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Completed

NCT Number: NCT05223842

Family Promoting Positive Emotions Pilot Study

Anhedonia is characterized by loss of interest or pleasure. The proposed pilot study would be the first to test an innovative, neuroscience-informed intervention in mothers reporting depressive symptoms and stress to enhance positive emotionality with the goal of preventing anhedonia and associated emotional disturbances in their children. This study will recruit dyads (mothers and their children) for the intervention.

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Key information

Conditions

Depression Anhedonia Behavior Behavioral Symptoms Depressive Disorder Mental Disorder Mental Disorders Mood Disorders Mood Disturbance Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University

Nashville, Tennessee, 37203, United States

About this study

Anhedonia, characterized by loss of interest or pleasure, is a primary symptom of depression. Depression is increasingly prevalent and can cause significant impairments in life functioning. Given the increased presence of stress during COVID-19, there is a significant need for interventions that can prevent the development of anhedonia and depression. This study examines a neuroscience-informed positive emotion intervention to determine its effects on preventing anhedonia and associated emotional disturbances in dyads of children and their mothers. Participants will be randomized to either receive the positive emotion intervention for 8 sessions for 8 weeks with a clinician or the self-administered written information condition. Depressive symptoms, anhedonia, stress and other internalizing disorders will be assessed at baseline, and at the end of the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for mothers:

  • Age 18 and older who report at least subthreshold current depressive symptoms (> score of 8 on the Patient Health Questionnaire) and moderate COVID-19-related stress
  • Can read and speak in English.
  • Have access to a computer with a videoconferencing platform.

Inclusion criteria

for children:

  • Age 8-12 years who can participate with their biological mother who is 18 years or older that meets the above criteria.
  • Can read and speak in English.

Exclusion criteria

for mothers:

  • Current substance use disorder.
  • Intellectual disabilities.
  • Diagnosis of mania or bipolar disorder.
  • Diagnosis of a psychotic disorder (e.g., schizophrenia).
  • Visual or hearing impairments that interfere with completing study measures and sessions.

Exclusion criteria

for children:

  • Diagnoses of autism spectrum disorders or developmental disorders.
  • Intellectual disabilities.
  • Diagnosis of mania or bipolar disorder.
  • Diagnosis of a psychotic disorder (e.g., schizophrenia).
  • Currently experiencing depressive symptoms.
  • Visual or hearing impairments that interfere with completing study measures and sessions.
  • Offspring of mothers who have previously participated in the study with another biological child.

Treatment and study plan

Family Promoting Positive Emotions (F-PPE)

Behavioral

F-PPE is an 8-session dyadic intervention designed to enhance positive emotionality and buffer against the effects of stress on anhedonia in children. The intervention will be administered online through videoconferencing sessions with a clinician to mothers and their children.

Written Information

Behavioral

Mothers assigned to the Written Information condition will receive email newsletters providing resources relevant to depression.

Primary outcomes

  1. Child perceived stress

    Time frame: 8 weeks

    The National Institutes of Health Toolbox Perceived Stress survey consists of 10 questions with options ranging in value from 1 to 5 to assess self-reported perceived stress for children (self- and parent-report). The minimum score is 10 and the maximum score is 50, with higher values meaning greater stress.

    Hypothesis 1a: Children in the F-PPE group will show lower post-intervention perceived stress compared to the written information group.

  2. Child emotional distress

    Time frame: 8 weeks

    The Patient-Reported Outcomes Measurement Information System (Anxiety, Depression, Anger) short form consists of questions with five response options ranging in value from 1 to 5 to assess self-reported anxiety, depression, anger and irritability for participants (parent, child, and parent report). Total scores on the emotional distress scales for children range from 33 to 165 for self-report and 26 to 130 for parent report, with higher scores reflect greater distress.

    Hypothesis 1b: Children in the F-PPE group will show lower post-intervention emotional distress compared to the written information group.

  3. Child positive affect

    Time frame: 8 weeks

    Positive affect will be assessed using the positive affect scale of the Positive and Negative Affect Schedule for Children administered through ecological momentary assessment over 10 days. Children rate their current affect on 5 items with a 1 to 5 scale for total scores from 5 to 25, with greater values reflecting greater positive affect.

    Hypothesis 2a: Children in the F-PPE group will show relative increases in daily positive affect from pre- to post-intervention compared to the written information condition.

    Hypothesis 2b: Changes in positive affect will partly account for F- PPE effects on child perceived stress and emotional distress.

    Hypothesis 2c: Changes in positive affect will partly account for F- PPE effects on child perceived stress and emotional distress.

Secondary outcomes

  1. Child reward learning

    Time frame: 8 weeks

    Reward learning will be measured using a Reinforcement Learning Task. The extent to which children begin to preferentially select the button that is more likely to be reinforced as a reward across the task will be used to quantify reinforcement learning.

    Hypothesis 3a: Children in the F-PPE group will show relative increases in reward learning from pre- to post-intervention compared to the written information condition.

    Hypothesis 3b: Changes in reward learning will partly account for F- PPE effects on child perceived stress and emotional distress.

    Hypothesis 3c: Changes in reward learning will partly account for F- PPE effects on child perceived stress and emotional distress.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • American Psychological Foundation

Registry information

Official study title

Targeting Positive Emotions to Prevent Emotional Disturbances in Children During COVID-19

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 4, 2022
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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