If we knew what it was we were doing, it would not be called research, would it?

—Albert Einstein

Behavioral intervention research is burgeoning and gaining recognition as playing a necessary and critical role in the development of strategies to address today’s complex social and health care issues. Behavioral interventions address a wide range of issues and populations and can target individuals, communities, organizations, or the social, physical, or policy environments. Interventions can take many forms and may involve counseling, training, psychotherapy, education, skill building, stress management techniques, or some combination of activities. They may also target different aspects of behavior, such as coping skills, knowledge, self-management, or involve modifications to the physical and/or social environment. Many intervention programs are multifaceted and involve multiple components, objectives, and activities. Interventions also evolve and change throughout the phases of the pipeline over time, as new knowledge is gained from testing and from effective treatment approaches and methodological approaches. However, irrespective of the target population or the form of the intervention, behavioral intervention research is directed at gathering evidence regarding the impact of a program or protocol on an outcome(s) that is relevant to the problem of interest.

As discussed in Chapter 1, this type of research is complex, challenging, and costly. The researcher is faced with many decisions at all phases of the pipeline. As we discuss in this chapter, these decisions concern the content of the intervention, mode of treatment delivery, the duration of the intervention, and training and monitoring study interventionists. For example, if a researcher decides (after an extensive review of the literature) that he or she is interested in developing an intervention to alleviate the emotional distress of family caregivers, decisions will need to be made regarding the characteristics of the targeted sample (e.g., spouse vs. nonspouse, dementia caregiver vs. cancer caregiver); the aspect of caregiving or the care recipient that will be targeted (e.g., emotional well-being, problem behaviors, physical health, pain); sample size, the content, and duration of the intervention and how it will be delivered (e.g., face-to-face, computer, telephone); and how the impact of the intervention will be assessed. Clearly, this represents only a handful of issues that must be resolved.

Importantly, as discussed in Chapter 1, decisions regarding the characteristics of an intervention and an intervention trial cannot be made in a vacuum. Interventions occur within a context that includes multiple interacting levels such as the individual, the setting in which the intervention will be delivered, formal and informal networks and social support systems, the community, and the policy environment. All of these levels and the potential interactions among them need to be considered in the design of an intervention study. For example, if an intervention involves using a computer for treatment delivery, then issues such as the availability of the technology, the technology skills of the target population, and technology requirements (e.g., Internet/broadband access) will need to be addressed (see Chapter 7).

Our goal in this chapter is to provide an overview of the key factors that need to be considered in the design of the behavioral intervention itself. Our focus is specifically on the delivery characteristics of the intervention program (e.g., intervention content, dosage, delivery mode). Our objective is to highlight the multitude of factors that need to be considered when designing the delivery characteristics of a behavioral intervention study. Basically, this entails making decisions about what should be delivered, how it should be delivered and by whom, at what intensity, and for how long. Other decision points relate to materials, equipment, cost, and feasibility. Our intent is to provide a “roadmap” to guide the intervention protocol design process (Table 5.1). Other topics related to the design of an intervention study, such as sampling and ethical considerations and experimental methodologies, are covered in more depth in other chapters.

It is important to note that some of the topics related to designing delivery characteristics of an intervention (e.g., staff training) may have varying importance at various phases along the pipeline. However, even though some issues may not be relevant until the later phases, it is still important to understand what they are and consider them early on in the development of an intervention. Decisions that are made in the intervention development phases have a significant influence on the later phases of the pipeline. For example, the fidelity of an intervention program can be compromised if consideration is not given to staff training or protocols for monitoring treatment fidelity in the beginning of the intervention development process (see Chapter 12 for a discussion of fidelity).

Delivery characteristics are the backbone of an intervention and have a profound influence on the feasibility, timeline, and cost of a trial; the evidence regarding the impact of the intervention; and the likelihood that the intervention will be implemented on a broad scale. The challenge for the intervention researcher is to design intervention programs and research protocols that meet the standards for rigorous evaluation; address the needs and preferences of the targeted population; are effective with respect to outcomes; are feasible and can be replicated; and can ultimately be implemented in community and clinical settings. Purposely building in adaptability in the delivery characteristics is key to meeting these challenges as we have learned from moving interventions along the pipeline (e.g., flexible scheduling or dosing). Intervention research is an iterative process (see Chapter 2) where the outcomes and experiences of each phase inform the next phase of the pipeline; this is the case for every aspect of intervention work including the design of the delivery characteristics of an intervention, which is our focus here.

TABLE 5.1 Considerations in the Design of Delivery Characteristics

Delivery Characteristic


Treatment content

  • ? Theory/prior findings relevant to the content
  • ? Personnel involved in content decisions
  • ? Content to be delivered
  • ? Order or sequence of content
  • ? Number of components
  • ? Degree of flexibility/adaptability
  • ? Feasibility issues (e.g., cost)
  • ? Equipment requirements
  • ? Replicability
  • ? Participant burden
  • ? Safety
  • ? Protocols for informed consent and adverse event monitoring and reporting
  • ? Treatment manual of operation

Treatment dosage and duration

  • ? Duration of treatment
  • ? Amount of treatment
  • ? Strategy for measurement of dose
  • ? Feasibility
  • ? Participant burden
  • ? Criteria for intervention "completion"
  • ? Delivery schedule
  • ? Flexibility in schedule
  • ? Booster sessions
  • ? Protocol for tracking content

Delivery modality

  • ? Format of delivery (e.g., face-to-face, telephone, Internet)
  • ? Multimodal/single modality
  • ? Use of technology
  • ? Cost
  • ? Technical requirements
  • ? Skill and training requirements (participant and interventionist)

Delivery setting

  • ? Choice of setting (e.g., home vs. clinic)
  • ? Logistic requirements
  • ? Generalizability/external validity
  • ? Threats to internal validity
  • ? Single site versus multisite

Delivery approach

  • ? Prescriptive versus tailoring
  • ? Cultural adaptations
  • ? Aspects of the intervention that can be amenable to tailoring
  • ? Personnel involved in tailoring decisions
  • ? Criteria for tailoring
  • ? Protocols for documenting adaptations/tailoring

Staffing requirements

  • ? Size and nature of team (e.g., recruitment, coordinator, assessors, interventionists)
  • ? Skill level requirement for team
  • ? Characteristics (e.g., age, gender, language, culture/ ethnicity)
  • ? Training protocols and criteria

TABLE 5.1 Considerations in the Design of Delivery Characteristics (Continued)

Delivery Characteristic


  • ? Strategies for team building
  • ? Protocols for communication
  • ? Protocols for meetings
  • ? Plan for monitoring and assessment
  • ? Safety protocols
  • ? Training for ethical conduct of research; resolution for adverse events
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