AzTrials
AzTrials

Mental Health DisordersNCT07098260

DECIDE to Improve Maternal Mental Health Care Delivery

A study testing MOMs DECIDE Provider Training in people with Mental Health Disorders, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Appropriate training for perinatal mental health care is an important public health concern as mental health disorders are common pregnancy complications. Perinatal and mental health care providers report the difficulty of treating perinatal individuals due to insufficient information available regarding mental health… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Mental Health Disorders
What is being tested?
MOMs DECIDE Provider Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
14 Feb 2025to 15 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Perinatal or mental health care providers who currently provide perinatal mental health care within health systems
  • Ages between 18 and 64
  • Must be able to understand the training content in English and comfortably complete the assessments and share feedback in English

Who cannot join

  • Healthcare providers who do not practice as part of a healthcare system
  • Healthcare providers who do not practice in the U.S.
  • Healthcare providers who do not currently provide perinatal mental health care

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rutgers, the State University of New Jersey

    Piscataway, New Jersey, 08854

Other trials in United States

About this study

Appropriate training for perinatal mental health care is an important public health concern as mental health disorders are common pregnancy complications. Perinatal and mental health care providers report the difficulty of treating perinatal individuals due to insufficient information available regarding mental health treatment decisions, differences in beliefs and attitudes, and concerns about adverse effects on patients, such as self-harm and suicide. Effective shared decision-making skills can improve perinatal and mental health care providers' competencies to meet the unique decision needs of perinatal individuals, particularly those with mental health disorders. The proposed project titled "DECIDE to Improve Maternal Mental Health Care Delivery" aims to adapt the DECIDE Provider Training developed by Dr. Alegria and her team,1 to improve the rapid and wide dissemination and implementation of DECIDE in meeting the mental health needs of perinatal individuals. DECIDE stands for Decide the problem; Explore the questions; Closed or open-ended questions; Identify the who, why, or how of the problem; Direct questions to your health care professional; Enjoy a shared solution. The DECIDE provider training was developed based on theories of intergroup contact in social psychology and a patient-centered framework.28-30 DECIDE teaches mental health providers how to improve perspective-taking, reduce attributional errors, and increase receptivity to the client population.1,15-17 The proposed project will (1) make content adaptation (i.e., adding topical training content to fit perinatal mental health care) and process adaption (i.e., creating asynchronous training modules to reduce the burden for care providers) to the DECIDE Provider Training and (2) assess the acceptability, appropriateness, and usability of adapted DECIDE provider training for rapid and wide dissemination and implementation of DECIDE in maternal mental health care delivery.

Read the detailed description

The project involves two phases. Phase 1: Adapt DECIDE to translate the knowledge of the DECIDE Provider Training into maternal mental health care. The investigators will use Iterative Decision-Making for the Evaluation of Adaptations (IDEA)20 and the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME)21 as guiding frameworks for the adaptation. AHRQ's synthesis of research evidence for pharmacologic and nonpharmacologic treatments for maternal mental health care27 will be used as the guiding tool for selecting the key questions for shared decision making (SDM). The example questions include: whether to offer nonpharmacologic interventions alone or in combination with pharmacologic intervention for specific perinatal mental health conditions and which nonpharmacologic interventions for perinatal mental health lead to optimal patient outcomes. The core content of the DECIDE Provider Training will be retained in a 3-hour asynchronous training with 5 modules: shared decision-making, perspective-taking (understanding perinatal individuals' circumstances and perceptions), patient activation, attributional errors, and being a responsive provider to perinatal individuals. Vignettes will be created to address patient and provider concerns for perinatal mental health, such as pharmacological mental health treatment in relation to breastfeeding, pregnancy complications, maternal harms and child outcomes, patient sociodemographic factors, mental illness and prior pregnancy history, and patient preferences.

Stakeholder engagement to adapt DECIDE Provider Training: The investigators will establish a provider advisory board composed of perinatal and mental health care providers, and recruit 3 subject matter experts with expertise in perinatal mental health care, SDM, and health systems.

Recruitment of Provider Advisory Board: The investigators will recruit 5 provider advisory board members to guide adaptations to the DECIDE Provider Training. The members will include those who provide perinatal mental health care such as nurses, psychologists, social workers, midwives, counselors, peer specialists, and other providers. The advisory board will help identify content adaptations to be made to fit mental health treatment for perinatal individuals, review asynchronous training modules and vignettes, provide feedback on the provider training materials for revisions to be made, and advise how to best implement the adapted DECIDE provider training in health systems.

Recruitment of Subject Matter Experts: The investigators will recruit 3 subject matter experts with expertise in perinatal mental health, behavioral health, physical and emotional well-being, symptom management, and SDM. The experts will guide key content adaptations to be made to the provider training modules, provide relevant resources to create the content adaptation, co-develop scripts for the training vignettes with PI and Dr. Nakash (Consultant), and review provider training materials and make recommendations.

The investigators will conduct focus groups with the advisory board and subject matter experts to develop content adaptation and strategies for rapid and wide implementation of the DECIDE provider training in health systems. The focus groups will be held on the secure HIPPA-compliant Rutgers Zoom. Focus groups through Zoom have been reported to be an excellent method for programming and managing focus groups.39,40 A semi-structured topic guide consisting of broad, open-ended questions41 will include questions for structured stakeholder consultation/discussion on: (1) What are the anticipated key facilitators and barriers to using DECIDE as an SDM tool in health systems? (2) What are the components that must be included or avoided in the adaptations to the DECIDE Provider Training to ensure that perinatal and mental health providers in health systems use DECIDE skills taught?, and (3) What are appropriate and acceptable strategies to integrate the adapted DECIDE provider training into routine perinatal care processes?

Create, record, edit, and upload the adapted DECIDE provider training in Canvas: Gathering stakeholders' input, the investigators will develop training modules and scripts for vignettes, revise the training content and scripts through the iterative process of reviews and revisions by engaging the provider advisory board and the subject matter experts, and record training modules in Zoom webinars. Rutgers Online Education Services will produce video clips for vignettes based on the scripts provided, edit the video clips and recorded Zoom webinars, and upload them into Canvas.

Phase 2: Assess the acceptability, appropriateness, and usability of the adapted DECIDE provider training to build new knowledge of DECIDE implementation in perinatal mental health practice: The investigators will recruit 35 perinatal and mental health providers, including nurses, midwives, primary care doctors, social workers, psychologists, case managers, counselors, peer specialists, and other obstetrics and gynecology care providers who provide mental health care to perinatal individuals within health systems. Health systems include hospitals and other healthcare organizations (e.g., home visit programs, State Medical Assistance and health services programs, Federally Qualified Health Centers).

The participants will take the adapted DECIDE provider training: To identify the acceptability, appropriateness, and usability of asynchronous DECIDE provider training modules, the Acceptability, Feasibility, and Appropriateness Scale (AFAS)42 developed for the assessment of implementation outcomes for training in EBPs will be used. The measure demonstrates a good fit to the hypothesized three-factor structures (RMSEA = .058, CFI = .990, TLI = .987) and acceptable internal consistency (α = .86 to α = .91).42 The AFAS uses a 5-point Likert scale with 1 indicating "not at all" and 5 indicating "extremely." A few examples of the items are: "To what extent are you satisfied with the training you received and the practices covered?", "How comfortable are you with the practices contained within the training?", "How well do the information and practices fit with your overall approach to service delivery and the setting in which you provide care?" AFAS has demonstrated sensitivity to assessing workshop-specific perceptions about training acceptability and feasibility.42 The online assessment of acceptability, appropriateness, and usability will be conducted immediately after and one month after the training. Considering that immediately measuring acceptability, appropriateness, and usability can increase the correlation between appropriateness and usability but less highly correlated post-implementation of an intervention as providers perceive usability differently once they actually use the skills taught,44 providers who complete the training will be asked to also participate in the one-month follow-up evaluation.

Open-ended questions will be added to obtain detailed information on user acceptability, appropriateness and feasibility. The example questions include: (1) Share your experience of taking the asynchronous online training regarding login, course navigation, module organization, and other aspects of accessing the training (2) Did the training change how participants interact with perinatal individuals with mental health disorders? What are the specific examples? (3) What are the best strategies to effectively implement the MOMs DECIDE provider training within your organization?

The investigators will conduct focus groups with the training participants one month after the training to gain an in-depth understanding of participants' perceptions of acceptability, appropriateness, and usability of the adapted DECIDE provider training and thoughts about strategies to promote the high-quality implementation of the DECIDE training. The focus group meetings will be held on the secure HIPPA-compliant Rutgers Zoom. The semi-structured topic guide will be used for structured stakeholder consultation/discussion: (1) What are the key facilitators and barriers to practicing DECIDE skills taught in perinatal mental health care? (2) What are the components that must be included or avoided in the DECIDE provider training to ensure that mental health providers in health systems use it as an SDM tool?, and (3) What are appropriate and acceptable strategies to implement the DECIDE provider training as part of the routine perinatal mental health care at participants' organization?

