Prevention of Anhedonia in Children

July 8, 2026 updated by: Autumn Kujawa, Vanderbilt University

Reward Responsiveness as a Prevention Target in Youth At Risk for Anhedonia

This trial will test the effects of a positive emotion-focused preventive intervention on reward responsiveness in children of mothers with histories of depression and anhedonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will test the effects of a dyadic preventive intervention, Family Promoting Positive Emotion (F-PPE), for 8- to 12-year-old children of mothers with a history of major depressive disorder (MDD) with anhedonia. The study will first test F-PPE effects on child reward responsiveness (R61), and pending evidence of target engagement, effects on real-world experience of interest/pleasure and clinical symptoms of anhedonia will be evaluated in a second, larger clinical trial (R33). F-PPE was designed to increase child positive valence systems function through mother-child training in behavioral and cognitive skills to increase pleasant activities and attention towards/savoring the positive, individual and dyadic goals, and skills practice. For the R61 phase, eligible child participants (N=60 intervention completers) will complete an EEG assessment of neural reward responsiveness pre- and post-intervention, as well as halfway through the intervention (4 weeks) to determine dose effects. Children and their biological mothers will be randomly assigned to 8 sessions of F-PPE or a psychoeducation comparison condition (groups will be matched on child sex and baseline RewP). Both interventions will be administered through individual telehealth sessions with a masters- or doctoral-level clinician under the supervision of the PIs. To ensure treatment fidelity, videotaped sessions will be reviewed for adherence to the protocol, clinicians will participate in weekly group supervision, and supervisors will randomly review recorded sessions for ratings of treatment adherence.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Jesup/Hobbs Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Biological mothers with past or current MDD with anhedonia and their 8- to 12-year-old children
  • Child and biological mother can read and speak fluently in English
  • Child and mother have access to a computer or tablet and internet for videoconferencing
  • For compensation purposes, child and biological mothers must be U.S. citizens

Exclusion Criteria:

  • Children with past or current major depressive disorder (MDD) and/or anhedonia lasting most of the day, nearly every day for at least 2 weeks based on semi-structured interviews will be excluded
  • Mothers or children with intellectual or developmental disabilities
  • Mothers with past 6 months substance use disorder with moderate or greater severity
  • Children or mothers with a lifetime history of a manic or hypomanic episode/bipolar disorder
  • Children or mothers with a psychotic disorder (e.g., schizophrenia)
  • Children or mothers with visual or hearing impairments that interfere with completing study measures and sessions
  • Child offspring of a mother who has previously participated in the study with another biological child
  • Children taking medications for emotional or behavioral problems other than SSRIs (stable dose for 6 weeks before time of enrollment) or psychostimulants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Psychoeducation
Behavioral: Psychoeducation
An 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources
Experimental: Family Promoting Positive Emotions
Behavioral: Family Promoting Positive Emotions
An 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mothers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neural responses to rewards measured by electroencephalogram (EEG) in a computerized guessing reward task (physiological measure)
Time Frame: 4 and 8 weeks
The reward positivity (RewP) component will be measured using EEG with an established computerized guessing reward task ("Doors" task). EEG data will be processed using best practices and the RewP component will be exported from the EEG data approximately 250-350 ms after feedback presentation at the electrode Cz. RewP scores will be quantified as the relative neural response to reward vs. loss feedback.
4 and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

Nationwide Children's Hospital
Penn State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2023

Primary Completion (Actual)

January 17, 2026

Study Completion (Actual)

January 17, 2026

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared through the National Institute of Mental Health Data Archive

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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