Appendix B - Individual Assignment Tool Instructions

Instructions for the Sample Progress Reporting Tool for Individual Assignment

The information collected in the tool will be used for internal purposes to (1) assess sample enrollment and compare actual sample sizes to the target sample sizes on which power calculations were based, and (2) for randomized controlled trials (RCTs), assess the likelihood that the final analytic sample for key follow-up time periods might exceed the thresholds for overall or differential attrition specified by the Standards of Rigor and the Teen Pregnancy Prevention Evidence Review. This tool will also help the LES team to identify any specific areas where we can provide additional evaluation support to ensure you have an adequate sample size and minimal attrition to meet the Standards of Rigor.

A note on follow-up periods:

The PREIS Notice of Funding Opportunity defines short-term follow-up as up to 6 months post intervention and long-term follow-up as 9 months or more post intervention. If you have more than one follow-up period during one of these timeframes, please work with your LES liaison to select the follow-up period that is most meaningful for your evaluation to include in this tool.

To complete the INDIVIDUAL ASSIGNMENT form, enter information into the YELLOW cells. For instructions on what to enter, you can review the information in this document, or click on a yellow cell and instructions will pop up. GREEN cells will automatically populate based on the information you enter in the yellow cells. (Note: for multi-arm studies, this form should be completed separately for each treatment/control pairing.) For additional support, please contact your LES liaison or PREPLES@abtglobal.com.

Instructions for each data entry box

Box 1

Sample enrollment and data collection through this date

• Please indicate the date through which sample enrollment and data collection are reflected in this form.

Box 2

# Youth enrolled in study to date

• Please indicate the number of eligible youth for whom you have received consent/assent and who were assigned to the study treatment or control/comparison groups.

Box 3a

# Assigned to treatment

• Please indicate the number of youth assigned to the treatment group.

Box 3b

# Assigned to control/comparison

• Please indicate the number of youth assigned to the control/comparison group.

Box 4a

# Completed baseline survey

• Please indicate the number of enrolled youth in the treatment group who completed all or part of the baseline survey.

Box 4b

# Completed baseline survey

• Please indicate the number of enrolled youth in the control/comparison group who completed all or part of the baseline survey.

Box 5a

# For whom short-term follow up has closed

• Please indicate the number of youth in the treatment group for whom the short-term follow up survey window has closed (i.e., the number of youth who should have completed the short-term follow up survey) as of the date of this form. While the study is in progress, some youth may not have had the opportunity to contribute data for the short-term follow up if they have not yet reached the short-term follow up period. For example, youth who have not completed the program would not have had the opportunity to contribute any follow up data. Therefore, these youth should not be included in these counts.

# Completed short-term follow up survey

• Please indicate the number of youth from the treatment group that provided short-term follow up data in all short-term follow up windows that have closed as of the date of this form.

Retention rate (automatically calculated)

• This percentage is (# Completed short-term follow up survey) divided by (# For whom short-term follow up has closed) multiplied by 100. (If your study obtained consent after random assignment, please consult your LES liaison about calculating attrition.)

Box 5b

# For whom short-term follow up has closed

• Please indicate the number of youth in the control/comparison group for whom the short-term follow up survey window has closed (i.e., the number of youth who should have completed the short-term follow up survey) as of the date of this form. While the study is in progress, some youth may not have had the opportunity to contribute data for the short-term follow up if they have not yet reached the short-term follow up period. For example, youth who have not completed the program would not have had the opportunity to contribute any follow up data. Therefore, these youth should not be included in these counts.

# Completed short-term follow up survey

• Please indicate the number of youth from the control/comparison group that provided short-term follow up data in all short-term follow up windows that have closed as of the date of this form.

Retention rate (automatically calculated)

• This percentage is (# Completed short-term follow up survey) divided by (# For whom short-term follow up has closed) multiplied by 100. (If your study obtained consent after random assignment, please consult your LES liaison about calculating attrition.)

Box 6a

# For whom long-term follow up has closed

• Please indicate the number of youth in the treatment group for whom the long-term follow up survey window has closed (i.e., the number of youth who should have completed the long-term follow up survey) as of the date of this form. While the study is in progress, some youth may not have had the opportunity to contribute data for the long-term follow up if they have not yet reached the long-term follow up period. For example, youth who have not completed the program would not have had the opportunity to contribute any follow up data. Therefore, these youth should not be included in these counts.

# Completed long-term follow up survey

• Please indicate the number of youth from the treatment group that provided long-term follow up data in all long-term follow up windows that have closed as of the date of this form.

Retention rate (automatically calculated)

• This percentage is (# Completed long-term follow up survey) divided by (# For whom long-term follow up has closed) multiplied by 100. (If your study obtained consent after random assignment, please consult your LES liaison about calculating attrition.)

Box 6b

# For whom long-term follow up has closed

• Please indicate the number of youth in the control/comparison group for whom the long-term follow up survey window has closed (i.e., the number of youth who should have completed the long-term follow up survey) as of the date of this form. While the study is in progress, some youth may not have had the opportunity to contribute data for the long-term follow up if they have not yet reached the long-term follow up period. For example, youth who have not completed the program would not have had the opportunity to contribute any follow up data. Therefore, these youth should not be included in these counts.

# Completed long-term follow up survey

• Please indicate the number of youth from the control/comparison group that provided long-term follow up data in all long-term follow up windows that have closed as of the date of this form.

Retention rate (automatically calculated)

• This percentage is (# Completed long-term follow up survey) divided by (# For whom long-term follow up has closed) multiplied by 100. (If your study obtained consent after random assignment, please consult your LES liaison about calculating attrition.)

Progress Towards Goal - Box 7

Target # youth from evaluation plan

• Please indicate the target number of youth needed for the evaluation (from your approved evaluation plan).

# Youth enrolled in study to date (from above)

• This is the same number you entered in Box 2.

# Needed to recruit (automatically calculated)

• This number is (# Target youth from evaluation plan) minus (# Youth enrolled in study to date), or zero if the target has been surpassed.