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A Single Session Parenting Intervention for Children on a Outpatient Therapy Waitlist

Primary Purpose

Anxiety Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The EMPOWER Program
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Anxiety, Accommodation, Parenting, Online Intervention, Single Session Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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).

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The EMPOWER Program

Waitlist as Usual

Arm Description

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.

Participants in the control group will have their children remain on the waitlist until they are assigned to a therapist in the clinic.

Outcomes

Primary Outcome Measures

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 the extent to which they accommodate their child's anxiety or avoidance behaviors with higher scores reflecting greater parental accommodation. Parents will report on their accommodation behaviors at baseline and 2-weeks follow-up.

Secondary Outcome Measures

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.

Full Information

First Posted
September 12, 2023
Last Updated
September 12, 2023
Sponsor
Massachusetts General Hospital
Collaborators
AIM Youth Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT06043271
Brief Title
A Single Session Parenting Intervention for Children on a Outpatient Therapy Waitlist
Official Title
A Single Session Parenting Intervention Administered to Parents of Children Waiting to Receive Cognitive Behavioral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
AIM Youth Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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, we will explore whether the SSI reduces children's anxiety symptoms over the first 6 months of CBT. We 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. We 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, we 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Anxiety, Accommodation, Parenting, Online Intervention, Single Session Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The EMPOWER Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist as Usual
Arm Type
No Intervention
Arm Description
Participants in the control group will have their children remain on the waitlist until they are assigned to a therapist in the clinic.
Intervention Type
Behavioral
Intervention Name(s)
The EMPOWER Program
Other Intervention Name(s)
Project EMPOWER
Intervention Description
The EMPOWER Program is a web-based, self-administered SSI for parents that takes about 30 minutes to complete.
Primary Outcome Measure Information:
Title
Change in Pediatric Accommodation Scale, Parent-Report
Description
The Pediatric Accommodation Scale is a parent-report of accommodation of their offspring's anxiety. Parents are asked to rate the extent to which they accommodate their child's anxiety or avoidance behaviors with higher scores reflecting greater parental accommodation. Parents will report on their accommodation behaviors at baseline and 2-weeks follow-up.
Time Frame
Baseline to 2-week follow up
Secondary Outcome Measure Information:
Title
Change in Spence Child Anxiety Scale, Parent-Report Total score
Description
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.
Time Frame
Baseline to 2-week follow up; Change over first 6 months of CBT (intake to 3- and 6-month follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina R Hirshfeld-Becker, PhD
Phone
617-724-2572
Email
dhirshfeld@mgb.org
First Name & Middle Initial & Last Name or Official Title & Degree
Madelaine R Abel, PhD
Phone
617-643-9435
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Single Session Parenting Intervention for Children on a Outpatient Therapy Waitlist

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