentiate between, identify and understand the purpose of non-experimental and experimental research designs
Non-experimental:
Theoretically presumed cause and effect
No intervention
No control group or random assignment
Observational design or correlational design
Observation: How? what?
Correlational: the strength of the association between two variables
Positive or negative direction of relationship
Experimental:
Cause and effect = determinism
manipulate IV(s) to determine if it has an effect on DV(s)
Intervention
Random assignment and control group
Identify cross-sectional and longitudinal research design
Cross-sectional: Only take one measurement, at one time point. It can be for multiple variables
Cannot tell us about change over time
Longitudinal: Repeated measurement of variables over time (weeks, months, years etc)Ā
Identify between-groups and repeated measures designs
Between-groups design:
Separate group for each condition
Participants only provide data once. Only one observationĀ
Repeated measures:Ā
Observations taken from same participants more than onceĀ
IV/Predictor =Ā āTime of observationā
One groupĀ
More than one observationĀ
One treatment
Differentiate between and identify pre-experimental, true experimental and quasi-experimental research design
Pre-experimental:Ā
no random assignmentĀ
They suck because they lack internal validity
Changes in DV cannot be attributed to manipulation of IV
Participants receive treatment of interestĀ
True Experimental:Ā
Random Assignment!
Helps with: history, maturation, testing
Quasi-experimental:Ā
Interested in maximizing external validity; want to approximate real world settingsĀ
No random assignment possibleĀ
ParticipantsĀ āself selectā to one of the groups OR the administrator (coach for ex) decides who receives the treatmentĀ
Identify and describe the strengths and limitations of 3 pre-experimental designsĀ
One shot design: One treatment, one observation afterwards, one group
Group A: T ā O1
Strengths:Ā
InexpensiveĀ
Limitations:Ā
No internal validity because we donāt know what happened to participant before the treatment that could affect the results
One Group Pretest-Posttest study:Ā
Happens with lots of S&C studiesĀ
Goal: try to determine the magnitude of the treatment effectĀ
Repeated measures designĀ
Group A: O1 ā T ā O2
Strengths:
Pre-test helps us compare results pre and post
Limitations:
Cannot attribute any change in performance to the intervention
Posttest Only with Non-Equivalent Groups
N Group A: T ā O1
N Group B: O2
Between-groups design
Strengths:Ā
Has a control group so can compare post test resultsĀ
Limitations:
Groups are NOT randomly formed (intact groups)
Pre-existing differences between the two groups, especially the treatment group, causing it to have higher or lower results
Identify and describe the strengths and limitations of 3 true experimental research designs
True experimental designs have random assignment!
Posttest only Control Group Design
Group A: T, O
Group B: __, O
Strengths:
Random assignment to treatment and control group helps account for selection biasĀ
Limitations:Ā
No pretest
Posttest only Control Group Design with 2 treatments:Ā
Group A: T1, O
Group B: T2, O
Group C: __, (
Strengths:Ā
Determine if one treatment is more effective than another and if it is better than nothing
Limitation:Ā
No pretestĀ
Pretest Posttest Control Group Design:
Group A: O, T, O
Group B: O, __, O
Strengths:Ā
Added pretest to compare measurements of variables. Increases internal validity
Determine how much change is observed inĀ Group A vs Group B
Limitations:Ā
Threat to external validity ā reactive/interactive effects of testingĀ
Hard to generalize finding
Solomon group 4 design:Ā
Group 1: T, O
Group 2: _, O
Group 3: O, T, O
Group 4: O, _, O
Strengths:Ā
Combines post test only and pretest post test designs together
Helps to see if there is a difference post test for those who did a pretest or not.Ā
Helps to account for the reactive/interactive effects of testing (where treatment may not be as effective without the pretest)
Limitations:Ā
Very expensive to repeat treatment.
Identify and describe the strengths and limitations of 3 quasi-experimental research designs
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