Clinical Trial: Prevention of Anhedonia in Children

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

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

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 Summary: 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.
Sponsor: Vanderbilt University

Current Primary Outcome: 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.

Original Primary Outcome: 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.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Vanderbilt University

Dates:
Date Received: July 27, 2023
Date Started: November 10, 2023
Date Completion: November 10, 2023
Last Updated: November 13, 2023
Last Verified: November 01, 2023