Clinical trial NCT06679010: A Feasibility Study of AMOR; ADHD, Mothers Online Resources
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Mother
Women
Attention Deficit Disorder With Hyperactivity
Postpartum Depression (PPD)
Anxiety
Stress
Emotional Dysregulation
Quality of Life
Keywords: AMOR
feasibility
online counselling of pregnant women with ADHD
mixed methods evaluation
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Sygeforsikringen danmark
First posted: 2024-11-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a feasibility trial with an uncontrolled, within-group, pre-post design
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Analyses For the primary outcomes, program satisfaction (CSQ-8), credibility and expectancy (CEQ), and negative effects (NEQ), we will summarize scores using means and standard deviations.

For the secondary outcomes, ADHD symptoms (ASRS), perceived stress (PSS), anxiety (GAD-7), depression (EPDS), emotion regulation (DERS-16), and quality of life (AAQoL), we will use paired t-test to compare pre- and post-intervention scores.

Power calculation Given the feasibility nature of this study, a formal power calculation is not conducted. However, the sample size of 30 participants, divided into three groups, is deemed sufficient to provide preliminary insights into program feasibility, adherence, and potential impacts on clinical outcomes.

Processing of personal data in the project All personal data will be processed in compliance with the General Data Protection Regulation (GDPR) and the Danish Data Protection Act. Any personally sensitive information is processed by OPEN (Open, Patient data Explorative Network) in personally identifiable form for as long as it is necessary for the research purpose. The storages of information are in accordance with responsible research practice and in relation to general data protection regulation. Individual participants will not be identifiable in published data, as the information of trial participants is anonymized, and individuals cannot be recognized. We will prioritize the protection of participants privacy and adhere to ethical guidelines. Anonymization involves removing personal identification details to prevent the disclosure of individual participants identities in published results and by reporting results that are based on at least 5 individuals. When the data is no longer necessary for the research project, it will be sent to the national archive and stored for five years. The project is registered at the University of Southern Denmark (journal nr: 12.303 - HELP - Mental health in pregnant women and new mothers with ADHD).

Economy The initiative for this trial was taken by associate professor Kathrine Bang Madsen. Funding is provided by Sygeforsikring "danmark" (Journalnr. 2021-0139 HELP - Mental health in pregnant women and new mothers with ADHD) as part of a larger project called HELP with an amount of DKK 5 mio, of which DKK 1.5 mio covers the development and evaluation of the counselling program. The financial support cover costs related to program development (to ADHD-foreningen), participant recruitment, and data analysis, and is administered by the University of Southern Denmark (SDU). The funding body has had no role in the study design, data collection, data analysis, data interpretation, or manuscript writing.

Recruitment and informed consent The Danish ADHD Association will advertise for the counselling program and the research project on their homepage and social media platforms. Those interested in participating can sign up by providing their email address via the homepage. They will then receive an email with details about the research project and are encouraged to reply with their phone number. The instructor of the program from the Danish ADHD Association will contact the participant by phone and screen the participant based on the eligibility criteria and provide the participant with information about the study. The verbal information given by phone includes the purpose and method of the program and the feasibility study, the voluntary nature of participation, that neither participation or non-participation will have an influence on other treatment options available to the individual, and the right to a consideration period (one week). The consent process is a dialogue, and the individual participant can ask questions about the program and study.

During the phone conversation, participants will be asked about their pregnancy status, since they will need to be pregnant. They are asked to share information about their ADHD diagnosis, including when they were diagnosed. Additionally, we will collect information about their living situation, such as whether they live with the child's father, their employment status, and similar details. If the participant meets the inclusion and exclusion criteria and decides to participate in the study, she will receive written information about the study and a consent form through e-mail via REDCap (Research Electronic Data Capture), which can be signed electronically. From the day of receiving the written information, the participant will have one week to consider participating. After signing, the participant will receive a copy of the consent form. The consent form will be stored in REDCap.

Ethics The trial poses minimal risks and offers potential therapeutic benefits that justify its conduct. The intervention is expected to significantly improve participants well-being and quality of life, benefiting both mother and baby. The counselling program AMOR is the first program to address the needs of pregnant women and new mothers. However, based on experiences with similar online programs for adults with ADHD (outside the perinatal period), the program is expected to enhance understanding of ADHD during pregnancy and childbirth, providing practical strategies for managing daily life during pregnancy and as a new parent. Other studies have not reported on negative effects, however, during each session, participants will be informed by the instructor to contact their general practitioner, midwife, or health nurse if they need more assistance than the program can provide. In addition, we will assess any potential negative effects after the end of the program. Participants will be informed of their rights and the compensation scheme for any injury related to the intervention.

Should participants exhibit scores exceeding 15 on the Generalized Anxiety Disorder-7 (GAD-7) scale and 18 on the Edinburgh Postnatal Depression Scale (EPDS) at baseline, they will be contacted by phone by one of the responsible investigators and encouraged to consult with their healthcare provider, such as their doctor or midwife and they will be informed that they are not eligible to participate in this study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Negative Effects Questionnaire (NEQ)
timeFrame: From enrollment to the end of the program 11 weeks
measure: The Credibility and Expectancy Scale (CEQ)
timeFrame: From enrollment to the end of the program 11 weeks
measure: Adherence
timeFrame: From enrollment to the end of the program
measure: The Client Satisfaction Questionare (CSQ-8)
timeFrame: From enrollment to the end of the program 11 weeks
Secondary outcomes:
measure: The Adult ADHD Self-Rating Scale (ASRS)
timeFrame: From enrollment to the end of the program 11 weeks
measure: The Perceived Stress Scale (PSS)
timeFrame: From enrollment to the end of the program 11 weeks
measure: The Generalized Anxiety Disorder assessment (GAD7)
timeFrame: From enrollment to the end of the program 11 weeks
measure: The Edinburg Postnatal Depression scale (EPDS)
timeFrame: From enrollment to the end of the program 11 weeks
measure: The Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
timeFrame: From enrollment to the end of the program 11 weeks
measure: The Adult ADHD Quality of Life Measure (AAQoL)
timeFrame: From enrollment to the end of the program 11 weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: The Danish ADHD Association
Study officials:
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