Suicide risk assessment and suicide risk management protocol for the Texas Youth Depression and Suicide Research Network.

Introduction: Suicide prevention research is a national priority, and national guidance includes the development of suicide risk management protocols (SRMPs) for the assessment and management of suicidal ideation and behavior in research trials. Few published studies describe how researchers develop and implement SRMPs or articulate what constitutes an acceptable and effective SRMP. Methods: The Texas Youth Depression and Suicide Research Network (TX-YDSRN) was developed with the goal of evaluating screening and measurement-based care in Texas youth with depression or suicidality (i.e., suicidal ideation and/or suicidal behavior). The SRMP was developed for TX-YDSRN through a collaborative, iterative process, consistent with a Learning Healthcare System model. Results: The final SMRP included training, educational resources for research staff, educational resources for research participants, risk assessment and management strategies, and clinical and research oversight. Conclusion: The TX-YDSRN SRMP is one methodology for addressing youth participant suicide risk. The development and testing of standard methodologies with a focus on participant safety is an important next step to further the field of suicide prevention research.

Predicting Remission From Depression in Youth Receiving Outpatient Medication Management.

Objective: To examine 6-month remission rates of adolescents treated for depression in a university-based clinic and examine predictors of eventual remission.Methods: All patients aged 11-18 years treated in the clinic completed self-report measures assessing depression, suicidal ideation, anxiety, and associated symptoms. Remission was operationalized as a total score of ≤ 4 on the Patient Health Questionnaire-9 (PHQ-9) within 6 months of entering treatment.Results: Of the 430 patients, (76.74% female, 65.34% Caucasian, mean ± SD age 14.65 ± 1.69 years), 26.74% achieved remission within 6 months. Mean ± SD scores on the PHQ-9 at visit 1 (clinic entry) were 11.97 ± 4.76 for remitters (n = 115) and 15.03 ± 5.21 for non-remitters (n = 315). Predicted odds of remitting decreased as depressive symptom severity at visit 1 increased (OR = 0.941; 95% CI, 0.886 to 1.000; P = .051) and as scores on the Concise Associated Symptoms Tracking scale at treatment entry increased (OR = 0.971; 95% CI, 0.948 to 0.995; P = .017). As depression severity increased between visits, odds of remitting decreased (OR = 0.873; 95% CI, 0.827 to 0.921; P < .0001). Finally, adolescent males were more likely to achieve remission than females within 6 months (OR = 2.257; 95% CI, 1.351 to 3.771; P = .002).Conclusions: This study reports remission rates for depressed youth receiving medication management in a naturalistic outpatient setting. Results confirm that depression severity at treatment initiation and over time is a strong predictor of remission status. Additionally, monitoring associated symptoms via measurement-based care can provide important clinical information to inform treatment decisions.

Forty-Eight Week Outcomes of a Site-Randomized Trial of Combined Cognitive Behavioral Therapy and Medication Management Algorithm for Treatment of Depression Among Youth With HIV in the United States.

BACKGROUND: Studies suggest that manualized, measurement-guided, depression treatment is more efficacious than usual care but impact can wane. Our study among youth with HIV (YWH), aged 12-24 years at US clinical research sites in the International Maternal Pediatric Adolescent AIDS Clinical Trials Network, found a significant reduction in depressive symptoms among YWH who received a manualized, measurement-guided treatment. This paper reports outcomes up to 24 weeks after the intervention. METHODS: Eligibility included diagnosis of ongoing nonpsychotic depression. Using restricted randomization, sites were assigned to either combination cognitive behavioral therapy and medication management algorithm tailored for YWH or to enhanced standard of care, which provided psychotherapy and medication management. Site-level mean Quick Inventory for Depression Symptomatology Self-Report (QIDS-SR) scores and proportion of youth with treatment response (>50% decrease from baseline) and remission (QIDS-SR ≤ 5) were compared across arms using t tests. RESULTS: Thirteen sites enrolled 156 YWH, with baseline demographic factors, depression severity, and HIV disease status comparable across arms. At week 36, the site-level mean proportions of youth with a treatment response and remission were greater at combination cognitive behavioral therapy and medication management algorithm sites (52.0% vs. 18.8%, P = 0.02; 37.9% vs. 19.4%, P = 0.05), and the mean QIDS-SR was lower (7.45 vs. 9.75, P = 0.05). At week 48, the site-level mean proportion with a treatment response remained significantly greater (58.7% vs. 33.4%, P = 0.047). CONCLUSIONS: The impact of manualized, measurement-guided cognitive behavioral therapy and medication management algorithm tailored for YWH that was efficacious at week 24 continued to be evident at weeks 36 and 48.

