DepressionPEACHYNCT06725160
Parent Encouragement And Coaching of Happiness in Youth
A study testing Parent Coaching in people with Depression and Parent-Child Relations, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of this mechanistic clinical trial is to examine whether parent-coaching aimed at increasing child positive affect will increase child neural response to reward. The main questions it aims to answer are: Aim 1. Read more about this study
- Who is it for?
- Ages 4 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Parent-Child Relations
- What is being tested?
- Parent Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2025to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Birth mother (biologically female, any gender)
- Providing regular care for participating child (i.e., at least 50% of time)
- Elevated, clinically significant levels of depression (16 or higher on CES-D)
- Aged 18+
- -Aged 4-6 years
Who cannot join
- Lifetime history of a bipolar disorder
- Lifetime history of a psychotic disorder
- T-score greater than 63 on the internalizing or externalizing composites of the CBCL
- Lifetime history of a psychiatric illness
- Lifetime history of neurodevelopmental disorder
- Lifetime history of neurological disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Lauren M Bylsma, PhD, 412-624-8363, BylsmaL@pitt.edu
Judith K Morgan, PhD, 412-383-5454, jkm46@pitt.edu
About this study
Official title: Maternal Positive Affect Socialization and Child Neural Reward Response
The goal of this mechanistic clinical trial is to examine whether parent-coaching aimed at increasing child positive affect will increase child neural response to reward. The main questions it aims to answer are:
Aim 1. Characterize child neural reward response and its relation to maternal socialization of positive emotions at baseline in healthy young children.
Read more
Aim 2. Evaluate how coaching-related changes in maternal socialization of positive emotion expression contribute to increases in child neural reward response over time.
Aim 3. Examine how maternal socialization of positive emotion expression contributes to increases in child neural reward response in the moment.
Participating mother-child dyads will be randomized to either 3 sessions of parent coaching of child positive affect or 3 sessions of a general parenting support intervention and neural response to reward and affective behavior will be examined pre and post intervention.
Read the detailed description
Reward-related brain function is consistently linked to greater motivation, pleasure, and goal-directed behavior and lower risk for depression across the lifespan. Healthy neural reward response supports socioemotional development, particularly during early childhood as self-regulatory skills and child reward-related brain function are rapidly developing in the context of the caregiving environment. Maternal socialization of positive emotion is one important influence on early reward circuitry development. Mothers with depression are more likely to discourage (and less likely to encourage) child positive emotions compared to healthy mothers, which may contribute to early neural reward alterations in their children. Characterizing mechanisms of influence of maternal socialization on child neural reward response and positive emotion during early childhood is a critical window of opportunity when parents have a large influence on child socioemotional development. Importantly, maternal behavior is amenable to change by training parents on emotion coaching, and these maternal behavior changes may result in direct and immediate changes in child neural reward function. Thus, the overarching aim of this proposal is to use a mechanistic trial design to experimentally test the hypothesis that maternal encouragement of child positive emotion will lead to in-vivo increases in child neural reward response. Event-related potentials (ERPs) are uniquely suited to non-invasively assess in-vivo, fast-occurring changes in child reward response during parent-child interactions, including reward positivity (RewP), and the late positive potential (LPP) amplitudes. Toward this aim, the investigators will randomize 180 mothers with clinically significant depression symptoms and their 4- to 6-year-old children (50% female) to receive either 3 control sessions or 3 positive emotion coaching modules from the Parent-Child Interaction Therapy-Emotion Development (PCIT-ED, which trains mothers on how to encourage positive emotion in their young children. Children will complete reward tasks at pre- and post-coaching, while neural reward response is assessed via ERP (RewP and LPP) with their mothers present allowing for in-vivo assessment of maternal behavior. At both timepoints, the investigators will assess child neural reward response and mothers' self-reported maternal socialization behaviors. Understanding how disrupted neural reward responding develops in early childhood is critical for the promotion of child emotional wellness and can be directly used to develop preventive interventions tailored to young children at familial risk for depression.
- Conditions
- Depression, Parent-Child Relations
- Being tested
- Parent Coaching, Active Control
- Keywords
- depression, reward, neural, behavior, parent, early childhood
- Medical subject headings
- Depression, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent CoachingBehavioural
Also called PCIT-ED
Three sessions of parent coaching of child positive affect will be administered based on modules from PCIT-ED.
Active ControlBehavioural
General parent support and psychoeducation based on components of standard PCIT.
| Study group | Role | What they receive |
|---|---|---|
| Parent Coaching | Experimental | Parents will receive 3 sessions based on PCIT-ED aimed at increasing child positive affect. Receives: Behavioral: Parent Coaching |
| Active Control | Active comparator | Parents will receive 3 sessions based on traditional PCIT providing more general parenting supporting, including basic psychoeducation and parenting skills. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reward Positivity (RewP)
The Reward Positivity (RewP) ERP component of the EEG signal is the mean amplitude (μV; microvolt) on gain-loss trials during receipt of reward related feedback in a computerized reward task with higher RewP amplitudes indicating greater reward response (i.e., more favorable outcome).
Measured: From baseline week 1 to final assessment week 5 (week 10 maximum)
Secondary outcomes (3)
Parent Responses to Child Positive affect Scale (PRCPS)
Change in total score (sum of 7-point Likert scores) on the mother-reported Parent Responses to Child Positive affect Scale (PRCPS) encouragement subscale. The range of possible scores for this outcome is 0 to 84 with higher scores reflecting higher encouragement (i.e., more favorable outcome).
Measured: From baseline week 1 to final assessment week 5 (week 10 maximum)
Behavioral Coding of Parental Encouragement of Child Positive Emotion
Parent and child positive emotion will be coded separately on a 0 - 2 scale in 5 second increments. Parental encouragement of child positive emotion will be calculated as the proportion of epochs in which mothers display positive emotion subsequent to child positive emotion expression in the previous epoch. Higher scores indicate greater parental encouragement of child positive emotion (i.e., more favorable outcome).
Measured: From baseline week 1 to final assessment week 5 (week 10 maximum)
Late Positive Potential (LPP)
The Late Positive Potential (LPP) ERP component of the EEG signal is the mean amplitude (μV; microvolt) on positive-negative trials during a picture viewing computerized task. Great LPP amplitudes to positive vs. neutral pictures indicate greater response to positive affect (i.e., more favorable outcome).
Measured: From baseline week 1 to final assessment week 5 (week 10 maximum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start28 Oct 2025
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Judith Morgan, University of Pittsburgh
- Investigators
- Judith M Morgan, PhD, Principal investigator, University of PittsburghLauren M. Bylsma, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725160
- Sponsor's protocol ID
- STUDY24040170
- Other IDs
- R01MH135881
- Acronym
- PEACHY
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with the NIH NDA per NIH requirements, which include all primary study measures and demographic information. Participant identifying information is used to create an anonymized GUID to identify participants in the NDA but no identifiable information will be shared publicly.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Positive Affect Socialization and Child Neural Reward Response
- ClinicalTrials.gov ID
- NCT06725160
- Acronym / sponsor ID
- PEACHY / STUDY24040170
- Conditions
- Depression, Parent-Child Relations
- Keywords
- depression, reward, neural, behavior, parent, early childhood
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this mechanistic clinical trial is to examine whether parent-coaching aimed at increasing child positive affect will increase child neural response to reward. The main questions it aims to answer are:
Aim 1. Characterize child neural reward response and its relation to maternal socialization of positive emotions at baseline in healthy young children.
Aim 2. Evaluate how coaching-related changes in maternal socialization of positive emotion expression contribute to increases in child neural reward response over time.
Aim 3. Examine how maternal socialization of positive emotion expression contributes to increases in child neural reward response in the moment.
Participating mother-child dyads will be randomized to either 3 sessions of parent coaching of child positive affect or 3 sessions of a general parenting support intervention and neural response to reward and affective behavior will be examined pre and post intervention.
