DepressionNCT05223842
Family Promoting Positive Emotions Pilot Study
A study testing Family Promoting Positive Emotions (F-PPE) and Written Information in people with Depression and Anhedonia, run by Vanderbilt University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Depression, Anhedonia, Stress
- What is being tested?
- Family Promoting Positive Emotions (F-PPE) and Written Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Targeting Positive Emotions to Prevent Emotional Disturbances in Children During COVID-19
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.
Read the 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.
- Conditions
- Depression, Anhedonia, Stress, Depressive Disorder, Behavioral Symptoms, Mood Disorders
- Being tested
- Family Promoting Positive Emotions (F-PPE), Written Information
- Keywords
- Depression, Anhedonia, Stress, Reward, Mental disorders, Mood disorders
- Medical subject headings
- Depression, Anhedonia, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Promoting Positive Emotions (F-PPE)Behavioural
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 InformationBehavioural
Mothers assigned to the Written Information condition will receive email newsletters providing resources relevant to depression.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Written Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (1)
Child reward learning
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Dec 2021
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Foundation
- Responsible party
- Principal investigator, Autumn Kujawa, Vanderbilt University
- Investigators
- Autumn J Kujawa, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223842
- Sponsor's protocol ID
- 211324
- Status last verified
- Jan 2023
- First submitted
- 4 Oct 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be available for sharing by request.
Publications
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.
PubMed 37591042
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Positive Emotions to Prevent Emotional Disturbances in Children During COVID-19
- ClinicalTrials.gov ID
- NCT05223842
- Acronym / sponsor ID
- 211324
- Conditions
- Depression, Anhedonia, Stress, Depressive Disorder, Behavioral Symptoms, Mood Disorders
- Keywords
- Depression, Anhedonia, Stress, Reward, Mental disorders, Mood disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- American Psychological Foundation
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Promoting Positive Emotions Group | Experimental | Behavioral: Family Promoting Positive Emotions (F-PPE)Each dyad (mother and their child) will receive 8 sessions of promoting positive emotions intervention with a clinician for 8 weeks. |
| Written Information Group | Active comparator | Behavioral: Written InformationMothers will be sent written information and resources on depression for 8 weeks over email. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Family Promoting Positive Emotions Group |
| Written InformationMothers assigned to the Written Information condition will receive email newsletters providing resources relevant to depression. | Behavioural | Written Information Group |
Primary outcome
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.
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.
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.
1 secondary outcome
Child reward learning
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Derived from this study: PubMed 37591042Burkhouse 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.
- Laboratory websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified data will be available for sharing by request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Autumn J Kujawa, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Promoting Positive Emotions (F-PPE) and Written Information in people with Depression and Anhedonia, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child perceived stress (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05223842, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.