Prevention of Anhedonia in Children

NCT ID: NCT05988138

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-10
• Study Completion Date: 2026-01-31

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.

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.

Conditions

Anhedonia; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Family Promoting Positive Emotions

Group Type: EXPERIMENTAL

Family Promoting Positive Emotions

Intervention Type: BEHAVIORAL

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

Psychoeducation

Group Type: ACTIVE_COMPARATOR

Psychoeducation

Intervention Type: BEHAVIORAL

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

Interventions

Family Promoting Positive Emotions

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

Intervention Type: BEHAVIORAL

Psychoeducation

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Autumn Kujawa

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jesup/Hobbs Building

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

230616

Identifier Type: -

Identifier Source: org_study_id