AnhedoniaNCT05988138
Prevention of Anhedonia in Children
A study testing Family Promoting Positive Emotions and Psychoeducation in people with Anhedonia and Depression, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Anhedonia, Depression
- What is being tested?
- Family Promoting Positive Emotions and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2023to 17 Jan 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reward Responsiveness as a Prevention Target in Youth At Risk for Anhedonia
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.
Read the 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.
- Conditions
- Anhedonia, Depression
- Being tested
- Family Promoting Positive Emotions, Psychoeducation
- Medical subject headings
- Anhedonia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Promoting Positive EmotionsBehavioural
An 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mothers
PsychoeducationBehavioural
An 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources
| Study group | Role | What they receive |
|---|---|---|
| Family Promoting Positive Emotions | Experimental | Not described Receives: Behavioral: Family Promoting Positive Emotions |
| Psychoeducation | Active comparator | Not described Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural Responses to Rewards (Physiological Measure) in Children
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.
Measured: Baseline, mid- and post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start10 Nov 2023
- Primary completion17 Jan 2026
- Study completion17 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnhedoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital, Penn State University
- Responsible party
- Principal investigator, Autumn Kujawa, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988138
- Sponsor's protocol ID
- 230616
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2023
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared through the National Institute of Mental Health Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reward Responsiveness as a Prevention Target in Youth At Risk for Anhedonia
- ClinicalTrials.gov ID
- NCT05988138
- Acronym / sponsor ID
- 230616
- Conditions
- Anhedonia, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital, Penn State University
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 17 Jan 2026 (actual)
- Study completion
- 17 Jan 2026 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Posted 9 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Promoting Positive Emotions | Experimental | Behavioral: Family Promoting Positive Emotions |
| Psychoeducation | Active comparator | Behavioral: Psychoeducation |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Promoting Positive EmotionsAn 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mothers | Behavioural | Family Promoting Positive Emotions |
| PsychoeducationAn 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources | Behavioural | Psychoeducation |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be shared through the National Institute of Mental Health Data Archive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Promoting Positive Emotions and Psychoeducation in people with Anhedonia and Depression, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural Responses to Rewards (Physiological Measure) in Children (time frame: Baseline, mid- and post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.