Testing "Doula Link", a Multi-Component Intervention to Improve Perinatal Mental Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBeth Israel Deaconess Medical Center
About this trial
Doulas are trained individuals who offer informational, emotional, and physical support to their pregnant, birthing, and postpartum clients. The goal of this clinical trial is to learn if a new intervention (called "Doula Link") is feasible to implement and acceptable to both doulas and their clients. The main questions it aims to answer are:
* Is Doula Link feasible to implement and acceptable to doulas and their clients? * What are the preliminary differences in depression and anxiety between individuals working with doulas who received Doula Link compared to those who did not receive Doula Link?
Researchers will compare "Doula Link" to usual doula practice to see if Doula Link is feasible and has potential to improve mental health outcomes in postpartum individuals.
Doulas will be randomly assigned to either receive "Doula Link" or continue with their practice as usual.
Participating doulas assigned to Doula Link will receive training mental health and implementing an intervention called "Our Babies and Us"; receive access to a toolkit; receive access to perinatal psychiatrists and referral specialists for consultations; receive access to a support group
All participating doulas will be invited to complete surveys about their experience with Doula Link (if assigned to that group) and their experience providing care for their clients.
All participating clients (pregnant and postpartum individuals) will be invited to complete surveys about their experiences with their doulas, their own mental health, and their experiences with the health system.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
For doulas: currently providing prenatal or postpartum support to at least one client; plant to provide prenatal or postpartum support to at least three clients in the next six months; work in Massachusetts; did not participate in development of the intervention; available to participate in in-person training; English language fluency
For clients: Pregnant or no more than 12 weeks postpartum at enrollment; served by one of the 30 study doulas; live in, and plan to give birth in Massachusetts; fluency in either English or Spanish
Disqualifiers
Not meeting inclusion criteria
Trial design
Design model
Parallel
Treatments tested in this trial
Doula Link
Behavioral1\) a doula-specific mental health toolkit; 2) training to implement an evidence-based, stress-reduction program called Our Babies and Us; 3) training for, and access to expert consultations with perinatal psychiatric specialists through MCPAP for Moms; 4) training on perinatal mental health; 5) access to doula support groups
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Doula LinkExperimental treatment 1 intervention
Group B: Doula Support as UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Acceptability of Intervention Measure
Perception among postpartum individuals in the Doula Link arm that Doula Link is agreeable and perception among postpartum individuals in the Doula Link arm that Doula Link and its individual components is agreeable. The "Acceptability of Intervention Measure (AIM) will be used. This is a four-question scale scored on a range from 1-5 with higher values indicating better acceptability.
Time frame
32-weeks gestation and 6 weeks postpartum postpartum for clients. Directly following, 6-months after, and 12-months after training for doulas.2
Feasibility of Intervention
How well Doula Link and its individual components can be successfully delivered to doulas. The "Feasibility of Intervention Measure" (FIM) will be used. This is a four-question scale scored on a range from 1-5 with higher values indicating better feasibility.
Time frame
Directly following, 6-months after, and 12-months after doula trainingSecondary outcomes
1
Appropriateness of Intervention
The perceived fit and relevance of Doula Link and its individual components among doulas and their clients in the Doula Link arm. The "Appropriateness of Intervention Measure" (IAM) will be used. This is a four-question scale scored on a range from 1-5 with higher values indicating better appropriateness.
Time frame
32-weeks gestation and 6 weeks postpartum for clients. Directly following, 6-months after, and 12-months after training for doulas.2
Fidelity of implementation of Our Babies and Us
The degree to which the Our Babies and Us component of Doula Link is implemented by the doulas to each client. This will be measured using the Our Babies and Us fidelity scale, which measures each topic across three dimensions. Possible scores range from 0 to 6 with higher scores indicating higher fidelity.
Time frame
Every two weeks after client enrollment for a total of six time points.3
Reach of Our Babies and Us component
The proportion of clients who receive part or all of the Our Babies and Us component of the intervention.
Time frame
At 6 weeks postpartum4
Symptoms of depression
Client scores on the Edinburgh Postnatal Depression Scale (EPDS). Possible range of scores is 0 to 30 with higher scores indicating a worse outcome.
Time frame
32-weeks gestation, 6-weeks postpartum, and 16-weeks postpartumOther outcomes
1
Help-seeking
Clients scores on the barriers to access to care evaluation scale (BACE). The possible range of scores on the BACE is 0 to 90 with higher scores indicating a worse outcome, i.e. more barriers to access to care.
Time frame
32-weeks gestation and 6- and 16-weeks postpartum2
Treatment participation
Proportion of individuals who have symptoms of depression (denominator) who report accessing treatment (numerator) in the past six weeks. Denominator is defined as a score of 10 or higher on the Edinburgh Postpartum Depression Scale (EPDS), indicating any thoughts of self-harm on the EPDS, or having been diagnosed with depression by a clinician. Numerator is defined as having seen a mental health professional or been prescribed medication to treat a perinatal mental health disorder.
Time frame
32-weeks gestation and 6- and 16-weeks postpartum3
Skills used
Our babies and us stress reduction skill used. The "Mothers and Babies Skills Utilization Scale" will be used. This 11-item scale assesses aspects of skills using a five-point frequency Likert scale. The full scale has a possible range of 0 to 44 with higher scores indicating a better outcome, i.e. more skills used.
Time frame
32-weeks gestation, 6-weeks postpartum, and 16-weeks postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beth Israel Deaconess Medical Center
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov