Family Promoting Positive Emotions Pilot Study

Vanderbilt University

Status: Completed

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

Treatments: Behavioral: Family Promoting Positive Emotions (F-PPE); Behavioral: Written Information

Study type: Interventional

Funder types: Other

Identifiers

NCT05223842

211324

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

74 participants in 2 patient groups

Family Promoting Positive Emotions Group

Experimental group

Description:

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

Treatment:

Behavioral: Family Promoting Positive Emotions (F-PPE)

Written Information Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Written Information