Maternal Perinatal DepressionASSET-PPDNCT05762133
African-American Social Support Effectiveness Treatment
A study testing African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD) in people with Maternal Perinatal Depression, run by Northwestern University at 1 site in United States.
Trial summary
The objective of this treatment study is to develop and test an augmentation therapy in conjunction with maternal psychiatric treatment that targets the fathers' support of the mothers' mental health and contributions to the family environment to reduce maternal stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maternal Perinatal Depression
- What is being tested?
- African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2020to 31 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parents will be 18 years of age or older.
- Parents are eligible for the study if the woman is in the 2nd trimester, she is receiving psychiatric treatment for depression with a score of 11 or greater on the Inventory of Depressive Symptoms-Self-Rated (IDS-SR16), which indicates clinically significant symptoms, and the mother is African-American
- Parents do not need to be romantic partners to be eligible. Infants (0-6 months) are included in the study to examine the parent-infant interactions
Who cannot join
- The parents will be excluded if:
- There is report of ongoing physical or sexual abuse
- They have plans to terminate the pregnancy
- The woman is showing symptoms of hypomania/mania, psychosis, or substance use in the past 12 months
- Father will be excluded if he:
- Has symptoms of psychosis in the past 12 months
- Has below 6th grade education
- Has difficulty focusing on 1 hour of instruction
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: African-American Social Support Effectiveness Treatment-Partners Alleviating Perinatal Depression
The objective of this treatment study is to develop and test an augmentation therapy in conjunction with maternal psychiatric treatment that targets the fathers' support of the mothers' mental health and contributions to the family environment to reduce maternal stress. The African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD) intervention will be delivered to fathers in an individual setting to target the context in which a mother lives to expand her support beyond the direct reach of her treatment professional. This study provides skills and training to fathers who have a partner with prenatal depression. The aim is to reduce maternal depression during the perinatal period and improve the family environment for the infant.
Read the detailed description
African-American (AA) mothers have a higher risk for perinatal depression than Caucasian women that is attributable to increased socio-environmental stressors. In addition, AA women have poor healthcare utilization and compliance with psychiatric treatment compared to Caucasian women. An intervention is required to supplement and support the clinical objectives of the mother's depression care without requiring the mother's direct involvement. Fathers are an underutilized resource to reduce the mother's environmental stress and encourage healthy maternal behaviors. The African-American Social Support Effectiveness Treatment- Partners alleviating Perinatal Depression (ASSET-PPD) protocol will target the fathers' support of the mothers' mental health treatment and their active engagement in the family to reduce maternal stress. The ASSET-PPD intervention will be designed to have 4 active modules that address key factors to reduce maternal stress during the prenatal period and 2 postpartum review sessions. The modules will be individual sessions constructed to provide training, information, and behavioral assignments to increase fathers': 1) prenatal and postpartum family involvement; 2) mental health psychoeducation; 3) interparental communication and relationship skills; and 4) balanced division of family tasks. ASSET-PPD will be evaluated in a pilot Randomized Clinical Trial (RCT) with 50 cohabitating or non-cohabitating fathers and AA mothers who will be randomized into the ASSET-PPD intervention or the comparator group. Fathers only will participate in the intervention, and mothers and fathers will complete measures of mental health and parental experiences. Maternal depressive symptoms will be assessed as a primary outcome, and breastfeeding and parent-infant interactions will be assessed as secondary outcomes.
- Conditions
- Maternal Perinatal Depression
- Being tested
- African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD)
- Keywords
- perinatal depression, postpartum depression, anxiety, fathers, partners, parents, African American, social support
- Medical subject headings
- Depression, Postpartum, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD)Behavioural
This proposed novel intervention has four prenatal modules and two postpartum review sessions addressing key correlates of Perinatal Depression (PND) with the largest effect sizes by targeting fathers': 1) prenatal and postpartum family involvement; 2) mental health psychoeducation; 3) interparental communication and relationship skills; and 4) balanced division of family tasks. The intervention is based on the stress-generation and cognitive-behavior theories to frame skill-based individual sessions of didactics, interactive training, and trackable objectives.
| Study group | Role | What they receive |
|---|---|---|
| ASSET-PPD intervention group | Experimental | 25 parent dyads with a mother who is receiving individual treatment outside of the study and the father is receiving the ASSET-PPD training Receives: Behavioral: African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD) |
| No additional treatment group | No 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal depression
The Inventory of Depressive Symptoms-Self-Rated (IDS-SR16) is a 16-item self-report measure of depressive symptoms. Minimum value: 0, Maximum value: 3, Higher scores indicate worse outcome
Measured: Second trimester through six month postpartum
Maternal anxiety
The Generalized Anxiety Disorder-7-item (GAD-7) is a 7-item, self-report measure assesses the dimension of generalized anxiety. Minimum value: 0, Maximum value: 3, Higher scores indicate worse outcome
Measured: Second trimester through six month postpartum
Secondary outcomes (3)
Breastfeeding
The FeedCat Tool (FT) is a 9-item self-report breastfeeding assessment that measures the type, amount, and mode of feeding. FT complies with the World Health Organization (WHO) and Centers for Disease Control (CDC) recommendations
Measured: Administered at 1-, 3-, and 6-months
Infant affect and mood regulation
The Infant Behavior Questionnaire- Revised (IBQ-R) is a 36-item parent-report measure of infant behaviors (positive/negative affect, regulation), Minimum value: 0, Maximum value: 7, Higher scores indicate greater level of temperament dimension of the 14 scales
Measured: Administered at 1-, 3-, and 6-months
Parent-infant interaction quality
Mothers and fathers will attend an onsite observation that includes a 5-minute free play with their infant separately and a 5-minute free play together as co-parents. Parent-infant interactions will be videotaped by a split-screen Noldus Media Recorder. Interaction quality will be coded on the Parent-Child Early Relational Assessment (PCERA). PCERA is a valid, reliable measure of the quality of affect and behavior in parent-child interactions and has been used in psychiatric studies and triadic interactions. Minimum value: 1, Maximum value: 5, Higher scores indicate better outcomes
Measured: At 3- and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start27 Aug 2020
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Perinatal DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We plan to enroll 50 parent dyads (100 individuals total, 25 romantic or non-romantic partners per arm). If we assume 5% attrition at each phase, we anticipate analyzable data for between 20-25 parent duos per arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheehan David Fisher, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762133
- Sponsor's protocol ID
- 1R21MD014798-01A1
- Acronym
- ASSET-PPD
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- African-American Social Support Effectiveness Treatment-Partners Alleviating Perinatal Depression
- ClinicalTrials.gov ID
- NCT05762133
- Acronym / sponsor ID
- ASSET-PPD / 1R21MD014798-01A1
- Conditions
- Maternal Perinatal Depression
- Keywords
- perinatal depression, postpartum depression, anxiety, fathers, partners, parents, African American, social support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this treatment study is to develop and test an augmentation therapy in conjunction with maternal psychiatric treatment that targets the fathers' support of the mothers' mental health and contributions to the family environment to reduce maternal stress. The African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD) intervention will be delivered to fathers in an individual setting to target the context in which a mother lives to expand her support beyond the direct reach of her treatment professional. This study provides skills and training to fathers who have a partner with prenatal depression. The aim is to reduce maternal depression during the perinatal period and improve the family environment for the infant.
