Anxiety DisordersNCT06043271
A Single Session Parenting Intervention for Children on a Outpatient Therapy Waitlist
A study testing The EMPOWER Program in people with Anxiety Disorders, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Cognitive Behavioral Therapy (CBT) is the treatment of choice for youth anxiety. However, up to 80% of youth with anxiety disorders do not access the services they need. Child CBT clinics nationwide have extremely long waits, on the order of 10-12 months. 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?
- The EMPOWER Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 Apr 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parents will be eligible to participate if:
- Their child has anxiety and/or Obsessive-Compulsive Disorder (OCD) (either subclinical or clinical), as determined by an initial screening
- Their child is between the age of 5 and 12 years-old
- 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)
- Their child is already receiving CBT (i.e., transfer cases from other CBT providers in the community).
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Single Session Parenting Intervention Administered to Parents of Children Waiting to Receive Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) is the treatment of choice for youth anxiety. However, up to 80% of youth with anxiety disorders do not access the services they need. Child CBT clinics nationwide have extremely long waits, on the order of 10-12 months. This leads to a vicious cycle, as children waiting for care experience worsening symptoms and decreased motivation, so that by the time they access care, their needs are more intensive and the treatment lasts longer and it takes longer for new children to be able to be assigned. Recently, single-session interventions (SSIs) have been developed that enable children to access CBT skills. The proposed randomized trial will evaluate the effects of a brief, web-based, self-guided SSI designed to reduce parent accommodation of children's anxiety, a parenting behavior that has been shown to maintain and worsen child anxiety. The main aim of the study is to examine whether the SSI reduces parent accommodation. As a secondary aim, the investigators will explore whether the SSI reduces children's anxiety symptoms over the first 6 months of CBT. The investigators will recruit parents of children who are on the waitlist to receive outpatient CBT. Results may suggest a promising approach to intervene with parents and children waiting to receive therapy.
Read the detailed description
Anxiety disorders affect as many as 30% of youth and are associated with academic and social impairment and onset of comorbid mood and substance use disorders. Cognitive Behavioral Therapy (CBT) is the treatment of choice for anxiety, achieving remission rates of 60% alone or 80% in combination with medication. However, up to 80% of youth with anxiety disorders do not access the services they need. CBT clinics nationwide have extremely long waits, on the order of 10-12 months. This leads to a vicious cycle, as children waiting for care experience worsening symptoms and decreased motivation, so that by the time they access care, their needs are more intensive and the treatment lasts longer and it takes longer for new children to be able to be assigned.
One proposed pathway to increase access to mental health services is through the delivery of single session interventions (SSIs). SSIs are defined as structured programs that involve one visit or mental health encounter. SSIs are brief, scalable, and there is extensive evidence demonstrating that they can decrease anxiety among children and adolescents recruited from the general community. Importantly, SSIs can be delivered in a self-guided online format. Thus, they are flexible in delivery and content and uniquely suited to be implemented in an outpatient mental health setting for patients on long outpatient therapy waitlists.
One such SSI is the online, self-guided, EMPOWER Program. This SSI takes 30 minutes and targets parent accommodation, a tendency to facilitate avoidance and enable anxious coping that has been shown to maintain and worsen child anxiety and OCD. This SSI has shown promise in reducing parent accommodation of children's anxiety in non-clinical community samples. However, it has not yet been tested among children seeking psychotherapy services who present with higher acuity. Thus, the goal of this project is to test the EMPOWER SSI delivered to parents of children on the waitlist for outpatient CBT. Parent participants will be randomized to either the SSI or to remain on the waitlist as usual for monitoring. The investigators predict that parents who receive the SSI, compared to the control group, will report (a) greater reductions in accommodation from baseline to 2-week follow-up. As a secondary hypothesis, the investigators will explore whether children of parents who received the SSI will show more rapid improvements in anxiety symptoms over the first 6 months of CBT.
