Family Promoting Positive Emotions Pilot Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress, Depression, Anhedonia, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorder, Mood Disturbance

Intervention / Treatment
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* Behavioral: Family Promoting Positive Emotions (F-PPE)
* Behavioral: Written Information


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Promoting Positive Emotions Group<br>Each dyad (mother and their child) will receive 8 sessions of promoting positive emotions intervention with a clinician for 8 weeks. | Behavioral: Family Promoting Positive Emotions (F-PPE)<br>* 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.<br>|
| Active Comparator: Written Information Group<br>Mothers will be sent written information and resources on depression for 8 weeks over email. | Behavioral: Written Information<br>* Mothers assigned to the Written Information condition will receive email newsletters providing resources relevant to depression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Anhedonia, Stress, Reward, Mental disorders, Mood disorders