Anxiety DisordersNCT07153250
Online Parent Education for Child Anxiety
A study testing Project EMPOWER, Being Brave Parent Education and Sharing Feelings in people with Anxiety Disorders, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators are doing this research to test whether parents of children ages 2-7 can better manage their child's anxiety by completing a brief, online, self-guided parent education program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Project EMPOWER, Being Brave Parent Education and Sharing Feelings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parents will be eligible to participate if:
- Their child is between the age of 2 and 7 years-old
- Their child scores in the elevated range on an age-approrpiate anxiety screening measure
- Parents are English-speaking
- Parents are over the age of 18 years old
Who cannot join
- Parents will be excluded if:
- Their child shows symptoms of suicidal or homicidal ideation, psychosis, or primary severe mood or behavior disorder (i.e., if treatment for another disorder other than anxiety is indicate prior to treatment for anxiety)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Evaluating the Effects of Self-Guided Interventions for Parents of Young Children With Anxiety
The investigators are doing this research to test whether parents of children ages 2-7 can better manage their child's anxiety by completing a brief, online, self-guided parent education program. One way to provide anxiety management skills to more children, and to potentially prevent worsening outcomes, is to offer online and self-guided educational programs that parents can complete without a clinician. This randomized trial will evaluate the effects of two brief, online, self-guided parent education programs designed to improve parents' understanding of anxiety and teach parents way to help their children cope with anxiety. Parents will be randomly assigned to one of the three programs. The main aim of the study is to examine whether the parent programs, compared to an educational control reduce parental accommodation of anxiety across a 1-, 4-, and 8-month follow-up period. As a secondary aim, the investigators will explore whether the parent programs reduce children's anxiety symptoms over the 8-month follow-up period. Results will inform the development of a scalable, low-cost model for promoting access to evidence-based treatment to young children.
Read the detailed description
Anxiety disorders are very common in children, affecting as many as 30% by adolescence. Even 10% of preschool-age children are already affected. These disorders cause distress and can interfere with academic, social, and family functioning. There are very effective treatments for anxiety disorders, but, on average, kids suffer for four years between onset of their anxiety symptoms and proper diagnosis and treatment. Young children often do not receive treatment because pediatricians, parents, and teachers do not realize that treatment can benefit them and because there is a shortage of providers trained to provide mental health care to young children. Given the importance of early intervention, the investigators are interested in whether parents can learn to better manage their child's anxiety by completing a brief, online, and self-guided parent education program.
Parents will be randomized to one of three self-guided education programs: A three-session program with videos and a workbook and two single-session programs with activities. The programs teach parents how to promote brave behaviors in their child (rather than allowing the child to avoid situations that make them nervous). One of the three programs is considered a control condition, but all are education, and parents will not know whether they are in the control condition until after the 4-month evaluation when they will have the chance to be reassigned to one of the other conditions. The investigators predict that parents who receive one of the active programs, compared to the control, will report greater reductions in parental accommodation across 1-, 4-, and 8-month follow-up. As a secondary hypothesis, the investigators predict that children of parents who receive an active program will show improvements in anxiety symptoms across the 8 month study period.
Because the intervention strategies proposed are brief and easy-to-use, they could be easily implemented as part of routine practice, in much the same way as early intervention for other common childhood health conditions.
- Conditions
- Anxiety Disorders
- Being tested
- Project EMPOWER, Being Brave Parent Education, Sharing Feelings
- Keywords
- Anxiety, Parenting, Online Intervention, Child Mental Health
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project EMPOWERBehavioural
Project EMPOWER is a web-based, self-administered program for parents that takes about 20 minutes to complete.
Being Brave Parent EducationBehavioural
Being Brave Parent Education is an online, self-guided program which consists of three brief video-recorded lessons (approximately 20 minutes each) with accompanying knowledge checks and workbook on implementing parent-directed cognitive-behavioral therapy.
