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Prevention of Anhedonia in Children

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05988138
Enrollment
73
Registered
2023-08-14
Start date
2023-11-10
Completion date
2026-01-17
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anhedonia, Depression

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 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.

Interventions

BEHAVIORALFamily Promoting Positive Emotions

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

BEHAVIORALPsychoeducation

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

Sponsors

Vanderbilt University
Lead SponsorOTHER
Nationwide Children's Hospital
CollaboratorOTHER
Penn State University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026