Family Promoting Positive Emotions Pilot Study

NCT ID: NCT05223842

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-01-20

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Family Promoting Positive Emotions Group

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

Group Type EXPERIMENTAL

Family Promoting Positive Emotions (F-PPE)

Intervention Type BEHAVIORAL

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 Group

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

Group Type ACTIVE_COMPARATOR

Written Information

Intervention Type BEHAVIORAL

Mothers assigned to the Written Information condition will receive email newsletters providing resources relevant to depression.

Interventions

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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.

Intervention Type BEHAVIORAL

Written Information

Mothers assigned to the Written Information condition will receive email newsletters providing resources relevant to depression.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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

* 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.


* 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.
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Psychological Foundation

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Autumn Kujawa

Assistant Professor of Psychology and Human Development

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Autumn J Kujawa, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Burkhouse KL, Dao A, Argiros A, Granros M, Cardenas E, Dickey L, Feurer C, Hill K, Pegg S, Venanzi L, Kujawa A. Targeting positive valence systems function in children of mothers with depressive symptoms: A pilot randomized trial of an RDoC-Informed preventive intervention. Behav Res Ther. 2023 Sep;168:104384. doi: 10.1016/j.brat.2023.104384. Epub 2023 Aug 9.

Reference Type DERIVED
PMID: 37591042 (View on PubMed)

Related Links

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Other Identifiers

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211324

Identifier Type: -

Identifier Source: org_study_id

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