CompletedNot Applicable

Family Promoting Positive Emotions Pilot Study

United States74 participantsStarted 2021-12-01

Plain-language summary

Anhedonia is characterized by loss of interest or pleasure. The proposed pilot study would be the first to test an innovative, neuroscience-informed intervention in mothers reporting depressive symptoms and stress to enhance positive emotionality with the goal of preventing anhedonia and associated emotional disturbances in their children. This study will recruit dyads (mothers and their children) for the intervention.

Who can participate

Age range

8 Years

Sex

ALL

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 for mothers: * Age 18 and older who report at least subthreshold current depressive symptoms (\> score of 8 on the Patient Health Questionnaire) and moderate COVID-19-related stress * Can read and speak in English. * Have access to a computer with a videoconferencing platform. Inclusion criteria for children: * Age 8-12 years who can participate with their biological mother who is 18 years or older that meets the above criteria. * Can read and speak in English. Exclusion criteria for mothers: * Current substance use disorder. * Intellectual disabilities. * Diagnosis of mania or bipolar disorder. * Diagnosis of a psychotic disorder (e.g., schizophrenia). * Visual or hearing impairments that interfere with completing study measures and sessions. Exclusion criteria for children: * Diagnoses of autism spectrum disorders or developmental disorders. * Intellectual disabilities. * Diagnosis of mania or bipolar disorder. * Diagnosis of a psychotic disorder (e.g., schizophrenia). * Currently experiencing depressive symptoms. * Visual or hearing impairments that interfere with completing study measures and sessions. * Offspring of mothers who have previously participated in the study with another biological child.

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

Child perceived stress

Timeframe: 8 weeks

Child emotional distress

Timeframe: 8 weeks

Child positive affect

Timeframe: 8 weeks

Trial details

NCT IDNCT05223842

SponsorVanderbilt University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-20

View on ClinicalTrials.gov More Depression trials

Plain-language summary

Who can participate

Age range

8 Years

Sex

ALL

See this in plain English?

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