Trials / Completed
CompletedNCT05988138
Prevention of Anhedonia in Children
Reward Responsiveness as a Prevention Target in Youth At Risk for Anhedonia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- Vanderbilt University · Academic / Other
- Sex
- All
- Age
- 8 Years – 12 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Family Promoting Positive Emotions | An 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mothers |
| BEHAVIORAL | Psychoeducation | An 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources |
Timeline
- Start date
- 2023-11-10
- Primary completion
- 2026-01-17
- Completion
- 2026-01-17
- First posted
- 2023-08-14
- Last updated
- 2026-03-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05988138. Inclusion in this directory is not an endorsement.