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

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ClinicalTrials.gov Identifier: NCT06043271
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : March 15, 2024
Sponsor:
Collaborator:
AIM Youth Mental Health
Information provided by (Responsible Party):
Dina R. Hirshfeld-Becker, Massachusetts General Hospital

Study Description
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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, 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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Behavioral: The EMPOWER Program Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: A Single Session Parenting Intervention Administered to Parents of Children Waiting to Receive Cognitive Behavioral Therapy
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Parenting

Arms and Interventions
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Arm Intervention/treatment
Experimental: The EMPOWER Program
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.
 Behavioral: The EMPOWER Program
The EMPOWER Program is a web-based, self-administered SSI for parents that takes about 30 minutes to complete.
Other Name: Project EMPOWER
No Intervention: Waitlist as Usual
Participants in the control group will have their children remain on the waitlist until they are assigned to a therapist in the clinic.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Parents will be eligible to participate if:

  1. Their child has anxiety and/or Obsessive-Compulsive Disorder (OCD) (either subclinical or clinical), as determined by an initial screening
  2. Their child is between the age of 5 and 12 years-old
  3. Parents are English-speaking
  4. Parents are over the age of 18 years old

Exclusion Criteria:

Parents will be excluded if:

  1. 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)
  2. Their child is already receiving CBT (i.e., transfer cases from other CBT providers in the community).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043271


Contacts
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Contact: Dina R Hirshfeld-Becker, PhD 617-724-2572 dhirshfeld@mgb.org
Contact: Madelaine R Abel, PhD 617-643-9435

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
AIM Youth Mental Health
More Information
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Responsible Party: Dina R. Hirshfeld-Becker, Associate Professor of Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT06043271    
Other Study ID Numbers: 2023P001725
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dina R. Hirshfeld-Becker, Massachusetts General Hospital:
Anxiety
Accommodation
Parenting
Online Intervention
Single Session Intervention
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders