跳至主要内容
临床试验/NCT06540547
NCT06540547
招募中
不适用

Supporting Expectant Mothers With ADHD Through the Transition to Parenthood

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 10 人2025年1月19日
适应症ADHDParenting
干预措施MomMA Intervention

概览

阶段
不适用
干预措施
MomMA Intervention
疾病 / 适应症
ADHD
发起方
University of Pittsburgh
入组人数
10
试验地点
1
主要终点
Intervention Appropriateness
状态
招募中
最后更新
3个月前

概览

简要总结

The study will develop and test a behavioral program for pregnant individuals with Attention-Deficit/Hyperactivity 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.

详细描述

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. 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/barriers) 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/behavior) 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.

注册库
clinicaltrials.gov
开始日期
2025年1月19日
结束日期
2026年7月31日
最后更新
3个月前
研究类型
Interventional
研究设计
Single Group
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Heather Joseph

Assistant Professor

University of Pittsburgh

入排标准

入选标准

  • (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)

排除标准

  • (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/intensive outpatient)
  • (4) high risk pregnancies requiring transfer of care to Maternal-Fetal Medicine (e.g., maternal cancer, multiples, placenta accreta) and/or fetus known to have a severe congenital condition.

研究组 & 干预措施

MomMA Intervention

干预措施: MomMA Intervention

结局指标

主要结局

Intervention Appropriateness

时间窗: Post Intervention at 4-month postpartum

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.

Intervention Acceptability

时间窗: Post Intervention at 4-month postpartum

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.

Intervention Feasibility

时间窗: Post Intervention at 4-month postpartum

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.

研究点 (1)

Loading locations...

相似试验