PURPOSE: This study aimed to determine whether a blended Infant MassageeParenting Enhancement Program (IMPEP) improved maternal psychosocial health outcomes (parenting stress, depressive symptoms, self-esteem, maternal attachment) and maternal-infant interaction among substanceaddicted mothers (SAMs) actively engaged in outpatient rehabilitation. METHODS: Designed as a randomized, three-group controlled trial testing two levels of psychoeducational intervention (IMPEP vs. PEP) and a control group (standard care parenting resources), the studywas conducted in two substance abuse centers in southeast Florida on a convenience sample of 138 recovering SAM-infant pairs. IMPEP or PEP classes were held weekly onWeeks 2e5, with data collected at baseline (Week 1),Week 6, andWeek 12 via structured interviews, observation (Observation Checklist onMaternal-Infant Interaction), and self-administered questionnaires (Abidin Parenting Stress Index, Beck Depression Inventory, Rosenberg Self-Esteem Scale, Muller's Maternal Attachment Inventory), analyzed descriptively and inferentially using Kruskall-Wallis analysis of variance and post hoc Wilcoxon rank sum and Mann-Whitney U tests. RESULTS: Both IMPEP and PEP groups had significantly increased Parenting Stress Index scores (decreased parenting stress) and decreased Beck Depression Inventory scores (decreased depressive symptoms) compared to controls at Week 12, whereas there were no clinically meaningful differences among study groups in Rosenberg Self-Esteem Scale, Muller's Maternal Attachment Inventory, or Observation Checklist on Maternal-Infant Interaction scores. Only the IMPEP group showed significant improvements in both psychological and physical (waist-hip ratio) measures of parenting stress over time. CONCLUSIONS: The findings suggest that infant massage blended into a structured parenting program has value-added effects in decreasing parenting stress and maternal depressive symptoms, but not on SAM's self-esteem, attachment, or maternal-infant interaction.
Adult ; Depressive Disorder/*prevention & control ; Female ; Florida ; Humans ; Infant ; Infant, Newborn ; Male ; Massage ; Maternal Behavior/*psychology ; Mother-Child Relations/*psychology ; Mothers/*education/*psychology ; Parenting/*psychology ; Program Evaluation ; Self Concept ; Stress, Psychological ; Substance-Related Disorders/*psychology/rehabilitation ; Young Adult

BACKGROUND: Secukinumab demonstrated sustained efficacy in patients with ankylosing spondylitis (AS) through 5 years in pivotal Phase III studies. Here, we present efficacy and safety results (52-week) of secukinumab in patients with AS from the MEASURE 5 study. METHODS: MEASURE 5 was a 52-week, Phase III, China-centric study. Eligible patients were randomly assigned (2:1) to receive subcutaneous secukinumab 150 mg or placebo weekly for the first five doses and then once every 4 weeks (q4w). All placebo patients switched to secukinumab 150 mg q4w starting at Week 16. Primary endpoint was Assessments of SpondyloArthritis international Society (ASAS) 20 at Week 16. Randomization was stratified by region (China vs. non-China). RESULTS: Of 458 patients (secukinumab 150 mg, N = 305; placebo, N = 153) randomized, 327 (71.4%) were from China and 131 (28.6%) were not from China. Of these, 97.7% and 97.4% patients completed Week 16 and 91.1% and 95.3% (placebo-secukinumab) patients completed Week 52 of treatment. The primary endpoint was met; secukinumab significantly improved ASAS20 response at Week 16 vs. placebo (58.4% vs. 36.6%; P < 0.0001); corresponding rate in the Chinese population was 56.0% vs. 38.5% (P < 0.01). All secondary efficacy endpoints significantly improved with secukinumab 150 mg in the overall population at Week 16; responses were maintained with a trend toward increased efficacy from Week 16 to 52. No new or unexpected safety signals were reported up to Week 52. CONCLUSIONS: Secukinumab 150 mg demonstrated rapid and significant improvement in signs and symptoms of AS. Secukinumab was well tolerated and the safety profile was consistent with previous reports. Efficacy and safety results were comparable between the overall and Chinese populations. TRIAL REGISTRATION ClinicalTrials.gov, NCT02896127; https://clinicaltrials.gov/ct2/show/NCT02896127?term=NCT02896127&draw=2&rank=1.
Antibodies, Monoclonal/therapeutic use* ; Antibodies, Monoclonal, Humanized ; China ; Double-Blind Method ; Humans ; Spondylitis, Ankylosing/drug therapy* ; Treatment Outcome