[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06725160":3,"trial-entities:NCT06725160":117,"trial-summary:NCT06725160":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":47,"secondary_outcomes":52,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":81,"locations":85,"central_contacts":104,"overall_officials":109,"references":115,"see_also_links":116},"NCT06725160","STUDY24040170","Parent Encouragement And Coaching of Happiness in Youth","Maternal Positive Affect Socialization and Child Neural Reward Response","RECRUITING","2029-02-01","2026-01","2026-01-28","2025-10-28","University of Pittsburgh","OTHER",false,"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:\n\nAim 1. Characterize child neural reward response and its relation to maternal socialization of positive emotions at baseline in healthy young children.\n\nAim 2. Evaluate how coaching-related changes in maternal socialization of positive emotion expression contribute to increases in child neural reward response over time.\n\nAim 3. Examine how maternal socialization of positive emotion expression contributes to increases in child neural reward response in the moment.\n\nParticipating 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.","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.",[19,20],"Depression","Parent-Child Relations",[22,23,24,25,26,27],"depression","reward","neural","behavior","parent","early childhood","INTERVENTIONAL","BASIC_SCIENCE",[31],"NA",{"count":33,"type":34},180,"ESTIMATED",[36,43],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"BEHAVIORAL","Parent Coaching","Three sessions of parent coaching of child positive affect will be administered based on modules from PCIT-ED.",[38],[42],"PCIT-ED",{"type":37,"name":44,"description":45,"armGroupLabels":46},"Active Control","General parent support and psychoeducation based on components of standard PCIT.",[44],[48],{"measure":49,"description":50,"timeFrame":51},"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).","From baseline week 1 to final assessment week 5 (week 10 maximum)",[53,56,59],{"measure":54,"description":55,"timeFrame":51},"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).",{"measure":57,"description":58,"timeFrame":51},"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).",{"measure":60,"description":61,"timeFrame":51},"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).","ALL","4 Years","99 Years",true,{"inclusion":67,"exclusion":73,"raw_text":80},[68,69,70,71,72],"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",[74,75,76,77,78,79],"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","Inclusion Criteria for Mothers:\n\n* Birth mother (biologically female, any gender)\n* Providing regular care for participating child (i.e., at least 50% of time)\n* Elevated, clinically significant levels of depression (16 or higher on CES-D)\n* Aged 18+\n\nExclusion Criteria for Mothers:\n\n* Lifetime history of a bipolar disorder\n* Lifetime history of a psychotic disorder\n\nInclusion Criteria for Participating Child:\n\n-Aged 4-6 years\n\nExclusion Criteria for Participating Child:\n\n* T-score greater than 63 on the internalizing or externalizing composites of the CBCL\n* Lifetime history of a psychiatric illness\n* Lifetime history of neurodevelopmental disorder\n* Lifetime history of neurological disorder",[82,83,84],"CHILD","ADULT","OLDER_ADULT",[86],{"facility":13,"status":8,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":101},"Pittsburgh","Pennsylvania","15213","United States",[92,97],{"name":93,"role":94,"phone":95,"email":96},"Lauren M Bylsma, PhD","CONTACT","412-624-8363","BylsmaL@pitt.edu",{"name":98,"role":94,"phone":99,"email":100},"Judith K Morgan, PhD","412-383-5454","jkm46@pitt.edu",{"lat":102,"lon":103},40.44062,-79.99589,[105],{"name":106,"role":94,"phone":107,"email":108},"Julie Research Coordinator","412-509-8787","PEACHY@upmc.edu",[110,113],{"name":111,"affiliation":13,"role":112},"Judith M Morgan, PhD","PRINCIPAL_INVESTIGATOR",{"name":114,"affiliation":13,"role":112},"Lauren M. Bylsma, PhD",[],[],{"nct_id":4,"conditions":118,"biomarkers":119},[19],[],{"nct_id":4,"found":65,"summary":121,"prompt_version":131},{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This is an interventional study with a planned enrollment of 180 participants. It compares two behavioral interventions: Parent Coaching and Active Control.","completed","Parent Coaching for Happiness in Youth with Maternal Depression","This study, called \"Parent Encouragement And Coaching of Happiness in Youth,\" is looking at how parent coaching can help children's brain responses to rewards, especially when mothers experience depression. It involves mothers aged 18 and older who have elevated depression levels and are the primary caregivers for children aged 4 to 99. Participants will either receive \"Parent Coaching\" focused on increasing positive emotions in their child, or \"Active Control\" which provides general parent support. The main goal is to see if this coaching can improve a child's \"Reward Positivity\" (RewP), which is a measure of how their brain responds to positive experiences, over a period of up to 10 weeks. This study aims to understand how mothers' interactions can influence their child's emotional development.","The primary endpoint, Reward Positivity (RewP), is measured from baseline week 1 to the final assessment at week 5 (maximum week 10).",124,"Not specified in the trial record.","Not stated in the trial record.",[38,44],"v2"]