Detailed description
Reward-related brain function is consistently linked to greater motivation, pleasure, and goal-directed behavior and lower risk for depression across the lifespan. Healthy neural reward response supports socioemotional development, particularly during early childhood as self-regulatory skills and child reward-related brain function are rapidly developing in the context of the caregiving environment. Maternal socialization of positive emotion is one important influence on early reward circuitry development. Mothers with depression are more likely to discourage (and less likely to encourage) child positive emotions compared to healthy mothers, which may contribute to early neural reward alterations in their children. Characterizing mechanisms of influence of maternal socialization on child neural reward response and positive emotion during early childhood is a critical window of opportunity when parents have a large influence on child socioemotional development. Importantly, maternal behavior is amenable to change by training parents on emotion coaching, and these maternal behavior changes may result in direct and immediate changes in child neural reward function. Thus, the overarching aim of this proposal is to use a mechanistic trial design to experimentally test the hypothesis that maternal encouragement of child positive emotion will lead to in-vivo increases in child neural reward response. Event-related potentials (ERPs) are uniquely suited to non-invasively assess in-vivo, fast-occurring changes in child reward response during parent-child interactions, including reward positivity (RewP), and the late positive potential (LPP) amplitudes. Toward this aim, the investigators will randomize 180 mothers with clinically significant depression symptoms and their 4- to 6-year-old children (50% female) to receive either 3 control sessions or 3 positive emotion coaching modules from the Parent-Child Interaction Therapy-Emotion Development (PCIT-ED, which trains mothers on how to encourage positive emotion in their young children. Children will complete reward tasks at pre- and post-coaching, while neural reward response is assessed via ERP (RewP and LPP) with their mothers present allowing for in-vivo assessment of maternal behavior. At both timepoints, the investigators will assess child neural reward response and mothers' self-reported maternal socialization behaviors. Understanding how disrupted neural reward responding develops in early childhood is critical for the promotion of child emotional wellness and can be directly used to develop preventive interventions tailored to young children at familial risk for depression.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Coaching | Experimental | Behavioral: Parent CoachingParents will receive 3 sessions based on PCIT-ED aimed at increasing child positive affect. |
| Active Control | Active comparator | Behavioral: Active ControlParents will receive 3 sessions based on traditional PCIT providing more general parenting supporting, including basic psychoeducation and parenting skills. |
Who may qualify
- Ages
- 4 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Birth mother (biologically female, any gender)
- Providing regular care for participating child (i.e., at least 50% of time)
- Elevated, clinically significant levels of depression (16 or higher on CES-D)
- Aged 18+
- -Aged 4-6 years
Key exclusion criteria (6 listed)
- Lifetime history of a bipolar disorder
- Lifetime history of a psychotic disorder
- T-score greater than 63 on the internalizing or externalizing composites of the CBCL
- Lifetime history of a psychiatric illness
- Lifetime history of neurodevelopmental disorder
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 |
|---|---|---|
| Parent CoachingAlso: PCIT-EDThree sessions of parent coaching of child positive affect will be administered based on modules from PCIT-ED. | Behavioural | Parent Coaching |
| Active ControlGeneral parent support and psychoeducation based on components of standard PCIT. | Behavioural | Active Control |
Primary outcome
Reward Positivity (RewP)
Time frame: From baseline week 1 to final assessment week 5 (week 10 maximum)
The Reward Positivity (RewP) ERP component of the EEG signal is the mean amplitude (μV; microvolt) on gain-loss trials during receipt of reward related feedback in a computerized reward task with higher RewP amplitudes indicating greater reward response (i.e., more favorable outcome).
3 secondary outcomes
Parent Responses to Child Positive affect Scale (PRCPS)
Time frame: From baseline week 1 to final assessment week 5 (week 10 maximum)
Behavioral Coding of Parental Encouragement of Child Positive Emotion
Time frame: From baseline week 1 to final assessment week 5 (week 10 maximum)
Late Positive Potential (LPP)
Time frame: From baseline week 1 to final assessment week 5 (week 10 maximum)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Yes. Data will be shared with the NIH NDA per NIH requirements, which include all primary study measures and demographic information. Participant identifying information is used to create an anonymized GUID to identify participants in the NDA but no identifiable information will be shared publicly.
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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.
Judith M Morgan, PhD principal investigator
University of Pittsburgh
Lauren M. Bylsma, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Coaching in people with Depression and Parent-Child Relations, run by University of Pittsburgh 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Research Coordinator (412-509-8787, PEACHY@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reward Positivity (RewP) (time frame: From baseline week 1 to final assessment week 5 (week 10 maximum)). 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 28 Jan 2026.