Jesup/Hobbs Building
Nashville, Tennessee, 37203, United States
NCT Number: NCT05988138
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.
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Notify Me8 year–12 year
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37203, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mothers
An 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources
Time frame: Baseline, mid- and post-intervention
The primary outcome was neural reward responsiveness in children. The reward positivity (RewP) component was measured in children using EEG with an established computerized guessing reward task ("Doors" task). EEG data were processed using best practices and the RewP component was exported from the EEG data approximately 250-350 ms after feedback presentation at the electrode Cz. RewP scores are quantified as the relative neural response to reward vs. loss feedback (response to win minus response to loss). Smaller RewP values (less differentiation in responses to reward vs loss) are considered blunted and thought to be associated with increased anhedonia risk.
Vanderbilt University
Other
Reward Responsiveness as a Prevention Target in Youth At Risk for Anhedonia
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