Sharing FeelingsBehavioural
A self-guided 20-minute educational control, that teaches parents about the importance of sharing feelings and about helpful versus unhelpful expression of emotion.
| Study group | Role | What they receive |
|---|---|---|
| Project Empower | Experimental | This program is a web-based, self-administered program for parents that takes about 20 minutes to complete. The program includes 5 elements based on the components of cognitive-behavioral therapy. Receives: Behavioral: Project EMPOWER |
| Being Brave | Experimental | This program is an online, self-guided program which consists of three brief video-recorded lessons (approximately 20 minutes each) with accompanying knowledge checks and workbook on implementing parent-directed cognitive-behavioral therapy. Receives: Behavioral: Being Brave Parent Education |
| Sharing Feelings | Sham comparator | This program is an online, self-guided 20-minute program, that teaches parents about the importance of sharing feelings and about helpful versus unhelpful expression of emotion. Receives: Behavioral: Sharing Feelings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pediatric Accommodation Scale, Parent-Report
The Pediatric Accommodation Scale is a parent-report of accommodation of their offspring's anxiety. Parents are asked to rate, on a 5-point scale from 0 (never) to 5 (always), the extent to which they accommodate their child's anxiety or avoidance behaviors. Total scores range from 0 to 25, with higher scores reflecting greater parental accommodation. Parents will report on their accommodation behaviors at baseline , 1-, 4-, and 8-months.
Measured: Change over 8-month follow-up (Baseline to 1-month, 4-month, and 8-month follow-up)
Secondary outcomes (1)
Change in Child Anxiety Symptoms, Parent-Report Total T-Score
To assess child anxiety symptoms, parents will complete either the Spence Child Anxiety Scale (SCAS-P) for children ages 6-7, the Spence Preschool Anxiety Scale (SPAS) for children ages 3-5, or the Infant-Toddler Social and Emotional Assessment Scale (ITSEA) for children aged 2. Each measure produces a Total Anxiety T-Score, which will be used as the secondary outcome.
Measured: Change over 8-month follow-up (Baseline to 1-month, 4-month, and 8-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Sep 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Eligible participants will be randomized (1:1:1 allocation ratio) to receive a three-session program with videos and a workbook or one of two single-session programs with activities. One of the three programs is considered a control condition, but all are education. All parents will repeat baseline evaluation measures 1- and 4-months post baseline. Those in the active groups will also repeat measures at 8-months. Those initially randomized to the control program can be re-randomized after 4 months to either of the active program and will complete subsequent 1- and 4-month follow-up measures post re-randomization.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madelaine R. Abel, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153250
- Sponsor's protocol ID
- 2025P001801
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2025
- Last updated
- 6 Oct 2026
- 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Self-Guided Interventions for Parents of Young Children With Anxiety
- ClinicalTrials.gov ID
- NCT07153250
- Acronym / sponsor ID
- 2025P001801
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety, Parenting, Online Intervention, Child Mental Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 3 Sep 2025 (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.
The investigators are doing this research to test whether parents of children ages 2-7 can better manage their child's anxiety by completing a brief, online, self-guided parent education program. One way to provide anxiety management skills to more children, and to potentially prevent worsening outcomes, is to offer online and self-guided educational programs that parents can complete without a clinician. This randomized trial will evaluate the effects of two brief, online, self-guided parent education programs designed to improve parents' understanding of anxiety and teach parents way to help their children cope with anxiety. Parents will be randomly assigned to one of the three programs. The main aim of the study is to examine whether the parent programs, compared to an educational control reduce parental accommodation of anxiety across a 1-, 4-, and 8-month follow-up period. As a secondary aim, the investigators will explore whether the parent programs reduce children's anxiety symptoms over the 8-month follow-up period. Results will inform the development of a scalable, low-cost model for promoting access to evidence-based treatment to young children.
Detailed description
Anxiety disorders are very common in children, affecting as many as 30% by adolescence. Even 10% of preschool-age children are already affected. These disorders cause distress and can interfere with academic, social, and family functioning. There are very effective treatments for anxiety disorders, but, on average, kids suffer for four years between onset of their anxiety symptoms and proper diagnosis and treatment. Young children often do not receive treatment because pediatricians, parents, and teachers do not realize that treatment can benefit them and because there is a shortage of providers trained to provide mental health care to young children. Given the importance of early intervention, the investigators are interested in whether parents can learn to better manage their child's anxiety by completing a brief, online, and self-guided parent education program.
