SAMHSA, Health and Human Services.
The mission of SAMHSA is to reduce the impact of substance abuse Start Printed Page 33854and mental illness on America's communities. Established in 1992, the Agency was directed by Congress to target effective substance abuse and mental health services to the people most in need and to translate research in these areas more effectively and more rapidly into the general health care system. NREPP is a key public resource SAMHSA has developed to help meet this directive. As of June 2013, approximately 290 interventions developed in the U.S. and abroad have been reviewed and added to the registry. This notice announces NREPP's open submission period for fiscal year 2014, during which program developers may submit a request to have their intervention reviewed. The notice provides information about the documentation that submissions must include to demonstrate that an intervention meets NREPP's minimum requirements; the responsibilities of the Principal during the review process; and the process for submitting materials for review during the open submission period.
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FOR FURTHER INFORMATION CONTACT:
Alyson Essex, Ph.D., MHS, Social Science Analyst, SAMHSA, 1 Choke Cherry Road, Room 2-1002, Rockville, MD 20857, telephone 240-276-0529.
Substance Abuse and Mental Health Services Administration's National Registry of Evidence-Based Programs and Practices (NREPP): Open Submission Period for Fiscal Year 2014
The Substance Abuse and Mental Health Services Administration's (SAMHSA) National Registry of Evidence-based Programs and Practices (NREPP) is a searchable online database of interventions that have been shown to produce significant behavioral outcomes in substance abuse prevention, mental health promotion, or the treatment of mental or substance abuse disorders and that are ready to be implemented by the public. Interventions that are accepted for review by NREPP undergo an independent review process in which (1) up to three studies are assessed and rated for Quality of Research and (2) the intervention's implementation, training, and quality assurance materials and processes are assessed and rated for Readiness for Dissemination. The results of these reviews are published on the NREPP Web site, http://nrepp.samhsa.gov. NREPP is designed as a decision-support tool for providers responsible for selecting and implementing interventions. The acceptance of interventions for review and the inclusion of interventions on the NREPP Web site are not intended to convey endorsement, recommendation, or approval of these interventions by SAMHSA. Policymakers and funders, in particular, are discouraged from requiring contracted providers or grantees to use specific interventions based on their inclusion in the registry.
This notice announces the next open submission period during which SAMHSA will consider and accept requests for review, describes the requirements for submission, and provides information about the review process.
Open Submission Period
SAMHSA has established a 2-month period for receipt of requests for NREPP reviews for fiscal year 2014 that will begin January 2, 2014, and end February 28, 2014. Submitters are encouraged to visit the NREPP Web site to learn more about the review process. The Reviews & Submissions page (http://nrepp.samhsa.gov/Reviews.aspx) provides an overview of the steps involved in reviews, the rating criteria used to assess Quality of Research and Readiness for Dissemination, and how reviewers are selected and trained. Examples of published intervention summaries, the end product of each review, can be viewed at http://nrepp.samhsa.gov/ViewAll.aspx.
For an intervention to be eligible for review, the submitter must provide written documentation that demonstrates the following minimum requirements have been met:
1. The intervention has produced one or more positive behavioral outcomes (p≤.05) in mental health or substance abuse among individuals, communities, or populations. Significant differences between groups over time must be demonstrated for each outcome.
2. Evidence of the positive behavioral outcome(s) has been demonstrated in at least one study using an experimental or quasi-experimental design. Experimental designs include random assignment of participants, a control or comparison group in addition to the intervention group, and pre- and posttest assessments. Quasi-experimental designs include a control or comparison group and pre-and posttest assessments but do not use random assignment. Studies with single-group, pretest/posttest designs do not meet this requirement.
3. The results of these studies have been published in a peer-reviewed journal or other professional publication (e.g., a book volume) or documented in a comprehensive evaluation report. Comprehensive evaluation reports must include the following sections or their equivalent: a review of the literature, theoretical framework, purpose, methodology, findings/results (with statistical analysis and p values for significant outcomes), discussion, and conclusions. Information must be included to enable rating of the six Quality of Research criteria: (1) Reliability of measures, (2) validity of measures, (3) intervention fidelity, (4) missing data and attrition, (5) potential confounding variables, and (6) appropriateness of analysis.
4. Implementation materials, training and support resources, and quality assurance procedures have been developed and are ready for use by the public.
The documentation demonstrating these minimum requirements must be provided at the time of submission. Table 1 lists examples of appropriate supporting documentation.
