Prevention of Anhedonia in Children

NCT05988138 | Completed DMC

• 1 other identifier: 230616
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Anhedonia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Family Promoting Positive Emotions

EXPERIMENTAL

Behavioral: Family Promoting Positive Emotions

Psychoeducation

ACTIVE COMPARATOR

Behavioral: Psychoeducation

Interventions

Psychoeducation BEHAVIORAL

An 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources

Psychoeducation

Family Promoting Positive Emotions BEHAVIORAL

An 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mothers

Family Promoting Positive Emotions

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• Nationwide Children's Hospital: collaborator

Study Sites (1)

Jesup/Hobbs Building

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Anhedonia; Depression

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 14, 2023
• Study Start: November 10, 2023
• Primary Completion: January 17, 2026
• Study Completion: January 17, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)