Family Promoting Positive Emotions Pilot Study
Targeting Positive Emotions to Prevent Emotional Disturbances in Children During COVID-19
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37203
- Vanderbilt University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
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Comparatore attivo: Written Information Group
Mothers will be sent written information and resources on depression for 8 weeks over email.
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Mothers assigned to the Written Information condition will receive email newsletters providing resources relevant to depression.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Child perceived stress
Lasso di tempo: 8 weeks
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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
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Child emotional distress
Lasso di tempo: 8 weeks
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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
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Child positive affect
Lasso di tempo: 8 weeks
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Child reward learning
Lasso di tempo: 8 weeks
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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
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Autumn J Kujawa, PhD, Vanderbilt University
Pubblicazioni e link utili
Collegamenti utili
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 211324
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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Informazioni su farmaci e dispositivi, documenti di studio
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