[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06540547":3,"trial-entities:NCT06540547":96,"trial-summary:NCT06540547":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":62,"locations":64,"central_contacts":74,"overall_officials":84,"references":87,"see_also_links":95},"NCT06540547","STUDY23100082","Moms Managing Attention-Deficit\u002FHyperactivity Disorder (ADHD) Study","Supporting Expectant Mothers With ADHD Through the Transition to Parenthood","RECRUITING","2026-07-31","2026-01","2026-01-08","2025-01-19","University of Pittsburgh","OTHER",false,"The study will develop and test a behavioral program for pregnant individuals with Attention-Deficit\u002FHyperactivity Disorder (ADHD). This behavioral program will include skills for managing ADHD and related symptoms during pregnancy and after delivery and will be taught by a behavioral therapist in OB care settings.","Treating pregnant individuals with ADHD may improve parent and child wellbeing, parent-child interactions, and psychosocial familial factors to enhance family resilience and reduce prevalence\u002Fseverity of child mental health disorders. Using the information provided from stakeholder interviews and adaptations of an existing CBT intervention for parents of children with ADHD, the current study will develop the MomMA (Moms Managing ADHD) intervention and implement it via an open clinical trial (n=10 pregnant individuals), delivered by masters-level women's health behavioral therapists. Investigators will examine treatment acceptability, feasibility, and appropriateness, as well as implementation factors (fidelity, adherence, facilitators\u002Fbarriers) and qualitative data (e.g., feedback interviews). In addition, quantitative data (self-reported symptoms, parenting, and home environment measures; observed parent and child behavior; parent reported child temperament\u002Fbehavior) will be used to assess parent and child outcomes following the intervention. This mixed-methods model will offer a comprehensive examination of the MomMA intervention and inform a refined intervention model.",[19,20],"ADHD","Parenting",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},10,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","MomMA Intervention","Parents will receive sessions of CBT-based behavioral intervention with components targeted specifically towards expectant parents with ADHD. Treatment will be delivered by therapists embedded in OB care settings. The number and specific content of sessions will be determined based on community partner feedback.",[32],[36,40,43],{"measure":37,"description":38,"timeFrame":39},"Intervention Acceptability","Therapist and participant report of intervention acceptability will be assessed using the 4-item Acceptability of Intervention Measure (AIM), rated from rated from 1 (completely disagree) to 5 (completely agree), with scores greater than or equal to 16 indicating good acceptability.","Post Intervention at 4-month postpartum",{"measure":41,"description":42,"timeFrame":39},"Intervention Appropriateness","Therapist and participant report of intervention appropriateness will be assessed using the 4-item Intervention Appropriateness Measure (IAM), rated from 1 (completely disagree) to 5 (completely agree), with scores greater than or equal to 16 indicating good appropriateness.",{"measure":44,"description":45,"timeFrame":39},"Intervention Feasibility","Therapist and participant report of intervention feasibility will be assessed using the 4-item Feasibility of Intervention Measure (FIM), rated from 1 (completely disagree) to 5 (completely agree), with scores greater than or equal to 16 indicating good feasibility.",[],"FEMALE","18 Years","55 Years",{"inclusion":51,"exclusion":56,"raw_text":61},[52,53,54,55],"(1) meet full DSM-5 criteria for ADHD","(2) are between 20- and 32-weeks of gestation","(3) speak English","(4) will deliver at the University of Pittsburgh Medical Center (UPMC) Magee Women's Hospital (MWH)",[57,58,59,60],"(1) active substance use disorder","(2) intellectual disability","(3) other severe mental illness, including bipolar disorder, psychosis, and major depressive disorder with suicidal ideation or requiring higher level of care (inpatient or partial\u002Fintensive outpatient)","(4) high risk pregnancies requiring transfer of care to Maternal-Fetal Medicine (e.g., maternal cancer, multiples, placenta accreta) and\u002For fetus known to have a severe congenital condition.","Inclusion Criteria:\n\n* (1) meet full DSM-5 criteria for ADHD\n* (2) are between 20- and 32-weeks of gestation\n* (3) speak English\n* (4) will deliver at the University of Pittsburgh Medical Center (UPMC) Magee Women's Hospital (MWH)\n\nExclusion Criteria:\n\n* (1) active substance use disorder\n* (2) intellectual disability\n* (3) other severe mental illness, including bipolar disorder, psychosis, and major depressive disorder with suicidal ideation or requiring higher level of care (inpatient or partial\u002Fintensive outpatient)\n* (4) high risk pregnancies requiring transfer of care to Maternal-Fetal Medicine (e.g., maternal cancer, multiples, placenta accreta) and\u002For fetus known to have a severe congenital condition.",[63],"ADULT",[65],{"facility":66,"status":8,"city":67,"state":68,"zip":69,"country":70,"geoPoint":71},"UPMC Magee Women's Hospital","Pittsburgh","Pennsylvania","15213","United States",{"lat":72,"lon":73},40.44062,-79.99589,[75,80],{"name":76,"role":77,"phone":78,"email":79},"Heather M Joseph, DO","CONTACT","4122465339","liebherrh@upmc.edu",{"name":81,"role":77,"phone":82,"email":83},"Michelle Wilson","412-420-8309","wilsonm13@upmc.edu",[85],{"name":76,"affiliation":13,"role":86},"PRINCIPAL_INVESTIGATOR",[88,92],{"pmid":89,"type":90,"citation":91},"34937412","BACKGROUND","Joseph HM, Khetarpal SK, Wilson MA, Molina BSG. Parent ADHD Is Associated With Greater Parenting Distress in the First Year Postpartum. J Atten Disord. 2022 Jul;26(9):1257-1268. doi: 10.1177\u002F10870547211066488. Epub 2021 Dec 23.",{"pmid":93,"type":90,"citation":94},"23477479","Chronis-Tuscano A, Clarke TL, O'Brien KA, Raggi VL, Diaz Y, Mintz AD, Rooney ME, Knight LA, Seymour KE, Thomas SR, Seeley J, Kosty D, Lewinsohn P. Development and preliminary evaluation of an integrated treatment targeting parenting and depressive symptoms in mothers of children with attention-deficit\u002Fhyperactivity disorder. J Consult Clin Psychol. 2013 Oct;81(5):918-25. doi: 10.1037\u002Fa0032112. Epub 2013 Mar 11.",[],{"nct_id":4,"conditions":97,"biomarkers":99},[98],"Attention Deficit Hyperactivity Disorder",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study, meaning you will receive a specific treatment. It is an open clinical trial, planning to include 10 pregnant individuals.","completed","Moms Managing ADHD Study for Pregnant Individuals","This study is testing a new behavioral program called MomMA (Moms Managing ADHD) for pregnant individuals with Attention-Deficit\u002FHyperactivity Disorder (ADHD). The program uses a type of talk therapy (CBT-based behavioral intervention) to help you manage ADHD symptoms during and after pregnancy. Therapists will provide these sessions in your OB care setting. To join, you must be a woman between 18 and 55 years old, 20-32 weeks pregnant, speak English, and plan to deliver at UPMC Magee Women's Hospital. The study aims to see if the MomMA program is acceptable, appropriate, and practical for participants. The current recruitment status is unclear, and the study plans to enroll 10 participants.","Your progress will be measured after the intervention at 4-month postpartum.",108,"You will receive sessions of the MomMA Intervention from therapists embedded in OB care settings. The study will measure how acceptable, appropriate, and feasible the intervention is after delivery at 4-month postpartum.","Not stated in the trial record.",[],"v2"]