- Conditions
- Anxiety Disorders
- Being tested
- The EMPOWER Program
- Keywords
- Anxiety, Accommodation, Parenting, Online Intervention, Single Session Intervention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The EMPOWER ProgramBehavioural
Also called Project EMPOWER
The EMPOWER Program is a web-based, self-administered SSI for parents that takes about 30 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| The EMPOWER Program | Experimental | The EMPOWER Program (Sung et al., 2021) is a web-based, self-administered SSI for parents that takes about 30 minutes to complete. The SSI includes 5 elements based on the components of CBT. Receives: Behavioral: The EMPOWER Program |
| Waitlist as Usual | No intervention | Participants in the control group will have their children remain on the waitlist until they are assigned to a therapist in the clinic. |
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 and 2-weeks follow-up.
Measured: Baseline to 2-week follow up
Secondary outcomes (1)
Change in Spence Child Anxiety Scale, Parent-Report Total score
The Spence Child Anxiety Scale is a 38 item parent-report assessment of child anxiety symptoms. Parents are asked to rate on a 4-point scale (0-3) the presence of different anxiety symptoms in their children. Items are summed and higher scores reflect more severe child anxiety symptoms. Parents will report on their children's anxiety symptoms at baseline and 2-week follow-up. After children from the waitlist are assigned to a therapist to begin CBT, parents will complete this questionnaire prior to treatment onset (intake), and at 3- and 6-months follow-up.
Measured: Baseline to 2-week follow up; Change over first 6 months of CBT (intake to 3- and 6-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 posted21 Sep 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2025
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 allocation ratio) to receive the EMPOWER Program single session intervention (SSI) or to have their child remain on the clinic waitlist as usual.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AIM Youth Mental Health, American Psychological Foundation
- Responsible party
- Principal investigator, Madelaine R. Abel, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043271
- Sponsor's protocol ID
- 2023P001725
- Status last verified
- Apr 2026
- First submitted
- 12 Sep 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abel MR, Schleider JL, Sung J, D'Amico AA, Hirshfeld-Becker DR. Supporting children on therapy waitlists: A randomized controlled trial of a web-based parent-focused single session intervention for child anxiety. Behav Res Ther. 2026 Aug;203:105107. doi: 10.1016/j.brat.2026.105107. Epub 2026 Jun 26.
PubMed 42372373
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Session Parenting Intervention Administered to Parents of Children Waiting to Receive Cognitive Behavioral Therapy
- ClinicalTrials.gov ID
- NCT06043271
- Acronym / sponsor ID
- 2023P001725
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety, Accommodation, Parenting, Online Intervention, Single Session Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- AIM Youth Mental Health, American Psychological Foundation
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 21 Sep 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.
Cognitive Behavioral Therapy (CBT) is the treatment of choice for youth anxiety. However, up to 80% of youth with anxiety disorders do not access the services they need. Child CBT clinics nationwide have extremely long waits, on the order of 10-12 months. This leads to a vicious cycle, as children waiting for care experience worsening symptoms and decreased motivation, so that by the time they access care, their needs are more intensive and the treatment lasts longer and it takes longer for new children to be able to be assigned. Recently, single-session interventions (SSIs) have been developed that enable children to access CBT skills. The proposed randomized trial will evaluate the effects of a brief, web-based, self-guided SSI designed to reduce parent accommodation of children's anxiety, a parenting behavior that has been shown to maintain and worsen child anxiety. The main aim of the study is to examine whether the SSI reduces parent accommodation. As a secondary aim, the investigators will explore whether the SSI reduces children's anxiety symptoms over the first 6 months of CBT. The investigators will recruit parents of children who are on the waitlist to receive outpatient CBT. Results may suggest a promising approach to intervene with parents and children waiting to receive therapy.
Detailed description
Anxiety disorders affect as many as 30% of youth and are associated with academic and social impairment and onset of comorbid mood and substance use disorders. Cognitive Behavioral Therapy (CBT) is the treatment of choice for anxiety, achieving remission rates of 60% alone or 80% in combination with medication. However, up to 80% of youth with anxiety disorders do not access the services they need. CBT clinics nationwide have extremely long waits, on the order of 10-12 months. This leads to a vicious cycle, as children waiting for care experience worsening symptoms and decreased motivation, so that by the time they access care, their needs are more intensive and the treatment lasts longer and it takes longer for new children to be able to be assigned.
