A Feasibility Study of AMOR; ADHD, Mothers Online Resources

NCT06679010 | Completed DMC

• 2 other identifiers: S-202400742021-0139
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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:

• 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

Conditions

Postpartum Depression (PPD); Anxiety; Stress; Emotional Dysregulation; Quality of Life; Attention Deficit Disorder With Hyperactivity; Pregnancy; Mother; Women

Keywords

AMOR; feasibility; online counselling of pregnant women with ADHD; mixed methods evaluation

Outcome Measures

Primary Outcomes (4)

• The Negative Effects Questionnaire (NEQ)

  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.

  From enrollment to the end of the program 11 weeks

• The Credibility and Expectancy Scale (CEQ)

  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".

  From enrollment to the end of the program 11 weeks

• Adherence

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

  From enrollment to the end of the program

• The Client Satisfaction Questionare (CSQ-8)

  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.

  From enrollment to the end of the program 11 weeks

Secondary Outcomes (6)

• 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

Study Arms (1)

Intervention group

EXPERIMENTAL

Other: Online group counseling

Interventions

Online group counseling OTHER

The program progresses as one weekly group session over 10 weeks, each with its own topic. The core components of the program include psychoeducation, training self-compassion and acceptance, cognitive restructuring, interpersonal skills training, systems and management of daily life activities, prevention of conflicts, and the mother-baby relation. Participants will meet online as a group together with the instructor, a consultant from the ADHD Association, who will lead and facilitate the sessions. Before each session, there is a podcast episode that covers the topic of each session. The 10 podcasts feature interviews with clinicians, researchers, and women with ADHD, focusing on the themes from the program's sessions.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Sygeforsikringen danmark: collaborator

Study Sites (1)

The Danish ADHD Association

Odense, 5000, Denmark

Location

Related Publications (20)

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Related Links

• Related Info

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Depression, Postpartum; Anxiety Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a feasibility trial with an uncontrolled, within-group, pre-post design

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: January 22, 2025
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)