Family Promoting Positive Emotions Pilot Study

NCT05223842 | Completed

• 1 other identifier: 211324
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Depression; Anhedonia; Stress; Reward; Mental disorders; Mood disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Child reward learning

  8 weeks

Study Arms (2)

Family Promoting Positive Emotions Group

EXPERIMENTAL

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)

Written Information Group

ACTIVE COMPARATOR

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

Behavioral: Written Information

Interventions

Family Promoting Positive Emotions (F-PPE) 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.

Family Promoting Positive Emotions Group

Written Information BEHAVIORAL

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

Written Information Group

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• American Psychological Foundation: collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• 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.

  PMID: 37591042 DERIVED

Related Links

• Laboratory website

MeSH Terms

Conditions

Depression; Anhedonia; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Autumn J Kujawa, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology and Human Development

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: February 4, 2022
• Study Start: December 1, 2021
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Immediately after publication.
• Access Criteria: Principal investigator will review requests and grant access depending on the research question/plan and overlap with ongoing analyses in the laboratory.

Locations

US (1)