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临床试验/NCT06679010
NCT06679010已完成不适用

A Therapist-guided Online-delivered Group Counseling Program for Pregnant Women and New Mothers With ADHD: A Feasibility Study of AMOR; ADHD, Mothers Online Resources

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2025年1月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
The Negative Effects Questionnaire (NEQ)

研究概览

简要总结

The primary aim of this study is to investigate the feasibility of the program AMOR for pregnant women and new mothers with Attention Deficit Hyperactivity Disorder (ADHD), by examining adherence, credibility, treatment satisfaction, and negative effects. The secondary objective is to obtain preliminary information about the short-term clinical outcomes of the program on self-report scales assessing symptoms of ADHD, stress, anxiety, depression, difficulties in emotion regulation, and quality of life.

The main questions this study aims to answer:

  1. To what extent will pregnant women and new mothers with ADHD adhere to, find useful, be satisfied with, and experience negative effects of the program AMOR?
  2. To what extent will pregnant women and new mothers with ADHD experience improvements in ADHD symptoms, stress, anxiety, depression, difficulties in emotion regulation, and quality of life?

Participants will:

  • listen to the 10 podcasts in the program
  • attend the 10 online guided sessions in the program
  • fill in questionnaires related to the primary and secondary objectives
  • some will be invited to participate in an online semi-structured interview

详细描述

Methods The content of the program has been developed by the Danish ADHD Association (ADHD-foreningen) in collaboration with researchers from Aarhus University and the University of Southern Denmark. This program is specifically designed for pregnant women and new mothers with ADHD as an online group intervention. The online format ensures that transportation time is not a barrier to participation, allowing women from across the country to take part. This is particularly important for inclusion, as the program must be accessible during pregnancy. The program is developed based on the extensive knowledge that the ADHD Association has gained from over 40 years of working with people with ADHD. The content is tailored to the key concerns and challenges related to ADHD in the perinatal period, the period related to pregnancy and the first year postpartum and is based on the general principles of cognitive behavioral therapy. It is also inspired by existing literature, a survey among the female members of the ADHD Association, and interviews with women with ADHD about their experiences with pregnancy and postpartum.

Procedure The feasibility trial will be carried out as a mixed-method process evaluation, including both interviews and questionnaire data. The program will proceed over 10 weeks. Questionnaires will be distributed from Research Electronic Data Capture (REDCap) via e-boks at baseline and at 1 week post-program. Interviews will be carried out as focus groups with three participants from each of the three counselling groups and a member of the research team.

Eligible participants will be assigned a group, with the first group starting in early 2025.

Measurements At baseline, before starting the first session of the program, the women will be asked to fill in questionnaires about their sociodemographic and background information and the following validated and standardized questionnaires; the Adult ADHD Self-Rating Scale (ASRS), the Generalized Anxiety Disorder assessment (GAD7), the Edinburg Postnatal Depression scale (EPDS), the Difficulties in Emotion Regulation Scale (DERS), and the Adult ADHD Quality of Life Measure (AAQoL). One week after the final 10-week program period, the women will be asked to fill in the following questionnaires: The Client Satisfaction Questionnaire (CSQ-8), the Credibility and Expectancy Scale (CEQ), the Negative Effects Questionnaire (NEQ) and again the six questionnaires that were also filled in at baseline. In addition to the quantitative measurements, we will conduct semi-structured interviews with three women from each group one week after the end of the program to assess their subjective perspectives on barriers and facilitators to participate in the program. We will use Clarke and Braun thematic analysis on the interview.

Statistical analysis plan Descriptive statistics For participant characteristics, we will summarize baseline sociodemographic and clinical characteristics using means and standard deviations for continuous variables, and frequencies and percentages for categorical variables. For program adherence, we will calculate adherence rates by assessing attendance records for each session.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women or new mothers with an ADHD diagnosis (WHO ICD-10; F90 or F98.8)
  • above 18 years
  • access to a computer and the internet
  • speaks and reads Danish

排除标准

  • severe mental disorders, such as mental retardation, schizophrenia, psychosis or bipolar disorder
  • a score above 15 on the Generalized Anxiety Disorder assessment or a score above 18 on the Edinburg Postnatal Depression scale administered
  • current alcohol or substance abuse

研究组 & 干预措施

Intervention group

Experimental

干预措施: Online group counseling (Other)

结局指标

主要结局

The Negative Effects Questionnaire (NEQ)

时间窗: From enrollment to the end of the program 11 weeks

Measure of experienced negative effects during treatment. It contains 20 items that are scored on a five-point Likert-scale (0-4) and differentiates between negative effects that are attributed to treatment and those possibly caused by other circumstances, as well as one open-ended questions.

The Credibility and Expectancy Scale (CEQ)

时间窗: From enrollment to the end of the program 11 weeks

Credibility of the intervention is measured by the third item from the Credibility and Expectancy Scale (CEQ): "How confident would you be in recommending this treatment to a friend who experiences similar problems?". Moreover, participants will be asked how likely they will be to continue to use the techniques from the program, with response options ranging from: "Very unlikely" to "Very likely".

Adherence

时间窗: From enrollment to the end of the program

Adherence is assessed by drop-out rates and participation in the sessions

The Client Satisfaction Questionare (CSQ-8)

时间窗: From enrollment to the end of the program 11 weeks

A measure of the participants\' satisfaction with the intervention. The questionnaire consist of eight items measured on a four-point scale with total scores ranging from 8-32.

次要结局

  • The Adult ADHD Self-Rating Scale (ASRS)(From enrollment to the end of the program 11 weeks)
  • The Perceived Stress Scale (PSS)(From enrollment to the end of the program 11 weeks)
  • The Generalized Anxiety Disorder assessment (GAD7)(From enrollment to the end of the program 11 weeks)
  • The Edinburg Postnatal Depression scale (EPDS)(From enrollment to the end of the program 11 weeks)
  • The Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)(From enrollment to the end of the program 11 weeks)
  • The Adult ADHD Quality of Life Measure (AAQoL)(From enrollment to the end of the program 11 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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