Trial Outcomes & Findings for Prevention of Anhedonia in Children (NCT NCT05988138)
NCT ID: NCT05988138
Last Updated: 2026-07-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
Baseline, mid- and post-intervention
Results posted on
2026-07-09
Participant Flow
Enrollment numbers and number of participants Started/Completed represent the number of dyads (child and mother). Children and mothers enrolled and participated in the intervention together.
Participant milestones
| Measure |
Family Promoting Positive Emotions
An 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mother.
|
Psychoeducation
An 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
33
|
|
Overall Study
COMPLETED
|
33
|
31
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data show age of children and mothers.
Baseline characteristics by cohort
| Measure |
Family Promoting Positive Emotions - Child
n=40 Participants
An 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mothers.
|
Psychoeducation - Child
n=33 Participants
An 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources.
|
Family Promoting Positive Emotion - Mother
n=40 Participants
An 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mothers.
|
Psychoeducation - Mother
n=33 Participants
An 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
40 Participants
n=40 Participants • Data show age of children and mothers.
|
33 Participants
n=33 Participants • Data show age of children and mothers.
|
0 Participants
n=40 Participants • Data show age of children and mothers.
|
0 Participants
n=33 Participants • Data show age of children and mothers.
|
73 Participants
n=146 Participants • Data show age of children and mothers.
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=40 Participants • Data show age of children and mothers.
|
0 Participants
n=33 Participants • Data show age of children and mothers.
|
40 Participants
n=40 Participants • Data show age of children and mothers.
|
33 Participants
n=33 Participants • Data show age of children and mothers.
|
73 Participants
n=146 Participants • Data show age of children and mothers.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=40 Participants • Data show age of children and mothers.
|
0 Participants
n=33 Participants • Data show age of children and mothers.
|
0 Participants
n=40 Participants • Data show age of children and mothers.
|
0 Participants
n=33 Participants • Data show age of children and mothers.
|
0 Participants
n=146 Participants • Data show age of children and mothers.
|
|
Sex: Female, Male
Female
|
17 Participants
n=40 Participants • Data show sex of children and mothers.
|
14 Participants
n=33 Participants • Data show sex of children and mothers.
|
40 Participants
n=40 Participants • Data show sex of children and mothers.
|
33 Participants
n=33 Participants • Data show sex of children and mothers.
|
104 Participants
n=146 Participants • Data show sex of children and mothers.
|
|
Sex: Female, Male
Male
|
23 Participants
n=40 Participants • Data show sex of children and mothers.
|
19 Participants
n=33 Participants • Data show sex of children and mothers.
|
0 Participants
n=40 Participants • Data show sex of children and mothers.
|
0 Participants
n=33 Participants • Data show sex of children and mothers.
|
42 Participants
n=146 Participants • Data show sex of children and mothers.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=40 Participants • Data show race of children and mothers.
|
0 Participants
n=33 Participants • Data show race of children and mothers.
|
0 Participants
n=40 Participants • Data show race of children and mothers.
|
0 Participants
n=33 Participants • Data show race of children and mothers.
|
0 Participants
n=146 Participants • Data show race of children and mothers.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=40 Participants • Data show race of children and mothers.
|
2 Participants
n=33 Participants • Data show race of children and mothers.
|
1 Participants
n=40 Participants • Data show race of children and mothers.
|
2 Participants
n=33 Participants • Data show race of children and mothers.
|
5 Participants
n=146 Participants • Data show race of children and mothers.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=40 Participants • Data show race of children and mothers.
|
0 Participants
n=33 Participants • Data show race of children and mothers.
|
0 Participants
n=40 Participants • Data show race of children and mothers.
|
0 Participants
n=33 Participants • Data show race of children and mothers.
|
0 Participants
n=146 Participants • Data show race of children and mothers.
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=40 Participants • Data show race of children and mothers.
|
5 Participants
n=33 Participants • Data show race of children and mothers.
|
3 Participants
n=40 Participants • Data show race of children and mothers.
|
5 Participants
n=33 Participants • Data show race of children and mothers.
|
16 Participants
n=146 Participants • Data show race of children and mothers.
|
|
Race (NIH/OMB)
White
|
31 Participants
n=40 Participants • Data show race of children and mothers.
|
23 Participants
n=33 Participants • Data show race of children and mothers.
|
33 Participants
n=40 Participants • Data show race of children and mothers.
|
25 Participants
n=33 Participants • Data show race of children and mothers.
|
112 Participants
n=146 Participants • Data show race of children and mothers.