Table 1—Documentation for Demonstrating Satisfaction of Minimum Requirements
|Quality of Research:|
|1. Intervention has produced one or more positive behavioral outcomes (p≤.05) in mental health or substance abuse among individuals, communities, or populations. Significant differences between groups over time must be demonstrated for each outcome||A list of significant behavioral outcomes that includes supporting citations (document/page number) for the location of each outcome showing p values and|
|2. Evidence of these outcomes has been demonstrated in at least one study using an experimental or quasi-experimental design||A full-text copy of each article/report cited in the list of outcomes. Other research articles, published or unpublished evaluation reports, grant final reports, and replication studies may be submitted as additional supporting documentation.|
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|3. Results of these studies have been published in a peer-reviewed journal or other professional publication (e.g. book volume) or documented in a comprehensive evaluation report||Documentation must be provided to enable the rating of the six Quality of Research criteria (i.e., reliability of measures, validity of measures, intervention fidelity, missing data and attrition, potential confounding variables, and appropriateness of analysis).|
| ||NOTE: Abstracts or URLs to partial articles are regarded as incomplete documentation and will not be considered. Meta-analyses will not be considered for review.|
|Readiness for Dissemination:|
|4. Implementation materials, training and support resources, and quality assurance procedures have been developed and are ready for use by the public||A brief narrative description and list of available materials, resources, and systems to support implementation (e.g., treatment manuals, information for administrators, tested training curricula, mechanisms for ongoing supervision and consultation, protocols for gathering process and outcome data, ongoing monitoring of intervention fidelity, processes for gathering feedback) and|
| ||A brief description of the method through which new implementation sites acquire the above materials.|
The following types of interventions are not eligible for review:
1. Stand-alone pharmacologic treatments. The evidence base for pharmacologic treatments is reviewed and approved through the U.S. Food and Drug Administration (FDA). FDA-approved pharmacotherapy interventions (on-label use) are considered for NREPP review only when combined with one or more behavioral or psychosocial treatments.
2. Interventions that have been developed or evaluated with funds or other support, either partially or wholly, from organizations whose goals or activities are determined to be inconsistent with SAMHSA's mission.
Acceptance of Interventions
Submissions that meet the four minimum requirements (excluding ineligible interventions previously noted) will be considered for review. The number of interventions selected by SAMHSA for review and the timing of these reviews depend on the availability of funds and will be determined at SAMHSA's discretion. Interventions not selected for review during this fiscal year may be resubmitted during a future open submission period.
Role of the Principal
Before an intervention can be formally accepted for review and added to the Accepted for Review list on the NREPP Web site, there must be agreement upon and designation by the submitting organization of a Principal to oversee the review. The designation of the Principal role must be agreed to by those who have had a major role in the development and/or evaluation of the intervention. The Principal is typically a principal investigator who has conducted research on the intervention, a program developer who has collaborated with an evaluator of the intervention, or an official of the organization requesting the review.
The Principal is responsible for ensuring provision of all materials and documentation to be used in the review. This includes full-text copies of articles and reports that provide evidence of significant outcomes as well as copies of dissemination materials in the format they are provided to the public (e.g., hard copies or electronic versions of manuals, training presentations, tools, quality assurance protocols, URLs for interactive Web-based resources). The Principal is required to participate in a kickoff call at the commencement of review and may be asked to answer questions about the intervention, the articles, or the intervention materials for clarification at various points throughout the review process.
At the end of the review, the Principal receives a draft intervention summary presenting the results of the review and is asked to provide corrections and comments. The results of NREPP reviews are considered public, and after having the opportunity to comment on the summary, the Principal is expected to authorize publication of the summary on the NREPP Web site. If the Principal does not provide that authorization, the intervention will be identified on the NREPP Web site as having undergone review, with a statement indicating the Principal did not authorize publication of the summary.
Instructions for Submitting an Intervention
Submissions must include (1) a letter formally requesting a review and (2) documentation demonstrating that the minimum requirements described above have been met. NREPP prefers letters of interest and supporting materials to be submitted electronically using an online submission tool that will be made available during the open submission period. On January 2, 2014, NREPP will post a link to the online submission tool and instructions for how to obtain a username and password at http://www.nrepp.samhsa.gov/ReviewSubmission.aspx. Please call 1-866-436-7377 for technical assistance on the electronic submission process or to arrange for submission by hard copy or fax if electronic submission is not possible. To be eligible for consideration, a complete submission including both the letter of request and supporting documents must be received no later than 11:59 p.m. E.S.T. on February 28, 2014; materials received before January 2, 2014, will be disregarded.
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FOR FURTHER INFORMATION CONTACT:
Individuals who have specific questions about the information contained in this notice may write to NREPP staff at email@example.com or call 1-866-436-7377.
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[FR Doc. 2013-13223 Filed 6-4-13; 8:45 am]
BILLING CODE 4162-20-P