Conducting a randomized clinical trial of an psychological intervention for parents/caregivers of children with cancer shortly after diagnosis.

OBJECTIVE: To report acceptability, feasibility, and outcome data from a randomized clinical trial (RCT) of a brief intervention for caregivers of children newly diagnosed with cancer. METHOD: Eighty-one families were randomly assigned following collection of baseline data to Intervention or Treatment as Usual (TAU). Recruitment and retention rates and progression through the protocol were tracked. Measures of state anxiety and posttraumatic stress symptoms served as outcomes. RESULTS: Difficulties enrolling participants included a high percentage of newly diagnosed families failing to meet inclusion criteria (40%) and an unexpectedly low participation rate (23%). However, movement through the protocol was generally completed in a timely manner and those completing the intervention provided positive feedback. Outcome data showed no significant differences between the arms of the RCT. CONCLUSIONS: There are many challenges inherent in conducting a RCT shortly after cancer diagnosis. Consideration of alternative research designs and optimal timing for interventions are essential next steps.

Diagnosis of acute HIV infection in Connecticut.

Acute HIV infection (AHI) is the earliest stage of HIV disease, when plasma HIV viremia, but not HIV antibodies, can be detected. Acute HIV infection often presents as a nonspecific viral syndrome. However, its diagnosis, which enables linkage to early medical care and limits further HIV transmission, is seldom made. We describe the experience of Yale's Center for Interdisciplinary Research on AIDS with AHI diagnosis in Connecticut, as a participating center in the National Institute of Mental Health Multisite AHI Study. We sought to identify AHI cases by clinical referrals and by screening for AHI at two substance abuse care facilities and an STD clinic. We identified one case by referral and one through screening of 590 persons. Screening for AHI is feasible and probably cost effective. Primary care providers should include AHI in the differential diagnosis when patients present with a nonspecific viral syndrome.

Feasibility and preliminary outcomes from a pilot study of a brief psychological intervention for families of children newly diagnosed with cancer.

OBJECTIVE: To report initial feasibility and outcome from a pilot study of a new three-session intervention for caregivers of children newly diagnosed with cancer, Surviving Cancer Competently Intervention Program-Newly Diagnosed (SCCIP-ND). METHOD: Nineteen families (38 caregivers) were randomly assigned to SCCIP-ND or treatment as usual subsequent to learning of their child's illness. The study design included pre- and 2-month postintervention assessments, with state anxiety and posttraumatic stress symptoms as outcomes. Feasibility was based on therapist feedback and supervision, program evaluations, and data from study-tracking procedures. RESULTS: SCCIP-ND appears to be an acceptable intervention that can be used successfully with caregivers over the first few months after diagnosis. Recruitment and retention data document feasibility but also highlight challenges. Preliminary outcome data show changes in the desired direction [e.g., reduced anxiety and parental posttraumatic stress symptoms (PTSS)]. CONCLUSIONS: The pilot data are supportive of the value and challenges of developing evidence-based family interventions in pediatric psychology.