Clinical trial NCT05223842: Family Promoting Positive Emotions Pilot Study
Official title: Targeting Positive Emotions to Prevent Emotional Disturbances in Children During COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anhedonia
Stress
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorder
Mood Disturbance
Keywords: Depression
Anhedonia
Stress
Reward
Mental disorders
Mood disorders
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: American Psychological Foundation
First posted: 2022-02-04
Enrollment: 74
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Child perceived stress
timeFrame: 8 weeks
measure: Child emotional distress
timeFrame: 8 weeks
measure: Child positive affect
timeFrame: 8 weeks
Secondary outcomes:
measure: Child reward learning
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Autumn J Kujawa, PhD
role: PRINCIPAL_INVESTIGATOR
References: