ParentsSSCNCT05048277
Single Session Consultation for Parents
A study testing Single Session Consultation in people with Parents and Stress, run by New York University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Single Session Consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 1 May 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
- Being tested
- Single Session Consultation
- Keywords
- Single Session Consultation, SSC, Parents, Parental Stress, Parenting, Stress, Stress Disorders, Children, School-Aged Children, Parental Mental Health
- Medical subject headings
- Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Session ConsultationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Experimental | 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. Receives: Behavioral: Single Session Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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).
Measured: Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
Strengths and Difficulties Questionnaire (SDQ)
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).
Measured: Screener
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anil Chacko, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048277
- Sponsor's protocol ID
- IRB-FY2021-5325
- Acronym
- SSC
- Status last verified
- Sep 2021
- First submitted
- 24 Aug 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Session Consultation for Parents
- ClinicalTrials.gov ID
- NCT05048277
- Acronym / sponsor ID
- SSC / IRB-FY2021-5325
- Keywords
- Single Session Consultation, SSC, Parents, Parental Stress, Parenting, Stress, Stress Disorders, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 17 Sep 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Experimental | Behavioral: Single Session ConsultationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Single Session ConsultationSingle-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. | Behavioural | Single Arm Study |
Primary outcome
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
Time frame: 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.
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
Time frame: 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).
Change in Family Empowerment Scale (family subscale) from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Time frame: 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.
Change in Readiness for Change Scale from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Time frame: 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.
Change in Beck Hopelessness Scale from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Time frame: 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.
Change in State Hope Scale from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Time frame: 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.
Change in Behavior and Feelings Questionnaire from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Time frame: 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).
Strengths and Difficulties Questionnaire (SDQ)
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Single Session Consultation in people with Parents and Stress, run by New York University.
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 2 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: status not confirmed, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zuania Capo, MA (787-510-1279, zc490@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Screener, Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2021.