NonSub Change - Pretest and IRB updates

To: Kelsi Feltz

Office of Information and Regulatory Affairs (OIRA)

Office of Management and Budget (OMB)

From: Calonie Gray, Kelly Jedd McKenzie

Office of Planning, Research and Evaluation (OPRE)

Administration for Children and Families (ACF)

Date: March 6, 2024

Subject: NonSubstantive Change Request – Replication of Recovery and Reunification Interventions for Families-Impact Study (R3-Impact) (OMB #0970-0616)

This memo requests approval of nonsubstantive changes to the approved information collection, Replication of Recovery and Reunification Interventions for Families-Impact Study (R3-Impact) (OMB #0970-0616).

Background

The Office of Planning, Research, and Evaluation (OPRE) is conducting the R3-Impact study which includes an impact and implementation evaluation of the Parent Mentor Program (PMP). OMB initially approved data collection instruments for this project on September 21, 2023. Since approval, the R3-Impact team has continued planning evaluation procedures with study sites, conducted a pretest of the parent baseline survey, and undergone a full Institutional Review Board (IRB) review. IRB approval for the PMP impact evaluation was received on February 16, 2024. These efforts have resulted in some proposed nonsubstantive changes.

Overview of Requested Changes

The current request is to seek approval for edits to already-approved instruments for the impact evaluation based on feedback from sites, pretest participants, and the IRB. The requested changes will not result in any changes in burden assumptions. An overview of the requested edits to approved instruments and supporting statements is included below.

1. Supporting Statement A

   1. Updated study enrollment timeline (pg. 2)

   2. Clarified response option modes for Collecting Updated Contact Information (pg. 7)

2. Supporting Statement B

   1. Updated informed consent procedures including who can collect consent and waiver of written consent (pg. 6)

   2. Updated study registration registry (pg.9)

3. Baseline Survey (Instrument 1)

   1. Added final IRB approved introduction and closing text including information about the voluntary nature of the survey, length of the survey, and tokens of appreciation (pg. 3)

   2. Updated verification section for clarity (pg. 4)

   3. Edited question instructions and response options in several places for clarity, relevance to population, consistency, and to ensure quality data collection

   4. Made edits to interviewer instructions and programming instructions throughout the survey, where needed, to ensure quality data collection

   5. Identified which sections can be self-administered (Depressive symptoms pg. 10, Social Supports pg. 11, Parenting Stress pg. 12; Substance Use pg. 21-28; Personal History/Circumstances pgs. 33-35) by adding additional text and programming instructions

   6. Modified household composition questions (pg. 6). Removed the question that verified whether the number of adults in the household included themselves (HOUS-4) and added supplemental question on number of children a participant has (HOUS-5) for relevance to the study population.

   7. Re-ordered questions on ever used alcohol (SUDAL-1) or ever used drugs (SUDOTDA-A1) to be at the beginning of the substance use section for ease of skip patterns (pg. 21)

   8. Added supplemental question about use of alcohol (SUDAL-1.b1), to determine if participant has ever used alcohol in past six months but not used in last 30 days (pg. 21) to improve data quality.

   9. Re-ordered list of substances in the other drugs type/frequency questions (SUDOT-1—SUDOT-4). Reduced list by one by combining barbiturates with sedatives (pgs. 25-26)

   10. Added income level and mental health as response options for reasons for discrimination (PHDS-FU-1), pg. 37.

4. Contact Form (Instrument 2)

   1. Edited language to include the public facing study name and contact information for the study team

   2. Added language to clarify the available methods to respond

   3. Added language to clarify privacy exceptions and mandated reporting requirements

   4. Edited language for clarity and alignment to other study materials

5. Participant informed consent form – Impact Evaluation (Appendix B)

• Edited language to include the public facing study name and contact information for the study team

• Added study logo

• Edited language in several places for relevance to population, clarity, and readability (includes reordering several sentences)

• Formatting changes (e.g., adding bullets) to improve readability

• Added a brief summary about the Parent Mentor Program

• Added information about the study embargo for the control group

• Separated out additional study activities for parents in the treatment group and added a line about the potential parent interview (this will have additional and separate consent as indicated in Appendix C of the initial submission)

• Removed line about collection of Medicaid records as the PMP evaluation will not collect any Medicaid substance use treatment services records

• Added more detailed information about the study’s safety plan and contacting outside authorities including mandated child welfare reporting

• Updated record keeping of consent given IRB waiver of written consent

6. Crosswalk of Survey Items to Research Questions (Appendix D)

   1. Updated questionnaire numbers due to reorganization of instrument

Time Sensitivities

We request OMB’s review by mid-March 2024 in order to begin using the updated instruments and finalize preparation for the launch of study enrollment including training staff on the use of these instruments. Staff training is planned for the first three weeks of April, and study enrollment is slated to begin the week of April 22^nd.