Prevention of Anhedonia in Children

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: Depression; Anhedonia
• Intervention / Treatment: Behavioral: Family Promoting Positive Emotions; Behavioral: Psychoeducation

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, 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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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

• Sponsor: Vanderbilt University
• Collaborators: Nationwide Children's Hospital

Study record dates

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): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Behavioral Symptoms; Neurobehavioral Manifestations; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Depression; Anhedonia
• 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