Being tested
MOMs DECIDE Provider Training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOMs DECIDE Provider TrainingBehavioural

    Participants will take an asynchronous online MOMs DECIDE provider training (approximately 2 hours). DECIDE stands for Decide the problem; Explore the questions; Closed or open-ended questions; Identify the who, why, or how of the problem; Direct questions to your health care professional; Enjoy a shared solution. The 5 modules will cover shared decision-making, perspective-taking, patient activation, attributional errors, and being a responsive provider to perinatal individuals.

Study groups in NCT07098260
Study groupRoleWhat they receive
Intervention ProvidersExperimentalThe intervention targets nurses, midwives, primary care doctors, social workers, psychologists, case managers, counselors, peer specialists, and other obstetrics and gynecology care providers who provide perinatal health, mental health and or behavioral health care in hospitals or other healthcare organizations (e.g., home visit programs, State Medical Assistance and health services programs, Federally Qualified Health Centers). These providers receive an asynchronous online training that teaches them to communicate more effectively with their perinatal mental health care patients in order to improve shared decision making.
Receives: Behavioral: MOMs DECIDE Provider Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability, Feasibility, and Appropriateness Scale (AFAS)

    The Acceptability, Feasibility, and Appropriateness Scale (AFAS)42 developed for the assessment of implementation outcomes for training in EBPs will be used. The measure demonstrates a good fit to the hypothesized three-factor structures (RMSEA = .058, CFI = .990, TLI = .987) and acceptable internal consistency (α = .86 to α = .91).42 The AFAS uses a 5-point Likert scale with 1 indicating "not at all" and 5 indicating "extremely." A few examples of the times are: "To what extent are you satisfied with the training you received and the practices covered?", "How comfortable are you with the practices contained within the training?", "How well do the information and practices fit with your overall approach to service delivery and the setting in which you provide care?" AFAS has demonstrated sensitivity to assessing workshop-specific perceptions about training acceptability and feasibility.42

    Measured: Immediately after and 1 month after the training

  2. Training Experience

    We will ask a set of open-ended questions to obtain detailed information on user acceptability, appropriateness and feasibility. The example questions include: (1) Share your experience of taking the asynchronous online training regarding login, course navigation, module organization, and other aspects of accessing the training (2) Did the training change how participants interact with perinatal individuals with mental health disorders? What are the specific examples? (3) What are the best strategies to effectively implement the MOMs DECIDE provider training within your organization?

    Measured: Immediately after the training

  3. Focus groups

    We will conduct focus groups with training participants one month after the training to gain an in-depth understanding of participants' perceptions of acceptability, appropriateness, and usability of adapted DECIDE and thoughts about strategies to promote the high-quality implementation of the DECIDE training.

    Measured: 1 month after the training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2025
  2. Study start14 Feb 2025
  3. Primary completion15 Jul 2026
  4. Study completion15 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
The MOMs DECIDE Provider Training will be adapted based on the DECIDE Provider Training model.10 Participants will take an asynchronous online MOMs DECIDE Provider Training (approximately 2 hours). DECIDE stands for Decide the problem; Explore the questions; Closed or open-ended questions; Identify the who, why, or how of the problem; Direct questions to your health care professional; Enjoy a shared solution. The 5 modules will cover shared decision-making, perspective-taking, patient activation, attributional errors, and being a responsive provider to perinatal individuals and include clinical illustrations developed for shared decision making in perinatal mental health care delivery.
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07098260
Sponsor's protocol ID
Pro2024002663
Status last verified
Oct 2026
First submitted
25 Jul 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alegria M, Nakash O, Johnson K, Ault-Brutus A, Carson N, Fillbrunn M, Wang Y, Cheng A, Harris T, Polo A, Lincoln A, Freeman E, Bostdorf B, Rosenbaum M, Epelbaum C, LaRoche M, Okpokwasili-Johnson E, Carrasco M, Shrout PE. Effectiveness of the DECIDE Interventions on Shared Decision Making and Perceived Quality of Care in Behavioral Health With Multicultural Patients: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Apr 1;75(4):325-335. doi: 10.1001/jamapsychiatry.2017.4585.

    PubMed 29466533
  • Kang-Yi CD, Nakash O. DECIDE for MOM Provider Training to improve healthcare providers' competency in engaging and communicating with perinatal individuals: protocol for a non-randomized feasibility study. Pilot Feasibility Stud. 2026 Jun 3. doi: 10.1186/s40814-026-01857-z. Online ahead of print.

    PubMed 42237371

Questions about this trial

What is this clinical trial studying?

A study testing MOMs DECIDE Provider Training in people with Mental Health Disorders, run by Rutgers, The State University of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability, Feasibility, and Appropriateness Scale (AFAS) (time frame: Immediately after and 1 month after the training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07098260, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in