{"doi":"10.1111/bdi.13489","title":"A 6‐month, prospective, randomized controlled trial of customized adherence enhancement versus a bipolar‐specific educational control in poorly adherent adolescents and young adults living with bipolar disorder","abstract":"OBJECTIVE: Few studies have addressed medication adherence in adolescents and young adults (AYAs) with bipolar disorder (BD). This 6-month prospective randomized-controlled trial (RCT) tested customized adherence enhancement for adolescents and young adults (CAE-AYA), a behavioral intervention for AYAs versus enhanced treatment as usual (ETAU). METHODS: Inclusion criteria were AYAs age 13-21 with BD type I or II with suboptimal adherence defined as missing ≥20% of medications. Assessments were conducted at Screening, Baseline, and weeks 8, 12 and 24. Primary outcome was past 7 day self-reported Tablets Routine Questionnaire (TRQ) validated by electronic pillbox monitoring (SimpleMed). Symptom measures included the Hamilton Depression Rating Scale (HAM-D) and Young Mania Rating Scale (YMRS). RESULTS: The mean sample age (N = 36) was 19.1 years (SD = 2.0); 66.7% (N = 24) female, BD Type I (81%). The mean missed medication on TRQ for the total sample was 35.4% (SD = 28.8) at screening and 30.4% (SD = 30.5) at baseline. Both CAE-AYA and ETAU improved on TRQ from screening to baseline. Baseline mean missed medication using SimpleMed was 51.6% (SD = 38.5). Baseline HAM-D and YMRS means were 7.1 (SD = 4.7) and 6.0 (SD = 7.3), respectively. Attrition rate at week 24 was 36%. Baseline to 24-week change on TRQ, adjusting for age, gender, educational level, living situation, family history, race, and ethnicity, showed improvement favoring CAE-AYA versus ETAU of 15%. SimpleMed interpretation was limited due to substantial missing data. There was a significant reduction in depression favoring CAE-AYA. CONCLUSIONS: CAE-AYA may improve adherence in AYAs with BD, although conclusions need to be made cautiously given study limitations. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier: NCT04348604.","journal":"Bipolar Disorders","year":2024,"id":502920,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9499,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT04348604"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":300727,"name":"Melissa P. DelBello","orcid":"0000-0003-1837-4126","position":1,"is_corresponding":false},{"id":262424,"name":"Avani C. Modi","orcid":"0000-0002-7580-3751","position":2,"is_corresponding":false},{"id":340297,"name":"Farren Briggs","orcid":"0000-0003-0903-1359","position":3,"is_corresponding":false},{"id":944112,"name":"Larry F. Forthun","orcid":"0000-0003-1232-2413","position":4,"is_corresponding":false},{"id":944111,"name":"Molly McVoy","orcid":"0000-0003-4967-6055","position":5,"is_corresponding":false},{"id":890089,"name":"Joy Yala","orcid":null,"position":6,"is_corresponding":false},{"id":944617,"name":"Raechel Cooley","orcid":null,"position":7,"is_corresponding":false},{"id":1254211,"name":"Jessica Black","orcid":null,"position":8,"is_corresponding":false},{"id":944115,"name":"Carla Conroy","orcid":"0000-0002-7815-7353","position":9,"is_corresponding":false},{"id":315573,"name":"Martha Sajatovic","orcid":"0000-0002-3073-668X","position":10,"is_corresponding":false},{"id":436037,"name":"Jennifer B. Levin","orcid":"0000-0003-1214-0636","position":0,"is_corresponding":true}],"reference_count":47,"raw_metadata":null,"created_at":"2026-07-19T02:10:27.781502Z","pmid":"39231780","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}