- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05223842
Family Promoting Positive Emotions Pilot Study
Targeting Positive Emotions to Prevent Emotional Disturbances in Children During COVID-19
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Vanderbilt University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Active Comparator: Written Information Group
Mothers will be sent written information and resources on depression for 8 weeks over email.
|
Mothers assigned to the Written Information condition will receive email newsletters providing resources relevant to depression.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child perceived stress
Time Frame: 8 weeks
|
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
Time Frame: 8 weeks
|
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
Time Frame: 8 weeks
|
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
Time Frame: 8 weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Autumn J Kujawa, PhD, Vanderbilt University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 211324
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Behavioral Symptoms
-
AccareRecruitingBehavioral Problem of Child | Behavioral DifficultiesNetherlands
-
University of AarhusInnovation Fund Denmark; TRYG Foundation; The Danish Mental Health Foundation; Aarhus...CompletedDepressive Symptoms | Anxiety Symptoms | Behavioral Problem | School AbsenteeismDenmark
-
Universidade do PortoCentro Hospitalar Universitário de São João, E.P.E.; Centro de Investigação... and other collaboratorsCompletedAnxiety | Behavioral Problem of ChildPortugal
-
Central Hospital, Nancy, FranceMarie MANGEOT- Nurse; Mahmut GUNDESLI MDCompleted
-
AccareRecruitingBrief Parent Training for Children With Behavioral Difficulties in Primary Care Settings (PAINT-POH)Behavioral DifficultiesNetherlands
-
Fatima Jinnah Women UniversityRecruitingWell-being, Emotional and Behavioral Problems, AdolescentsPakistan
-
National Taiwan University HospitalMinistry of Science and Technology, TaiwanCompleted
-
AccareRecruitingBehavioral Symptoms | Behavior Problems | Behavioral Problems | Disruptive Behavior | Problem Behaviors | Behavioral DifficultiesNetherlands
-
University of California, San FranciscoCompleted
-
New York State Psychiatric InstituteSackler FoundationTerminated
Clinical Trials on Family Promoting Positive Emotions (F-PPE)
-
Vanderbilt UniversityNationwide Children's HospitalRecruiting
-
University of Notre DameRecruitingAdolescent | Parent-Child Relations | Violence | PsychopathologyUnited States