Detailed description
African-American (AA) mothers have a higher risk for perinatal depression than Caucasian women that is attributable to increased socio-environmental stressors. In addition, AA women have poor healthcare utilization and compliance with psychiatric treatment compared to Caucasian women. An intervention is required to supplement and support the clinical objectives of the mother's depression care without requiring the mother's direct involvement. Fathers are an underutilized resource to reduce the mother's environmental stress and encourage healthy maternal behaviors. The African-American Social Support Effectiveness Treatment- Partners alleviating Perinatal Depression (ASSET-PPD) protocol will target the fathers' support of the mothers' mental health treatment and their active engagement in the family to reduce maternal stress. The ASSET-PPD intervention will be designed to have 4 active modules that address key factors to reduce maternal stress during the prenatal period and 2 postpartum review sessions. The modules will be individual sessions constructed to provide training, information, and behavioral assignments to increase fathers': 1) prenatal and postpartum family involvement; 2) mental health psychoeducation; 3) interparental communication and relationship skills; and 4) balanced division of family tasks. ASSET-PPD will be evaluated in a pilot Randomized Clinical Trial (RCT) with 50 cohabitating or non-cohabitating fathers and AA mothers who will be randomized into the ASSET-PPD intervention or the comparator group. Fathers only will participate in the intervention, and mothers and fathers will complete measures of mental health and parental experiences. Maternal depressive symptoms will be assessed as a primary outcome, and breastfeeding and parent-infant interactions will be assessed as secondary outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We plan to enroll 50 parent dyads (100 individuals total, 25 romantic or non-romantic partners per arm). If we assume 5% attrition at each phase, we anticipate analyzable data for between 20-25 parent duos per arm.
| Arm | Type | Receives |
|---|---|---|
| ASSET-PPD intervention group | Experimental | Behavioral: African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD)25 parent dyads with a mother who is receiving individual treatment outside of the study and the father is receiving the ASSET-PPD training |
| No additional treatment group | No 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parents will be 18 years of age or older.
- Parents are eligible for the study if the woman is in the 2nd trimester, she is receiving psychiatric treatment for depression with a score of 11 or greater on the Inventory of Depressive Symptoms-Self-Rated (IDS-SR16), which indicates clinically significant symptoms, and the mother is African-American
- Parents do not need to be romantic partners to be eligible. Infants (0-6 months) are included in the study to examine the parent-infant interactions
Key exclusion criteria (8 listed)
- There is report of ongoing physical or sexual abuse
- They have plans to terminate the pregnancy
- The woman is showing symptoms of hypomania/mania, psychosis, or substance use in the past 12 months
- Has symptoms of psychosis in the past 12 months
- Has below 6th grade education
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD)This proposed novel intervention has four prenatal modules and two postpartum review sessions addressing key correlates of Perinatal Depression (PND) with the largest effect sizes by targeting fathers': 1) prenatal and postpartum family involvement; 2) mental health psychoeducation; 3) interparental communication and relationship skills; and 4) balanced division of family tasks. The intervention is based on the stress-generation and cognitive-behavior theories to frame skill-based individual sessions of didactics, interactive training, and trackable objectives. | Behavioural | ASSET-PPD intervention group |
Primary outcome
Maternal depression
Time frame: Second trimester through six month postpartum
The Inventory of Depressive Symptoms-Self-Rated (IDS-SR16) is a 16-item self-report measure of depressive symptoms. Minimum value: 0, Maximum value: 3, Higher scores indicate worse outcome
Maternal anxiety
Time frame: Second trimester through six month postpartum
The Generalized Anxiety Disorder-7-item (GAD-7) is a 7-item, self-report measure assesses the dimension of generalized anxiety. Minimum value: 0, Maximum value: 3, Higher scores indicate worse outcome
3 secondary outcomes
Breastfeeding
Time frame: Administered at 1-, 3-, and 6-months
Infant affect and mood regulation
Time frame: Administered at 1-, 3-, and 6-months
Parent-infant interaction quality
Time frame: At 3- and 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD) in people with Maternal Perinatal Depression, run by Northwestern University 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 8 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 3 Mar 2025. 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?
Maternal depression (time frame: Second trimester through six month postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2025.