Project EMPOWERProjectEmpowerNCT05990322
Empowering Economically Insecure Parents to Manage Child Anxiety
A study testing Project EMPOWER in people with Project EMPOWER and Online Resources and Referrals, run by Stony Brook University.
Trial summary
Efforts to develop and disseminate evidence based practices (EBPs) for youth anxiety have made great strides. Still, up to 82.2% of youth who need mental health treatment for anxiety never access care or drop out prematurely; commonly cited barriers to treatment are shortage of care, transportation limitations… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Project EMPOWER, Online Resources and Referrals
- What is being tested?
- Project EMPOWER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Dec 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Have at least one child between the ages of 4-10 years old
- Spouse/partner has not taken part of this study before
- Report clinical levels of child anxiety symptoms, per a score above a 7.5 on the Brief SPENCE Children's Anxiety Scale
- Report economic insecurity, indicated by a score less than or equal to 44 on the Consumer Financial Protection Bureau Financial Well-Being Scale (CFPB)
Who cannot join
- Participant is non-English speaking
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Empowering Anxious Parents to Manage Child Avoidance Behaviors: A Randomized Trial of a Single-Session Intervention Targeting Parent Accommodation
Efforts to develop and disseminate evidence based practices (EBPs) for youth anxiety have made great strides. Still, up to 82.2% of youth who need mental health treatment for anxiety never access care or drop out prematurely; commonly cited barriers to treatment are shortage of care, transportation limitations, financial burden, and gatekeeping behaviors by caretakers. As such, there is great need for accessible, scalable interventions that can ameliorate the global burden of youth anxiety, including those that help prevent the onset of anxiety in high-risk children. Single session interventions (SSIs), which have prevented and reduced child anxiety across numerous trials to date, may offer a promising solution, given their potential disseminability and cost-effectiveness. The proposed randomized trial will evaluate the effects of a novel, web-based, self-guided SSI designed to systematically reduce parent accommodation in economically insecure parents.
Read the detailed description
Anxiety disorders are among the most common, debilitating forms of childhood psychopathology, affecting 8.3-27.0% of youth before the age of 18 (Costello, Egger, \& Angold, 2005). Child anxiety increases risk for psychiatric comorbidities across the lifespan (Copeland, Angold, Shanahan, \& Costello, 2014), creates significant burdens for caregivers (Ramos-Cerqueira et al., 2008), and carries societal costs (Beecham, 2014; Bodden, Dirksen, Bögels, 2008). Although numerous interventions have been developed to treat youth anxiety disorders (Kendall, Achenbrand, \& Hudson, 2003), up to 82.2% of US youth with anxiety will not receive adequate care (Merikangas et al., 2011). Several reasons may explain this discrepancy, including the length and cost of existing evidence-based interventions (EBIs) and limited accessibility for families in need. As such, there is great need for accessible, scalable interventions that can ameliorate the global burden of youth anxiety, including those that help prevent the onset of anxiety in high-risk children.
The inaccessibility of mental health care to low-SES children is especially problematic given the heightened risk for mental health problems within this population. (Bøe et al., 2011; Keating \& Hertzman, 2000; Mendelson et al., 2008). In fact, children and adolescents who are socioeconomically disadvantaged are 3 times more likely to experience mental health difficulties, relative to their more advantaged peers (Reiss, 2013). This may reflect the fact that low SES is closely related to various other risk factors to psychopathology, like weaker family support networks, increased community violence exposure, greater odds of caregivers using harsh discipline strategies, and more exposure to stressful family life events (Everson-Rose et al., 2011; Hill et al., 1996; Shaw et al., 1998; Stein et al., 2003). Access levels vary as well; an examination of nation-wide data of mental health access among adolescents indicate that low-income families are significantly less likely to connect to services (Newacheck et al., 2003). Unfortunately, even when lower-SES youth do access evidence-based treatments, they may benefit less than their more-advantaged peers. It is critical to develop interventions that can not only efficiently target mechanisms most critical to reducing child psychopathology-especially common, impairing problems like anxiety disorders- that are designed for accessibility among historically underserved populations. A simultaneous emphasis on developing and testing child anxiety interventions that are effective and accessible is necessary to adequately serve the lower-SES children and families they are presumably designed to help.
Single-session interventions (SSIs) may offer one potential solution to this gap in care. SSIs include core components of comprehensive EBIs delivered succinctly to improve the odds of access and completion (Schleider \& Weisz, 2017a). In a recent meta-analysis of 50 RCTs, SSIs reduced youth mental health problems of multiple disorders, with SSIs targeting child anxiety producing the largest effects (mean g = 0.58; Schleider \& Weisz, 2017b). Thus, well-targeted SSIs may offer cost-effective additions or alternatives to traditional care for anxiety in youth. Given that family factors play a crucial role in the etiology of child anxiety, SSIs targeting parents and their interactions with offspring offer a novel approach to preventing youth anxiety (Degnan, Almas, Fox, 2010). Thus, the aim of this project is to test the acceptability and short-term effects of a novel, web-based SSI targeting parental accommodation: a well-established, potentially modifiable risk factor for child anxiety. Results may reveal a promising, targeted approach to scalable child anxiety prevention.
Research shows that parent accommodation can be systematically reduced via psychosocial intervention, and interventions targeting accommodation have helped mitigate child anxiety (Lebowitz, 2014). Translating core components of existing interventions that target parental accommodation into briefer, self-administered SSIs (i.e., those that do not involve a trained therapist) may improve families' access to empirically driven supports for child anxiety. It may also enhance the implementation of mental health interventions by lay providers who frequently interact with children (e.g. teachers and pediatricians). Thus, the goal of this project is to test a web-based, self-guided SSI (Project EMPOWER) targeting parental accommodation in a financially diverse sample.
- Conditions
- Project EMPOWER, Online Resources and Referrals
- Being tested
- Project EMPOWER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project EMPOWERBehavioural
Experimental Condition
| Study group | Role | What they receive |
|---|---|---|
| Project EMPOWER | Experimental | Project EMPOWER is a web-based, self-administered SSI for parents that takes about 30 minutes to complete. The program includes 5 elements, based on current best-practices in SSI design (Schleider, Dobias, Sung, \& Mullarkey, 2020) and existing interventions targeting accommodation (Lebowitz \& Omer, 2014): (1) an introduction to the program's rationale; (2) psychoeducation around child anxiety and avoidance, along with how parental accommodation can inadvertently maintain child anxiety; (3) information on how parents can better identify children's patterns of avoidance and encourage brave behavior instead; (4) facilitating parents' creation of an "action plan" for promoting brave behavior and reduce avoidance in their own child; (5) a vignette exercise in which parents read about another family's difficulty managing their child's anxiety; parents identify the elements of the anxiety cycle and provide possible solutions to these parents based on what they learned. Receives: Behavioral: Project EMPOWER |
| Online Resources and Referrals | Placebo comparator | Online Resources and Referrals (ORR) is an information sheet containing materials about the nature of child anxiety and a list of national resources related anxiety treatment. ORR does not include any psychoeducational components regarding parental accommodation. Receives: Behavioral: Project EMPOWER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Accommodation Scale
Family Accommodation Scale is a 9-item measure designed to assess the extent a caregiver accommodate a child's anxiety symptoms; example questions include: "how often did you assist your child in avoiding things that might make him/her more anxious?" and "have you modified your family routine because of your child's symptoms?" Items are rated from 0 (never) to 4 (daily). Scores range from 0-36 with higher scores indicating more frequent parental accommodation
Measured: Change from Baseline to 2-week and 4-week follow up
Perceived pre-to-post SSI change
This two-item measure assesses participants' perceived change in their ability to help their children manage distressing situations and their ability to provide validation to their children from pre- to post-SSI. Parents in both groups will rate this question on a 5-point scale of 1 (much less able) to 5 (much more able).
Measured: Immediately after the SSI
Secondary outcomes (9)
Distress Tolerance Scale
16 item measure assessing the extent to which one experiences and withstand distressing emotional states. Each item is rated on a 5-point Likert scale from 1 (strongly agree) and 5 (strongly disagree). Total score ranges from 16 to 80 with a higher score indicating higher levels of distress tolerance.
Measured: Change from Baseline to 2-week and 4-week follow up
Program Feedback Scale
The program feedback scale asks participants to rate 7 statements regarding acceptability and feasibility; note whether they would recommend this activity to others; and share what they liked and would change about the SSI. The 7 statements are rated from 0 (Really Disagree) to 5 (Really Agree). Total score ranges from 0 to 35, with higher scores indicating a more positive program evaluation.
Measured: Immediately after the SSI
Penn State Worry Questionnaire
16 item self-report questionnaire that asks individuals to rate how typical worry-related problems are for them, from 1 (not at all typical) to 5 (very typical). Scores range from 16-80; higher scores indicate more severe worry.
Measured: Baseline
Consumer Financial Protection Bureau Financial Well-Being Scale
The CFPB Financial Well-Being Scale measures financial well-being as it relates to control over finances, capacity to absorb financial shock, and having the financial freedom to enjoy life. Parents are asked to answer 10 questions on a 0 to 4 Likert scale to generate a sum score, which is converted into a standardized score. Scores range from 14 to 95 with higher scores indicating a higher level of measure financial well-being.
Measured: Baseline
Brief SPENCE Children's Anxiety Scale
8-item measure assessing the severity of child anxiety symptoms on 4 domains: generalized anxiety, separation anxiety, panic/agoraphobia, and social anxiety. Parents are asked to report on how often their child experiences each anxiety symptom on a scale of 0 (never) to 4 (always). Total score ranges from 0 to 32, with higher scores indicating higher levels of anxiety in each domain.
Measured: Change from baseline to 4-week follow-up
Strengths and Difficulties Scale
25-item questionnaire that ask parents to answer questions about their 4 to 17 year old child to screen for 5 domains: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior on a scale of 0 (not true) to 2 (certainly true). Total score ranges from 0 to 40 with higher scores indicating a higher severity of each domain
Measured: Baseline
Parental Stress Scale
18 item measure of parental stress levels, parents rate on a scale of 1 (strongly disagree) to a 5 (strongly agree) scale on their perceived positive and negative experience of being a parent.
Measured: Baseline
Everyday Discrimination Scale
5 item questionnaire used to assess subjective experiences of discrimination. Participants use a scale of 1 (never) to 5 (at least once a week) to rate how often they have experienced discrimination
Measured: Baseline
Patient Health Questionnaire
Patient Health Questionnaire (PHQ-4) is a 4 item scale measuring anxiety and depression. Participants rate each statement on a scale of 0 (not at all) to 4 (nearly every day) to rate the severity of their worry and depression
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Project EMPOWERStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Jessica Schleider, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990322
- Sponsor's protocol ID
- 00195
- Acronym
- ProjectEmpower
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Anxious Parents to Manage Child Avoidance Behaviors: A Randomized Trial of a Single-Session Intervention Targeting Parent Accommodation
- ClinicalTrials.gov ID
- NCT05990322
- Acronym / sponsor ID
- ProjectEmpower / 00195
- Conditions
- Project EMPOWER, Online Resources and Referrals
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 14 Aug 2023 (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.
Efforts to develop and disseminate evidence based practices (EBPs) for youth anxiety have made great strides. Still, up to 82.2% of youth who need mental health treatment for anxiety never access care or drop out prematurely; commonly cited barriers to treatment are shortage of care, transportation limitations, financial burden, and gatekeeping behaviors by caretakers. As such, there is great need for accessible, scalable interventions that can ameliorate the global burden of youth anxiety, including those that help prevent the onset of anxiety in high-risk children. Single session interventions (SSIs), which have prevented and reduced child anxiety across numerous trials to date, may offer a promising solution, given their potential disseminability and cost-effectiveness. The proposed randomized trial will evaluate the effects of a novel, web-based, self-guided SSI designed to systematically reduce parent accommodation in economically insecure parents.
Detailed description
Anxiety disorders are among the most common, debilitating forms of childhood psychopathology, affecting 8.3-27.0% of youth before the age of 18 (Costello, Egger, \& Angold, 2005). Child anxiety increases risk for psychiatric comorbidities across the lifespan (Copeland, Angold, Shanahan, \& Costello, 2014), creates significant burdens for caregivers (Ramos-Cerqueira et al., 2008), and carries societal costs (Beecham, 2014; Bodden, Dirksen, Bögels, 2008). Although numerous interventions have been developed to treat youth anxiety disorders (Kendall, Achenbrand, \& Hudson, 2003), up to 82.2% of US youth with anxiety will not receive adequate care (Merikangas et al., 2011). Several reasons may explain this discrepancy, including the length and cost of existing evidence-based interventions (EBIs) and limited accessibility for families in need. As such, there is great need for accessible, scalable interventions that can ameliorate the global burden of youth anxiety, including those that help prevent the onset of anxiety in high-risk children.
The inaccessibility of mental health care to low-SES children is especially problematic given the heightened risk for mental health problems within this population. (Bøe et al., 2011; Keating \& Hertzman, 2000; Mendelson et al., 2008). In fact, children and adolescents who are socioeconomically disadvantaged are 3 times more likely to experience mental health difficulties, relative to their more advantaged peers (Reiss, 2013). This may reflect the fact that low SES is closely related to various other risk factors to psychopathology, like weaker family support networks, increased community violence exposure, greater odds of caregivers using harsh discipline strategies, and more exposure to stressful family life events (Everson-Rose et al., 2011; Hill et al., 1996; Shaw et al., 1998; Stein et al., 2003). Access levels vary as well; an examination of nation-wide data of mental health access among adolescents indicate that low-income families are significantly less likely to connect to services (Newacheck et al., 2003). Unfortunately, even when lower-SES youth do access evidence-based treatments, they may benefit less than their more-advantaged peers. It is critical to develop interventions that can not only efficiently target mechanisms most critical to reducing child psychopathology-especially common, impairing problems like anxiety disorders- that are designed for accessibility among historically underserved populations. A simultaneous emphasis on developing and testing child anxiety interventions that are effective and accessible is necessary to adequately serve the lower-SES children and families they are presumably designed to help.
Single-session interventions (SSIs) may offer one potential solution to this gap in care. SSIs include core components of comprehensive EBIs delivered succinctly to improve the odds of access and completion (Schleider \& Weisz, 2017a). In a recent meta-analysis of 50 RCTs, SSIs reduced youth mental health problems of multiple disorders, with SSIs targeting child anxiety producing the largest effects (mean g = 0.58; Schleider \& Weisz, 2017b). Thus, well-targeted SSIs may offer cost-effective additions or alternatives to traditional care for anxiety in youth. Given that family factors play a crucial role in the etiology of child anxiety, SSIs targeting parents and their interactions with offspring offer a novel approach to preventing youth anxiety (Degnan, Almas, Fox, 2010). Thus, the aim of this project is to test the acceptability and short-term effects of a novel, web-based SSI targeting parental accommodation: a well-established, potentially modifiable risk factor for child anxiety. Results may reveal a promising, targeted approach to scalable child anxiety prevention.
Research shows that parent accommodation can be systematically reduced via psychosocial intervention, and interventions targeting accommodation have helped mitigate child anxiety (Lebowitz, 2014). Translating core components of existing interventions that target parental accommodation into briefer, self-administered SSIs (i.e., those that do not involve a trained therapist) may improve families' access to empirically driven supports for child anxiety. It may also enhance the implementation of mental health interventions by lay providers who frequently interact with children (e.g. teachers and pediatricians). Thus, the goal of this project is to test a web-based, self-guided SSI (Project EMPOWER) targeting parental accommodation in a financially diverse sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project EMPOWER | Experimental | Behavioral: Project EMPOWERProject EMPOWER is a web-based, self-administered SSI for parents that takes about 30 minutes to complete. The program includes 5 elements, based on current best-practices in SSI design (Schleider, Dobias, Sung, \& Mullarkey, 2020) and existing interventions targeting accommodation (Lebowitz \& Omer, 2014): (1) an introduction to the program's rationale; (2) psychoeducation around child anxiety and avoidance, along with how parental accommodation can inadvertently maintain child anxiety; (3) information on how parents can better identify children's patterns of avoidance and encourage brave behavior instead; (4) facilitating parents' creation of an "action plan" for promoting brave behavior and reduce avoidance in their own child; (5) a vignette exercise in which parents read about another family's difficulty managing their child's anxiety; parents identify the elements of the anxiety cycle and provide possible solutions to these parents based on what they learned. |
| Online Resources and Referrals | Placebo comparator | Behavioral: Project EMPOWEROnline Resources and Referrals (ORR) is an information sheet containing materials about the nature of child anxiety and a list of national resources related anxiety treatment. ORR does not include any psychoeducational components regarding parental accommodation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Have at least one child between the ages of 4-10 years old
- Spouse/partner has not taken part of this study before
- Report clinical levels of child anxiety symptoms, per a score above a 7.5 on the Brief SPENCE Children's Anxiety Scale
- Report economic insecurity, indicated by a score less than or equal to 44 on the Consumer Financial Protection Bureau Financial Well-Being Scale (CFPB)
Key exclusion criteria (1 listed)
- Participant is non-English speaking
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 |
|---|---|---|
| Project EMPOWERExperimental Condition | Behavioural | Online Resources and Referrals, Project EMPOWER |
Primary outcome
Family Accommodation Scale
Time frame: Change from Baseline to 2-week and 4-week follow up
Family Accommodation Scale is a 9-item measure designed to assess the extent a caregiver accommodate a child's anxiety symptoms; example questions include: "how often did you assist your child in avoiding things that might make him/her more anxious?" and "have you modified your family routine because of your child's symptoms?" Items are rated from 0 (never) to 4 (daily). Scores range from 0-36 with higher scores indicating more frequent parental accommodation
Perceived pre-to-post SSI change
Time frame: Immediately after the SSI
This two-item measure assesses participants' perceived change in their ability to help their children manage distressing situations and their ability to provide validation to their children from pre- to post-SSI. Parents in both groups will rate this question on a 5-point scale of 1 (much less able) to 5 (much more able).
9 secondary outcomes
Distress Tolerance Scale
Time frame: Change from Baseline to 2-week and 4-week follow up
Program Feedback Scale
Time frame: Immediately after the SSI
Penn State Worry Questionnaire
Time frame: Baseline
Consumer Financial Protection Bureau Financial Well-Being Scale
Time frame: Baseline
Brief SPENCE Children's Anxiety Scale
Time frame: Change from baseline to 4-week follow-up
Strengths and Difficulties Scale
Time frame: Baseline
Parental Stress Scale
Time frame: Baseline
Everyday Discrimination Scale
Time frame: Baseline
Patient Health Questionnaire
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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 Project EMPOWER in people with Project EMPOWER and Online Resources and Referrals, run by Stony Brook 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 4 inclusion and 1 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 14 Aug 2023. 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. Some participants in this study may receive a placebo. 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 JENNA SUNG, MA (631-632-7800, Jenna.sung@stonybrook.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Accommodation Scale (time frame: Change from Baseline to 2-week and 4-week follow up). The study lists 2 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 14 Aug 2023.