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Идёт набор NCT07001293

Expectant Moms Managing Attention-Deficit/ Hyperactivity Disorder

Без фазы С лечением ADHD Perinatal Behavioral Intervention

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: MomMA Intervention, Treatment as Usual (TAU).
Кому может быть актуально
Состояния в реестре: ADHD, Perinatal, Behavioral Intervention. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Supporting Expectant Mothers With ADHD Through the Transition to Parenthood: A Pilot RCT

Обзор

The goal of this study is to test a behavioral program for pregnant individuals with ADHD. This behavioral program focuses on skills for managing ADHD and related symptoms in pregnancy and postpartum. This pilot effectiveness-implementation trial aims to (1) preliminarily evaluate the MomMA behavioral intervention compared to treatment as usual (TAU) on clinical outcomes and (2) evaluate implementation outcomes, including feasibility and acceptability of clinic screening within existing OB workflows; assessment and intervention protocols; provider training/fidelity to manual; and all other study protocols from the perspective of real-world providers and participants.

Подробное описание

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/severity of child mental health disorders. The current study will test the MomMA (Moms Managing ADHD) intervention and implement it via a randomized controlled trial (N= 40 pregnant women with ADHD; 20 receiving the behavioral intervention and 20 receiving TAU), delivered by women's health behavioral therapists. Investigators will examine treatment acceptability, feasibility, and appropriateness, as well as implementation factors (fidelity, adherence, facilitators/barriers). In addition, quantitative data will be used to assess parent and child clinical outcomes, including maternal ADHD symptom severity and impairment (primary), parent-child attachment, and infant temperament/behavior. Finally, changes in target mechanisms (executive function and emotion regulation) and whether changes in the target are associated with change in clinical outcomes will be explored.

Вмешательства

  • Поведенческое MomMA Intervention
    The MomMA program is a CBT-based behavioral intervention with components targeted specifically towards expectant parents with ADHD. Treatment will be delivered by therapists embedded in OB care settings.
  • Другое Treatment as Usual (TAU)
    Participants will receive treatment as usual, including but not limited to medication and behavioral therapy. No participation in treatment is required.

Первичные конечные точки

  • Intervention Acceptability [Срок оценки: Post Intervention (36 weeks gestational age)]
  • Intervention Feasibility [Срок оценки: Post Intervention (36 weeks gestational age)]
  • Intervention Appropriateness [Срок оценки: Post Intervention (36 weeks gestational age)]
  • ADHD Symptom Severity [Срок оценки: Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum)]
  • ADHD Functional Impairment [Срок оценки: Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum)]
  • Perinatal Mood/Distress [Срок оценки: Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum)]
Вторичные конечные точки (4)
  • Attachment [Срок оценки: Postpartum follow-up (4-5 months postpartum)]
  • Home Environment [Срок оценки: Postpartum follow-up (4-5 months postpartum)]
  • Infant Behavior [Срок оценки: Postpartum follow-up (4-5 months postpartum)]
  • Parent-Child Interaction [Срок оценки: Postpartum follow-up (4-5 months postpartum)]

Критерии участия

Критерии включения

  • meets full DSM-5 criteria for ADHD
  • is between 14- and 22-weeks of gestation
  • 18 years of age or older
  • English speaking
  • Lives in Pennsylvania

Критерии исключения

  • substance use disorders requiring dual diagnosis treatment
  • intellectual disability
  • bipolar disorder, psychosis, and major depressive disorder with suicidal ideation
  • the following high complexity medical conditions during pregnancy: maternal cancer, multiples, placenta accreta, and/or fetus known to have a severe congenital condition

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • UPMC Magee-Womens Hospital — Pittsburgh

Публикации

  • 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/hyperactivity disorder. J Consult Clin Psychol. 2013 Oct;81(5):918-25. doi: 10.1037/a0032112. Epu PMID 23477479
  • 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: 10.1177/10870547211066488. Epub 2021 Dec 23. PMID 34937412

Идентификаторы

NCT: NCT07001293 · STUDY25030051

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