The purpose of this study was to pilot a cognitive behavioral treatment protocol for adolescents with co-occurring alcohol use disorder and suicidality, examine its association with symptomatic improvement, and determine its feasibility and acceptability. Treatment consisted of a 6 month acute treatment phase, 3 month maintenance phase, and a 3 month booster phase, as well as case management services. Participants were also permitted to receive concurrent pharmacotherapy. Five of six families completed the protocol. Measures of alcohol use and suicidality were collected at intake, end of acute treatment, and post-treatment. Decreases in alcohol use and suicidal ideation were reported for all participants. Two of the five participants, both with a prior history of suicide attempts, re-attempted during the course of the protocol. Both were maintained in the study and improved over the subsequent portion of the treatment. A high retention rate, strong therapeutic alliance ratings, and low perceived treatment obstacles provide support for the feasibility and acceptability of this intervention. Preliminary results suggest that integrated outpatient cognitive behavioral treatment for alcohol abusing suicidal adolescents is feasible, acceptable, and associated with symptomatic improvement.The odds of experiencing suicidal ideation and/or suicide attempts are approximately 3 times greater among adolescents with alcohol dependence in comparison to those without. 1,2 The odds of completed suicide are 5 to 13 times greater among adolescents diagnosed with an alcohol/illicit substance use disorder. 3 Given the association between alcohol use disorders and suicidality, interventions geared at treating these co-occurring conditions in youth are needed.Randomized studies have not been published to date to examine the efficacy of an integrated intervention for adolescents with co-occurring alcohol use disorder and suicidality. Cognitive behavioral therapy may be particularly effective for this population as it can be used to target cognitive distortions and common skill deficits that underlie adolescent alcohol abuse and suicidality. Only six randomized clinical trials have been published to examine behavioral/ cognitive-behavioral treatment for adolescent substance abuse in general 4-9 and two to examine the efficacy of cognitive behavioral treatment of adolescent suicidality. 10,11
Background/objective Partnerships between healthcare providers and researchers may accelerate the translation of interventions into widespread practice by testing them under real-world conditions, but depend on provider’s willingness to engage with researchers and ability to fully implement an intervention. Aim To understand nursing home leader’s motivations for participating in a research study and perceptions of the process and value. Methods After a feasibility study of tuned lighting in a nursing home, we conducted semi-structured telephone interviews with six facility leaders. Interviews were audio-recorded, transcribed, and independently coded by four investigators. Results Three themes emerged: (1) The importance of the nursing home’s culture and context: the facility had stable leadership, clear processes for prioritizing and implementing new initiatives, and an established interest in the study’s topic. (2) The importance of leader’s belief in the value of the intervention: leaders perceived research generally and the intervention specifically as positively impacting their facility and residents. (3) The importance of ongoing collaboration and flexibility throughout the study period: leaders served as champions to catalyze the project and overcome implementation barriers. Conclusion Nursing home leader’s perspectives about their participation in a feasibility study underscore the importance of establishing strong researcher–provider partnerships, understanding the environment in which the intervention will be implemented, and employing pragmatic methods that allow for flexibility in response to real-world implementation barriers. We recommend eliciting qualitative information to understand the environment in which an intervention will be implemented and to engage opinion leaders who can inform the protocol and champion its success.
Background Agitated and aggressive behaviors (behaviors) are common in nursing home (NH) residents with dementia. Medications commonly used to manage behaviors have dangerous side effects. NHs are adopting non-pharmacological interventions to manage behaviors, despite a lack of effectiveness evidence and an understanding of optimal implementation strategies. We are conducting an adaptive trial to evaluate the effects of personalized music on behaviors. Adaptive trials may increase efficiency and reduce costs associated with traditional RCTs by learning and making modifications to the trial while it is ongoing. Methods We are conducting two consecutive parallel cluster-randomized trials with 54 NHs in each trial (27 treatment, 27 control). Participating NHs were recruited from 4 corporations which differ in size, ownership structure, geography, and residents’ racial composition. After randomization, there were no significant differences between the NHs randomized to each trial with respect to baseline behaviors, number of eligible residents, degree of cognitive impairment, or antipsychotic use. Agitated behavior frequency is assessed via staff interviews (primary outcome), required nursing staff conducted resident assessments (secondary outcome), and direct observations of residents (secondary outcome). Between the two parallel trials, the adaptive design will be used to test alternative implementation strategies, increasingly enroll residents who are likely to benefit from the intervention, and seamlessly conduct a stage III/IV trial. Discussion This adaptive trial allows investigators to estimate the impact of a popular non-pharmaceutical intervention (personalized music) on residents’ behaviors, under pragmatic, real-world conditions testing two implementation strategies. This design has the potential to reduce the research timeline by improving the likelihood of powered results, increasingly enrolling residents most likely to benefit from intervention, sequentially assessing the effectiveness of implementation strategies in the same trial, and creating a statistical model to reduce the future need for onsite data collection. The design may also increase research equity by enrolling and tailoring the intervention to populations otherwise excluded from research. Our design will inform pragmatic testing of other interventions with limited efficacy evidence but widespread stakeholder adoption because of the real-world need for non-pharmaceutical approaches. {2a} Trial registration ClinicalTrials.govNCT03821844. Registered on January 30, 2019. This trial registration meets the World Health Organization (WHO) minimum standard.
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