CompletedNot Applicable

Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development

United States368 participantsStarted 2018-02-15

Plain-language summary

A mobile remote coaching program study to improve maternal mood and increase parenting practices that lead to better infant social-emotional and communication outcomes

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Mother is 18 years of age * Mother speaks English * Mother lives in metro-Atlanta area * Mother has baby younger than 12 months of age * Mother has positive depression screen (PHQ2) Exclusion Criteria: Stressors that mother specifies at the time of screening that would interfere with study participation such as: maternal homelessness, mental or physical health condition (diagnosed with schizophrenia or treatment/medication for hallucinations/delusions), current inpatient treatment for mental health or substance abuse. Infant exclusion criteria include factors that could render research participation stressful, such as intensive treatment for a genetic or health condition or not in permanent legal guardian custody

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PHQ9

Timeframe: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

Landry Parent Child Interaction Rating Scales - Mother Positive Behavior

Timeframe: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

Landry Parent Child Interaction Rating Scales - Mother Negative Behavior

Timeframe: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior

Timeframe: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend

Timeframe: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

Trial details

NCT IDNCT03464630

SponsorGeorgia State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-01

Results submitted2023-11-21

View on ClinicalTrials.gov More Maternal Depression and Parent Practices, Postpartum trials