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

NCT06043271 | Completed

• 1 other identifier: 2023P001725
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Keywords

Anxiety; Accommodation; Parenting; Online Intervention; Single Session Intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 2-week follow up

Secondary Outcomes (1)

• Change in Spence Child Anxiety Scale, Parent-Report Total score

  Baseline to 2-week follow up; Change over first 6 months of CBT (intake to 3- and 6-month follow-up)

Study Arms (2)

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.

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.

Interventions

The EMPOWER Program BEHAVIORAL

The EMPOWER Program is a web-based, self-administered SSI for parents that takes about 30 minutes to complete.

Also known as: Project EMPOWER

The EMPOWER Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• AIM Youth Mental Health: collaborator
• American Psychological Foundation: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Model Details: 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.

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: April 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)