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Single Session Consultation for Parents (SSC)

2021. szeptember 8. frissítette: Dr. Anil Chacko, New York University

Single-Session Consultation (SSC) is a rapidly provided, low-intensity, goal-directed counseling service used for treatment of diverse mental health problems. Research on SSC suggests that, for some clients, a single session of counseling (60 minutes) may help reduce clinical distress.

Despite its benefits, SSC has yet to be evaluated as an alternative for parents (18+) of school-age children (5-12 years old) in the United States with elevated stress levels.

The current research aims to evaluate SSC's feasibility, acceptability, and efficacy as an intervention for this population.

First, perceived acceptability (i.e., parents' participation and successful completion, reschedules, and/or cancellations), usefulness, and client satisfaction will be examined. The investigators will also evaluate whether mechanisms of change (e.g, hope, agency), parental (e.g, stress, mental health), and child (e.g, behavior) outcomes, are improved following the SSC.

The investigators expect SSC to be acceptable, for clients to find SSC to be useful, to be satisfied, and experience an increase in hope and agency after the SSC and hypothesize a reduction in stress levels and improvement in mental health among parents. However, the investigators believe behavior outcomes for the child will remain unchanged.

The investigators will recruit parents via online advertisement on social media. Potential participants will complete a screener through Qualtrics to determine eligibility, which includes location in the United States, age (18+), child's age (5-12 years old), preferred language, child's legal guardianship, technology access, and stress levels. Once eligible, participants will provide consent and make an appointment for their SSC.

The 60-minutes-session will be conducted using HIPAA complaint NYU Zoom with Study Consultants. Parents will complete assessments of parental stress, parental mental health, and child behavior to assess mechanisms (i.e., hope, agency) outcomes and measures of usefulness and satisfaction prior and post the SSC, and another 2-week follow-up questionnaire to monitor progress.

Sessions will be recorded for supervision and treatment fidelity purposes. Upon completion, parents will receive an Action Plan, a written record of the discussion, recommendations, and resources.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Várható)

40

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

  • Név: Zuania Capo, MA
  • Telefonszám: 787-510-1279
  • E-mail: zc490@nyu.edu

Tanulmányozza a kapcsolattartók biztonsági mentését

  • Név: Nicole Lui, BS
  • Telefonszám: 718-406-3960
  • E-mail: nvl221@nyu.edu

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Összes

Leírás

Inclusion Criteria:

  1. Adult parents (18+ years old) who are legal guardians of their school-age children (5 to 12 years old)
  2. Must have elevated stress levels based on validated measures obtained through parent self-report
  3. Parent must reside in the United States
  4. Must be English dominant
  5. Can access video-based Zoom conference

Exclusion Criteria:

  1. Parent has significant cognitive delays that prohibit involvement in SSC
  2. Parent expresses significant personal mental health challenges/child abuse during SSC that warrant immediate discontinuation from SSC.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: N/A
  • Beavatkozó modell: Egyetlen csoportos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Single Arm Study
The intervention will consist of one 60-minute long session conducted through NYU ZOOM. Each session will be between one parent and one study consultant. The session is goal-oriented and solution-focused. During the SSC, consultants will identify the participant's hope for the session and a specific modifiable goal. From this, the consultant will discuss the "smallest-possible step" participants can take toward overcoming their identified problem and work together in creating an Action Plan, which will present three specific actions the participant can take to accomplishing the session's established goals. Following completion of the two-week follow-up assessment, additional resources personalized to participants will also be provided (i.e., referrals for further services and online resources for parents/children). Ultimately, this intervention is a way to potentially jumpstart progress and facilitate hope and agency.
Viselkedési: Single Session Consultation
Single-Session Consultation (SSC) is a low-intensity, goal-directed, solution-focused counseling service used for treatment of mental health problems. The intervention consists of a 60-minute session conducted through NYU ZOOM, a HIPAA compliant teleconferencing platform. Sessions will be conducted between a parent and a study consultant. The consultant will 1) identify the participant's specific modifiable goal (and associated "hope"); 2) the "smallest-possible step" taken to overcome their problem; and 3) work collaboratively in creating an Action Plan, drawing on their inner abilities and external resources. This intervention does not act as therapy but instead, to potentially jumpstart progress and facilitate hope and agency. Following completion, participants will receive their Action Plan. Additional personalized resources will be provided following completion of the follow-up assessment, which includes referrals for further services and online resources.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change in Parenting Stress [Fragile Families Aggravation in Parenting Scale (FFAPS)] from Screener to Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Időkeret: Screener, Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
The Fragile Families Aggravation in Parenting Scale is a four-item scale completed by parents to assess parenting stress. Items are rated on a scale from strongly agree to strongly disagree, with greater agreement of items relating to higher levels of stress. The FFAPS has been used in longitudinal studies of parenting and family functioning in the United States and is psychometrically validated for parents of preschool-school-age children. This measure will be used to screen for participant eligibility and as an outcome measure.
Screener, Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
Change in Positive and Negative Affect Schedule Short Form (PANAS-SF) from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Időkeret: Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
The PANAS -SF is a 10-item self-report measure that assesses positive affect and negative affect in adults. Scores range from 1 (very slightly or not at all) to 5 (extremely). The items correlate with more specific measures of adult mood and anxiety and is often used in research with community samples to assess mental health functioning. The PANAS-SF is psychometrically-validated (Thomas et al., 2007).
Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
Change in Family Empowerment Scale (family subscale) from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Időkeret: Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
The Family Empowerment Scale (FES) is a parent-report measure to specifically assess empowerment in families with children with emotional/behavioral challenges. The "About Your Family" subscale is a six-item subscale that focuses on parents' confidence in managing their family/child. Scores range from 1 (never) to 5 (very often). Higher total scores indicate a higher level of parent empowerment. The FES has been used in intervention studies with parents/families and has strong psychometric properties.
Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
Change in Readiness for Change Scale from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Időkeret: Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
The Readiness for Change Ruler is a three-item parent-report of parents motivation for change. The ruler is based on the motivational interviewing literature and has been adapted for use for a specific population and research questions. Scores range from 0 (not at all confident/important/ready) to 10 (completely confident/important/ready), with scores above a 5 showing that the person is willing to consider change. The ruler was adapted for use with parents who have stress related to parenting.
Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
Change in Beck Hopelessness Scale from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Időkeret: Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
The Beck Hopelessness Scale is a four-item self-report measure assessing adult hopelessness about the future. Scores range from 1 (absolutely disagree) to 4 (absolutely agree), with higher total scores equating to greater levels of hopelessness. The Beck Hopelessness scale is psychometrically valid.
Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
Change in State Hope Scale from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Időkeret: Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
The State Hope Scale offers a brief, internally consistent, and valid self-report measure of ongoing goal-directed thinking of adults. Scores range from 1 (definitely false) to 8 (definitely true), with higher total scores equating to greater levels of agency.
Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
Change in Behavior and Feelings Questionnaire from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Időkeret: Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
The Behavior and Feelings Survey (BFS) is a brief, 12-item rating scale designed to facilitate efficient progress-monitoring during youth psychotherapy. It was developed and evaluated in four samples, among youths ages 7-15 years, with results demonstrating a robust factor structure, internal consistency, test-retest reliability, convergent and discriminant validity, and utility for tracking change during youth psychotherapy (Weisz et al., 2019). The BFS offers caregiver-report forms. Items are rated on a scale from 0 (not a problem) to 4 (a very big problem). Three scale scores can be derived: Internalizing Problems (sum of items 1-6), Externalizing Problems (sum of items 7-12), and Total Problems (sum of items 1-12).
Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
Strengths and Difficulties Questionnaire (SDQ)
Időkeret: Screener
The Strengths and Difficulties Questionnaire (SDQ) is a short behavioral screening questionnaire for children aged 3 to 16. The questionnaire is used to assess children's mental health and can be completed by children and young people themselves, by their parents, or by their teachers. Scores range between not true to somewhat true to certainly true. For this study, parents will complete the 25 attributes/questions from the SDQ. These 25 items are divided between 5 scales: emotional symptoms (5 items), conduct problems (5 items), hyperactivity/inattention (5 items), peer relationship problems (5 items), prosocial behavior (5 items).
Screener

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

New York University

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Várható)

2021. október 1.

Elsődleges befejezés (Várható)

2022. február 1.

A tanulmány befejezése (Várható)

2022. május 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2021. augusztus 24.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2021. szeptember 8.

Első közzététel (Tényleges)

2021. szeptember 17.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2021. szeptember 17.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2021. szeptember 8.

Utolsó ellenőrzés

2021. szeptember 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

Egyéb vizsgálati azonosító számok

  • IRB-FY2021-5325

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

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Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

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Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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