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Completed

NCT Number: NCT05988138

Prevention of Anhedonia in Children

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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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jesup/Hobbs Building

Nashville, Tennessee, 37203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family Promoting Positive Emotions

Behavioral

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

Psychoeducation

Behavioral

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

Primary outcomes

  1. Neural Responses to Rewards (Physiological Measure) in Children

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Nationwide Children's Hospital
  • Penn State University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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