Single Session Consultation for Parents (SSC)
8 septembre 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Anticipé)
40
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Zuania Capo, MA
- Numéro de téléphone: 787-510-1279
- E-mail: zc490@nyu.edu
Sauvegarde des contacts de l'étude
- Nom: Nicole Lui, BS
- Numéro de téléphone: 718-406-3960
- E-mail: nvl221@nyu.edu
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Adult parents (18+ years old) who are legal guardians of their school-age children (5 to 12 years old)
- Must have elevated stress levels based on validated measures obtained through parent self-report
- Parent must reside in the United States
- Must be English dominant
- Can access video-based Zoom conference
Exclusion Criteria:
- Parent has significant cognitive delays that prohibit involvement in SSC
- Parent expresses significant personal mental health challenges/child abuse during SSC that warrant immediate discontinuation from SSC.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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).
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Screener
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 octobre 2021
Achèvement primaire (Anticipé)
1 février 2022
Achèvement de l'étude (Anticipé)
1 mai 2022
Dates d'inscription aux études
Première soumission
24 août 2021
Première soumission répondant aux critères de contrôle qualité
8 septembre 2021
Première publication (Réel)
17 septembre 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 septembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 septembre 2021
Dernière vérification
1 septembre 2021
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IRB-FY2021-5325
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Single Session Consultation
-
University of Massachusetts, WorcesterNational Institute on Minority Health and Health Disparities (NIMHD)Actif, ne recrute pasHypertensionÉtats-Unis