- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT05223842
Family Promoting Positive Emotions Pilot Study
Targeting Positive Emotions to Prevent Emotional Disturbances in Children During COVID-19
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Tennessee
-
Nashville, Tennessee, Verenigde Staten, 37203
- Vanderbilt University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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.
|
Actieve vergelijker: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Child perceived stress
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Child reward learning
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Autumn J Kujawa, PhD, Vanderbilt University
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Ziekten van het zenuwstelsel
- Neurologische manifestaties
- Neurologische gedragsmanifestaties
- Schizofreniespectrum en andere psychotische stoornissen
- Depressie
- Depressieve stoornis
- Ziekte
- Psychotische stoornissen
- Anhedonie
- Psychische aandoening
- Stemmingsstoornissen
- Gedragssymptomen
Andere studie-ID-nummers
- 211324
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .