Family Promoting Positive Emotions Pilot Study

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05223842
• Other study ID #: 211324
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: January 20, 2023

Study information

• Verified date: January 2023
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anhedonia
• Behavioral Symptoms
• Depression
• Depressive Disorder
• Disease
• Mental Disorder
• Mental Disorders
• Mood Disorders
• Mood Disturbance
• Psychotic Disorders
• Stress

Intervention

Behavioral:
• Family Promoting Positive Emotions (F-PPE)
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
Mothers assigned to the Written Information condition will receive email newsletters providing resources relevant to depression.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	American Psychological Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Primary	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.	8 weeks
Primary	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.	8 weeks
Secondary	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.	8 weeks

External Links

•   Laboratory website