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Prevention of Anhedonia in Children

Primary Purpose

Anhedonia, Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Family Promoting Positive Emotions
Psychoeducation
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anhedonia

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Biological mothers with past or current MDD with anhedonia and their 8- to 12-year-old children English-speaking mothers and children 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 A lifetime manic episode in mothers or children Mothers with current substance use disorders Mothers or children with intellectual or developmental disabilities Mothers or children with vision or hearing impairments that interfere with participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Family Promoting Positive Emotions

    Psychoeducation

    Arm Description

    Outcomes

    Primary Outcome Measures

    Neural responses to rewards measured by electroencephalogram (EEG) in a computerized guessing reward task (physiological measure)
    The reward positivity (RewP) component will be measured using EEG with an established computerized guessing reward task ("Doors" task). EEG data will be processed using best practices and the RewP component will be exported from the EEG data approximately 250-350 ms after feedback presentation at the electrode Cz. RewP scores will be quantified as the relative neural response to reward vs. loss feedback.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 27, 2023
    Last Updated
    August 3, 2023
    Sponsor
    Vanderbilt University
    Collaborators
    Nationwide Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05988138
    Brief Title
    Prevention of Anhedonia in Children
    Official Title
    Reward Responsiveness as a Prevention Target in Youth At Risk for Anhedonia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2025 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt University
    Collaborators
    Nationwide Children's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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, 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anhedonia, Depression

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Family Promoting Positive Emotions
    Arm Type
    Experimental
    Arm Title
    Psychoeducation
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Family Promoting Positive Emotions
    Intervention Description
    An 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mothers
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychoeducation
    Intervention Description
    An 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources
    Primary Outcome Measure Information:
    Title
    Neural responses to rewards measured by electroencephalogram (EEG) in a computerized guessing reward task (physiological measure)
    Description
    The reward positivity (RewP) component will be measured using EEG with an established computerized guessing reward task ("Doors" task). EEG data will be processed using best practices and the RewP component will be exported from the EEG data approximately 250-350 ms after feedback presentation at the electrode Cz. RewP scores will be quantified as the relative neural response to reward vs. loss feedback.
    Time Frame
    4 and 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Biological mothers with past or current MDD with anhedonia and their 8- to 12-year-old children English-speaking mothers and children 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 A lifetime manic episode in mothers or children Mothers with current substance use disorders Mothers or children with intellectual or developmental disabilities Mothers or children with vision or hearing impairments that interfere with participation

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be shared through the National Institute of Mental Health Data Archive

    Learn more about this trial

    Prevention of Anhedonia in Children

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