One proposed pathway to increase access to mental health services is through the delivery of single session interventions (SSIs). SSIs are defined as structured programs that involve one visit or mental health encounter. SSIs are brief, scalable, and there is extensive evidence demonstrating that they can decrease anxiety among children and adolescents recruited from the general community. Importantly, SSIs can be delivered in a self-guided online format. Thus, they are flexible in delivery and content and uniquely suited to be implemented in an outpatient mental health setting for patients on long outpatient therapy waitlists.
One such SSI is the online, self-guided, EMPOWER Program. This SSI takes 30 minutes and targets parent accommodation, a tendency to facilitate avoidance and enable anxious coping that has been shown to maintain and worsen child anxiety and OCD. This SSI has shown promise in reducing parent accommodation of children's anxiety in non-clinical community samples. However, it has not yet been tested among children seeking psychotherapy services who present with higher acuity. Thus, the goal of this project is to test the EMPOWER SSI delivered to parents of children on the waitlist for outpatient CBT. Parent participants will be randomized to either the SSI or to remain on the waitlist as usual for monitoring. The investigators predict that parents who receive the SSI, compared to the control group, will report (a) greater reductions in accommodation from baseline to 2-week follow-up. As a secondary hypothesis, the investigators will explore whether children of parents who received the SSI will show more rapid improvements in anxiety symptoms over the first 6 months of CBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible participants will be randomized (1:1 allocation ratio) to receive the EMPOWER Program single session intervention (SSI) or to have their child remain on the clinic waitlist as usual.
| Arm | Type | Receives |
|---|---|---|
| The EMPOWER Program | Experimental | Behavioral: The EMPOWER ProgramThe EMPOWER Program (Sung et al., 2021) is a web-based, self-administered SSI for parents that takes about 30 minutes to complete. The SSI includes 5 elements based on the components of CBT. |
| Waitlist as Usual | No intervention | –Participants in the control group will have their children remain on the waitlist until they are assigned to a therapist in the clinic. |
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 has anxiety and/or Obsessive-Compulsive Disorder (OCD) (either subclinical or clinical), as determined by an initial screening
- Their child is between the age of 5 and 12 years-old
- Parents are English-speaking
- Parents are over the age of 18 years old
Key exclusion criteria (3 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)
- Their child is already receiving CBT (i.e., transfer cases from other CBT providers in the community).
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 |
|---|---|---|
| The EMPOWER ProgramAlso: Project EMPOWERThe EMPOWER Program is a web-based, self-administered SSI for parents that takes about 30 minutes to complete. | Behavioural | The EMPOWER Program |
Primary outcome
Change in Pediatric Accommodation Scale, Parent-Report
Time frame: Baseline to 2-week 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 and 2-weeks follow-up.
1 secondary outcome
Change in Spence Child Anxiety Scale, Parent-Report Total score
Time frame: Baseline to 2-week follow up; Change over first 6 months of CBT (intake to 3- and 6-month follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Derived from this study: PubMed 42372373Abel MR, Schleider JL, Sung J, D'Amico AA, Hirshfeld-Becker DR. Supporting children on therapy waitlists: A randomized controlled trial of a web-based parent-focused single session intervention for child anxiety. Behav Res Ther. 2026 Aug;203:105107. doi: 10.1016/j.brat.2026.105107. Epub 2026 Jun 26.
- Individual participant dataSharing planned: No
Related trials for Anxiety Disorders
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Stress and Anxiety Effects on Valuation
Reward Value Level
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The EMPOWER Program 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 3 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: finished, as of the sponsor's last update on 17 Apr 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pediatric Accommodation Scale, Parent-Report (time frame: Baseline to 2-week follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06043271, which also lists 1 linked publication.
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 Apr 2026.