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Family Promoting Positive Emotions Pilot Study

Primary Purpose

Depression, Anhedonia, Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Promoting Positive Emotions (F-PPE)
Written Information
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Depression, Anhedonia, Stress, Reward, Mental disorders, Mood disorders

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family Promoting Positive Emotions Group

Written Information Group

Arm Description

Each dyad (mother and their child) will receive 8 sessions of promoting positive emotions intervention with a clinician for 8 weeks.

Mothers will be sent written information and resources on depression for 8 weeks over email.

Outcomes

Primary Outcome Measures

Child perceived stress
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.
Child emotional distress
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.
Child positive affect
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 Outcome Measures

Child reward learning
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.

Full Information

First Posted
October 4, 2021
Last Updated
January 31, 2023
Sponsor
Vanderbilt University
Collaborators
American Psychological Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05223842
Brief Title
Family Promoting Positive Emotions Pilot Study
Official Title
Targeting Positive Emotions to Prevent Emotional Disturbances in Children During COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
American Psychological Foundation

4. Oversight

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

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anhedonia, Stress, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorder, Mood Disturbance
Keywords
Depression, Anhedonia, Stress, Reward, Mental disorders, Mood disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Promoting Positive Emotions Group
Arm Type
Experimental
Arm Description
Each dyad (mother and their child) will receive 8 sessions of promoting positive emotions intervention with a clinician for 8 weeks.
Arm Title
Written Information Group
Arm Type
Active Comparator
Arm Description
Mothers will be sent written information and resources on depression for 8 weeks over email.
Intervention Type
Behavioral
Intervention Name(s)
Family Promoting Positive Emotions (F-PPE)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Written Information
Intervention Description
Mothers assigned to the Written Information condition will receive email newsletters providing resources relevant to depression.
Primary Outcome Measure Information:
Title
Child perceived stress
Description
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.
Time Frame
8 weeks
Title
Child emotional distress
Description
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.
Time Frame
8 weeks
Title
Child positive affect
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Child reward learning
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Autumn J Kujawa, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be available for sharing by request.
IPD Sharing Time Frame
Immediately after publication.
IPD Sharing Access Criteria
Principal investigator will review requests and grant access depending on the research question/plan and overlap with ongoing analyses in the laboratory.
Links:
URL
https://my.vanderbilt.edu/medlab/
Description
Laboratory website

Learn more about this trial

Family Promoting Positive Emotions Pilot Study

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