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Social Support Therapy for Postpartum Depression (ASSET-PPD Trial)
N/A
Waitlist Available
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administered at 1-, 3-, and 6-months
Awards & highlights
ASSET-PPD Trial Summary
This trial examines a therapy that trains fathers of prenatal depression sufferers to help reduce maternal stress and improve the family environment.
Who is the study for?
This trial is for African-American couples where the mother is in her 2nd trimester, experiencing depression with significant symptoms, and receiving psychiatric treatment. Fathers must be over 18 and able to focus on an hour of instruction. Couples don't need to be romantically involved but can't join if there's abuse, plans to end the pregnancy, or recent psychosis or substance use by the woman.Check my eligibility
What is being tested?
The ASSET-PPD program aims to train fathers in supporting mothers with prenatal depression. It focuses on enhancing paternal support within the family environment to alleviate maternal stress during perinatal periods and improve outcomes for infants.See study design
What are the potential side effects?
Since this intervention involves educational support rather than medication, typical medical side effects are not expected. However, participants may experience emotional discomfort discussing personal issues during sessions.
ASSET-PPD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3- and 6-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3- and 6-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maternal anxiety
Maternal depression
Secondary outcome measures
Breastfeeding
Infant affect and mood regulation
Parent-infant interaction quality
ASSET-PPD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ASSET-PPD intervention groupExperimental Treatment1 Intervention
25 parent dyads with a mother who is receiving individual treatment outside of the study and the father is receiving the ASSET-PPD training
Group II: No additional treatment groupActive Control1 Intervention
25 parent dyads with a mother who is receiving individual treatment outside of the study and the father is not receiving the ASSET-PPD training
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,131 Total Patients Enrolled
8 Trials studying Postpartum Depression
2,050 Patients Enrolled for Postpartum Depression
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Eligibility for the study requires a pregnant woman to be African-American, in her 2nd trimester of pregnancy and receiving psychiatric treatment with an Inventory of Depressive Symptoms-Self-Rated (IDS-SR16) score of 11 or greater, indicating clinically significant symptoms.Eligibility is not limited to parents in a romantic relationship; infants aged 0-6 months can also participate for the purpose of examining parent-infant interactions.Your parents are of legal age, at least 18 years old.Parents will not be allowed to participate if there is evidence of physical or sexual abuse, if they plan to end the pregnancy, or if the woman has shown signs of mental health issues or substance abuse in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: ASSET-PPD intervention group
- Group 2: No additional treatment group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings available for prospective participants of this experiment?
"The clinical trial, which was initially published on August 27th 2020, remains open for enrolment according to information hosted by clinicaltrials.gov and has been modified as recently as February 27th 2023."
Answered by AI
How many individuals have registered for participation in this clinical examination?
"Affirmative. According to clinicaltrials.gov, this trial which was launched on August 27th 2020 is actively seeking applicants for enrollment. The study needs 100 individuals from a sole medical centre in order to move forward with the research process."
Answered by AI
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