Parents will be randomized to one of three self-guided education programs: A three-session program with videos and a workbook and two single-session programs with activities. The programs teach parents how to promote brave behaviors in their child (rather than allowing the child to avoid situations that make them nervous). One of the three programs is considered a control condition, but all are education, and parents will not know whether they are in the control condition until after the 4-month evaluation when they will have the chance to be reassigned to one of the other conditions. The investigators predict that parents who receive one of the active programs, compared to the control, will report greater reductions in parental accommodation across 1-, 4-, and 8-month follow-up. As a secondary hypothesis, the investigators predict that children of parents who receive an active program will show improvements in anxiety symptoms across the 8 month study period.
Because the intervention strategies proposed are brief and easy-to-use, they could be easily implemented as part of routine practice, in much the same way as early intervention for other common childhood health conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Eligible participants will be randomized (1:1:1 allocation ratio) to receive a three-session program with videos and a workbook or one of two single-session programs with activities. One of the three programs is considered a control condition, but all are education. All parents will repeat baseline evaluation measures 1- and 4-months post baseline. Those in the active groups will also repeat measures at 8-months. Those initially randomized to the control program can be re-randomized after 4 months to either of the active program and will complete subsequent 1- and 4-month follow-up measures post re-randomization.
| Arm | Type | Receives |
|---|---|---|
| Project Empower | Experimental | Behavioral: Project EMPOWERThis program is a web-based, self-administered program for parents that takes about 20 minutes to complete. The program includes 5 elements based on the components of cognitive-behavioral therapy. |
| Being Brave | Experimental | Behavioral: Being Brave Parent EducationThis program is an online, self-guided program which consists of three brief video-recorded lessons (approximately 20 minutes each) with accompanying knowledge checks and workbook on implementing parent-directed cognitive-behavioral therapy. |
| Sharing Feelings | Sham comparator | Behavioral: Sharing FeelingsThis program is an online, self-guided 20-minute program, that teaches parents about the importance of sharing feelings and about helpful versus unhelpful expression of emotion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Their child is between the age of 2 and 7 years-old
- Their child scores in the elevated range on an age-approrpiate anxiety screening measure
- Parents are English-speaking
- Parents are over the age of 18 years old
Key exclusion criteria (2 listed)
- Their child shows symptoms of suicidal or homicidal ideation, psychosis, or primary severe mood or behavior disorder (i.e., if treatment for another disorder other than anxiety is indicate prior to treatment for anxiety)
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 EMPOWERProject EMPOWER is a web-based, self-administered program for parents that takes about 20 minutes to complete. | Behavioural | Project Empower |
| Being Brave Parent EducationBeing Brave Parent Education is an online, self-guided program which consists of three brief video-recorded lessons (approximately 20 minutes each) with accompanying knowledge checks and workbook on implementing parent-directed cognitive-behavioral therapy. | Behavioural | Being Brave |
| Sharing FeelingsA self-guided 20-minute educational control, that teaches parents about the importance of sharing feelings and about helpful versus unhelpful expression of emotion. | Behavioural | Sharing Feelings |
Primary outcome
Change in Pediatric Accommodation Scale, Parent-Report
Time frame: Change over 8-month follow-up (Baseline to 1-month, 4-month, and 8-month follow-up)
The Pediatric Accommodation Scale is a parent-report of accommodation of their offspring's anxiety. Parents are asked to rate, on a 5-point scale from 0 (never) to 5 (always), the extent to which they accommodate their child's anxiety or avoidance behaviors. Total scores range from 0 to 25, with higher scores reflecting greater parental accommodation. Parents will report on their accommodation behaviors at baseline , 1-, 4-, and 8-months.
1 secondary outcome
Change in Child Anxiety Symptoms, Parent-Report Total T-Score
Time frame: Change over 8-month follow-up (Baseline to 1-month, 4-month, and 8-month follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project EMPOWER, Being Brave Parent Education and Sharing Feelings in people with Anxiety Disorders, run by Massachusetts General Hospital at 1 site in United States.
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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madelaine R Abel, PhD (617-643-9435, MGHResilienceStudy@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pediatric Accommodation Scale, Parent-Report (time frame: Change over 8-month follow-up (Baseline to 1-month, 4-month, and 8-month follow-up)). 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 6 Oct 2026.