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Research Methods Section

The research methods section for an intervention study, particularly at the efficacy or effectiveness trial phases, must contain sufficient detail concerning every aspect of the design. Subsections and their organization will vary depending upon the nature and scope of the study and design and the requirements of the funding agency, but typically include eight basic sections: (a) brief overview of research design; (b) general procedures including data collection; (c) sample description, recruitment procedures, eligibility and ineligibility criteria, expected attrition; (d) retention considerations; (e) description of measures and specific treatment outcomes; (f) description of interventions; (g) statistical analytic considerations and plan of analysis for each aim including how clinical significance will be established; and (h) time line, project organization, and quality control procedures.

Describing the Intervention

As the heart of the matter is the intervention, describing it accurately and clearly in a proposal is of utmost importance. Reviewers must understand the importance of the intervention for addressing an identified problem area, why the intervention may be effective for a particular target population, and its potential benefits.

We recommend that six aspects of the intervention itself be described in proposals. As summarized in Table 23.2, these include: (a) the theory base or conceptual frameworks informing the intervention (see Chapter 4); (b) its delivery characteristics including dosage, mode of delivery, location of delivery, and what constitutes

TABLE 23.2 Elements to Include in a Description of an Intervention

Elements Description

Theory base or conceptual framework

Describe how one or more theories or frameworks specifically inform the intervention. Use the theory to explain what is being targeted by the intervention (e.g., behavior, social relationships, cognition, environment) and why the intervention should achieve its desired outcomes.

Delivery

characteristics

This includes dose, intensity, duration, setting, and form of intervention delivery (e.g., Web, telephone, face-to-face or technology).

Flow of intervention

Describe the specific activities, composition of sessions or flow. If possible, include a brief description of each session.

Interventionists

Describe skill set and background of the persons who will be delivering the intervention.

Training

Describe length of time and extent of training needed for interventionists and certification process.

Fidelity

Describe a fidelity plan including what enhancements will be used to assure implementation integrity and measures used.

Implementation

potential

Describe potential context for delivery, organizational framework, future potential payment mechanism(s) for sustainability, and cost of intervention (if known).

a “completer” (see Chapter 5); (c) the intervention flow or what transpires in each treatment session (see Chapter 3); (d) the skill set and background of individuals who will provide the intervention (see Chapter 22); (e) the content of and approach to training interventionists (see Chapter 22); and (f) a treatment fidelity plan (see Chapter 12). The extent to which each of these elements is described will depend upon the phase of development of the intervention. For example, in proposing a pilot study (Phase I or II) to evaluate dosing, one might not have an extensive fidelity plan; whereas in an efficacy trial (Phase III), this would need to be fully explicated.

There is no right or wrong way to describe an intervention in a grant proposal. The goal is to enable reviewers to have a concrete understanding of the intervention and its importance upon reading an application. Providing a case example that summarizes the intervention components and expected benefits and using a table to outline the specific steps of the intervention or describe the activities of each treatment session are potentially useful illustrative tools. One must weigh the relative merits of any one of these approaches or use of graphics given page limitations to determine the best way to convey a compelling story about the intervention.

 
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