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=40 Participants • Data show race of children and mothers.
|
3 Participants
n=33 Participants • Data show race of children and mothers.
|
3 Participants
n=40 Participants • Data show race of children and mothers.
|
1 Participants
n=33 Participants • Data show race of children and mothers.
|
13 Participants
n=146 Participants • Data show race of children and mothers.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants • Data show race of children and mothers.
|
0 Participants
n=33 Participants • Data show race of children and mothers.
|
0 Participants
n=40 Participants • Data show race of children and mothers.
|
0 Participants
n=33 Participants • Data show race of children and mothers.
|
0 Participants
n=146 Participants • Data show race of children and mothers.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=40 Participants • Data show ethnicity of children and mothers.
|
3 Participants
n=33 Participants • Data show ethnicity of children and mothers.
|
2 Participants
n=40 Participants • Data show ethnicity of children and mothers.
|
2 Participants
n=33 Participants • Data show ethnicity of children and mothers.
|
9 Participants
n=146 Participants • Data show ethnicity of children and mothers.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=40 Participants • Data show ethnicity of children and mothers.
|
30 Participants
n=33 Participants • Data show ethnicity of children and mothers.
|
38 Participants
n=40 Participants • Data show ethnicity of children and mothers.
|
31 Participants
n=33 Participants • Data show ethnicity of children and mothers.
|
137 Participants
n=146 Participants • Data show ethnicity of children and mothers.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants • Data show ethnicity of children and mothers.
|
0 Participants
n=33 Participants • Data show ethnicity of children and mothers.
|
0 Participants
n=40 Participants • Data show ethnicity of children and mothers.
|
0 Participants
n=33 Participants • Data show ethnicity of children and mothers.
|
0 Participants
n=146 Participants • Data show ethnicity of children and mothers.
|
|
Neural responses to rewards (physiological measure) in children
|
3.53 µV
STANDARD_DEVIATION 6.44 • n=40 Participants • The reward positivity (RewP) component was measured in children only.
|
1.93 µV
STANDARD_DEVIATION 5.92 • n=33 Participants • The reward positivity (RewP) component was measured in children only.
|
—
|
—
|
2.81 µV
STANDARD_DEVIATION 6.22 • n=73 Participants • The reward positivity (RewP) component was measured in children only.
|
PRIMARY outcome
Timeframe: Baseline, mid- and post-interventionPopulation: Primary outcomes focus on children; the reward positivity (RewP) component was measured in children only.
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.
Outcome measures
| Measure |
Family Promoting Positive Emotions
n=33 Participants
An 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mother.
|
Psychoeducation
n=31 Participants
An 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources.
|
|---|---|---|
|
Neural Responses to Rewards (Physiological Measure) in Children
Mid-Intervention (4 weeks)
|
1.94 µV
Standard Deviation 5.54
|
1.39 µV
Standard Deviation 6.48
|
|
Neural Responses to Rewards (Physiological Measure) in Children
Post-Intervention (8 weeks)
|
1.43 µV
Standard Deviation 6.04
|
2.44 µV
Standard Deviation 4.65
|
Adverse Events
Family Promoting Positive Emotions - Child
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Psychoeducation - Child
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Family Promoting Positive Emotions - Mother
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Psychoeducation - Mother
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Family Promoting Positive Emotions - Child
n=40 participants at risk
An 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mother.
|
Psychoeducation - Child
n=33 participants at risk
An 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources.
|
Family Promoting Positive Emotions - Mother
n=40 participants at risk
An 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mother.
|
Psychoeducation - Mother
n=33 participants at risk
An 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation from EEG
|
0.00%
0/40 • Mothers and children were monitored for adverse events from enrollment until the end of the 8 week intervention
Adverse events were documented for both mother and child
|
3.0%
1/33 • Mothers and children were monitored for adverse events from enrollment until the end of the 8 week intervention
Adverse events were documented for both mother and child
|
0.00%
0/40 • Mothers and children were monitored for adverse events from enrollment until the end of the 8 week intervention
Adverse events were documented for both mother and child
|
0.00%
0/33 • Mothers and children were monitored for adverse events from enrollment until the end of the 8 week intervention
Adverse events were documented for both mother and child
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place