Site-Randomized Controlled Trial of a Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression Among Youth Living With HIV in the United States.

BACKGROUND: Depression is frequent among youth living with HIV (YLWH). Studies suggest that manualized treatment guided by symptom measurement is more efficacious than usual care. SETTING: This study evaluated manualized, measurement-guided depression treatment among YLWH, aged 12-24 years at 13 US sites of the International Maternal Pediatric Adolescent AIDS Clinical Trials Network. METHODS: Using restricted randomization, sites were assigned to either a 24-week, combination cognitive behavioral therapy and medication management algorithm (COMB-R) tailored for YLWH or to enhanced standard of care, which provided standard psychotherapy and medication management. Eligibility included diagnosis of nonpsychotic depression and current depressive symptoms. Arm comparisons used t tests on site-level means. RESULTS: Thirteen sites enrolled 156 YLWH, with a median of 13 participants per site (range 2-16). At baseline, there were no significant differences between arms on demographic factors, severity of depression, or HIV status. The average site-level participant characteristics were as follows: mean age of 21 years, 45% male, 61% Black, and 53% acquired HIV through perinatal transmission. At week 24, youth at COMB-R sites, compared with enhanced standard of care sites, reported significantly fewer depressive symptoms on the Quick Inventory for Depression Symptomatology Self-Report (QIDS-SR score 6.7 vs. 10.6, P = 0.01) and a greater proportion in remission (QIDS-SR score ≤ 5; 47.9% vs. 17.0%, P = 0.01). The site mean HIV viral load and CD4 T-cell level were not significantly different between arms at week 24. CONCLUSIONS: A manualized, measurement-guided psychotherapy and medication management algorithm tailored for YLWH significantly reduced depressive symptoms compared with standard care at HIV clinics.

Assessment of safety and long-term outcomes of initial treatment with placebo in TADS.

OBJECTIVE: The authors examined whether initial assignment to receive placebo for 12 weeks followed by open active treatment as clinically indicated was associated with different levels of benefit and risk of harm across 36 weeks as compared with initial assignment to receive active treatments. METHOD: Adolescents with major depressive disorder (N=439) were randomly assigned to receive an initial 12 weeks of treatment with fluoxetine, cognitive-behavioral therapy (CBT), combination treatment with fluoxetine and CBT, or clinical management with placebo; those assigned to placebo received open active treatment as clinically indicated after 12 weeks of placebo. Assessments were conducted every 6 weeks for 36 weeks. The primary outcome measures were response and remission based on scores on the Children's Depression Rating Scale-Revised and the Clinical Global Impression improvement subscale. RESULTS: At week 36, the response rate was 82% in the placebo/open group and 83% in the active treatment groups. The remission rate was 48% in the placebo/open group and 59% in the active treatment groups, a difference that approached statistical significance. Patients who responded to placebo generally retained their response. Those who did not respond to placebo subsequently responded to active treatment at the same rate as those initially assigned to active treatments. There were no differences between groups in rates of suicidal events, study retention, or symptom worsening. CONCLUSIONS: Remission rates at 9 months were lower in patients treated initially with placebo, but 3 months of placebo treatment was not associated with any harm or diminished response to subsequent treatment.

Cognitions and depressive symptoms among ethnic minority adolescents.

Cognitive models have guided effective intervention strategies in the treatment of depression. However, little is known about the cognitive model's relevance in different cultural ethnic groups in the United States. This study examines the cross-sectional and longitudinal associations among cognitive variables and depressive symptoms among African American, Caucasian, and Hispanic adolescents in the United States. Community adolescents (N = 450) ages 14-18 years (African American n = 79; Caucasian n = 273; Hispanic n = 98) provided information regarding their depressive symptoms and cognitions at two surveys, 6 months apart. Self-efficacy, cognitive errors, and hopelessness were associated with concurrent depressive symptoms at baseline. In addition, cognitive errors at baseline, controlling for baseline depressive symptoms and the occurrence of stressful events, predicted depressive symptoms at follow-up. Ethnic differences disappeared when parent education level was controlled. Our findings demonstrate support for the cognitive model of depression across ethnic groups. The importance of controlling for social class when examining ethnic differences in psychological variables is highlighted by our findings.