Family Promoting Positive Emotions Pilot Study

Not Applicable

Completed

• Conditions: Depression; Mood Disorders; Stress; Depressive Disorder; Behavioral Symptoms; Anhedonia; Mental Disorder; Mood Disturbance
• Interventions: Behavioral: Family Promoting Positive Emotions (F-PPE); Behavioral: Written Information

• Registration Number: NCT05223842
• Lead Sponsor: Vanderbilt University

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.

Study Timeline

• Study First Submitted: 2021-10-04
• Study Start: 2021-12-01
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-02-04
• Status Verified: 2023-01
• Primary Completion: 2023-01-20
• Study Completion: 2023-01-20
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family Promoting Positive Emotions Group	Family Promoting Positive Emotions (F-PPE)	Each dyad (mother and their child) will receive 8 sessions of promoting positive emotions intervention with a clinician for 8 weeks.
Written Information Group	Written Information	Mothers will be sent written information and resources on depression for 8 weeks over email.

Primary Outcome Measures

Name	Time	Method
Child emotional distress	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.
Child positive affect	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.
Child perceived stress	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.

Secondary Outcome Measures

Name	Time	Method
Child reward learning	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.

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States