Parent-Based Treatment for Adolescent Anxiety

Yale University

Status: Enrolling

Conditions: Anxiety Disorder of Adolescence

Treatments: Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE); Behavioral: Parent Educational Support (PES)

Study type: Interventional

Funder types: Other

Identifiers

NCT07219992

2000040413

Details and patient eligibility

About

This study aims to test the efficacy of a parent-only approach to treating anxiety disorders in adolescents: SPACE (Supportive Parenting for Anxious Childhood Emotions). The comparator is another parent-based approach, PES (Parent Education and Support). The study design is a randomized controlled trial with 2 treatment arms and 3 assessment points (pre, post, and follow-up) using questionnaire data and clinical interviews.

Full description

The primary objective is to examine if SPACE is more efficacious than PES in reducing adolescent anxiety symptoms. The secondary objective is to examine if SPACE produces greater change than PES in improving family accommodation and family functioning.

SPACE and PES will be delivered over 12 sessions: Sessions 1-6 (once weekly), a mid-treatment assessment, Sessions 7-12 (once weekly), and a Post-treatment assessment.

Sessions can be attended in person or via Zoom.

Enrollment: 108 estimated patients

Sex: All

Ages: 14 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet criteria for a primary DSM-5 AD, including separation anxiety disorder, social anxiety disorder, generalized anxiety disorder, specific phobia, panic disorder, and agoraphobia (determined by the ADIS-C/P).
• Cease all other psychosocial treatment, upon consultation with the project staff and service provider.
• Not currently use any psychotropic medication, other than a stable dose (i.e., same dose for a minimum of 6 months prior to enrollment; no changes during course of the study) of a stimulant medication or selective serotonin reuptake inhibitor (SSRI).
• Have an eligible and willing participating parent (see parent exclusions below).

Exclusion criteria

Adolescent:

• Meet criteria for any DSM-5 disorder more impairing than the most impairing AD (determined by the ADIS-C/P).
• Have any of the following disorders: autism spectrum disorder; intellectual disability; neurocognitive disorders; bipolar disorder; schizophrenia and other psychotic disorders; and alcohol and substance use disorders (determined by the Health History Form and ADIS-C/P).
• Report a suicide attempt in the last 3 months, or current suicide intent and plans (determined by the ASQ).
• Be a victim of past or present undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services.
• Not have sufficient proficiency with the English language to complete assessments.

Parents:

• Have any of the following: intellectual disability; neurocognitive disorders; untreated bipolar disorder; untreated schizophrenia and other psychotic disorders; and untreated alcohol and substance use disorders (determined by the Health History Form).
• Not be living with the adolescent at least 50% of the time for at least one year prior to enrollment.
• Not have sufficient proficiency with the English language to complete assessments and treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Supportive Parenting for Anxious Childhood Emotions (SPACE)

Experimental group

Description:

A parent-only approach to treating anxiety disorders in adolescents delivered over 12 sessions.

Treatment:

Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE)

Parent Education and Support (PES)

Active Comparator group

Description:

Parent-based approach comparator arm delivered over 12 sessions.

Treatment:

Behavioral: Parent Educational Support (PES)