Recruiting

SPACE vs. PES

Sponsor:

Yale University

Code:

NCT07219992

Conditions

Anxiety Disorder of Adolescence

Eligibility Criteria

Sex: All

Age: 14 - 17

Healthy Volunteers: Not accepted

Interventions

Supportive Parenting for Anxious Childhood Emotions (SPACE)

Parent Educational Support (PES)

Study Details

Brief summary:

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.

Conditions

Anxiety Disorder of Adolescence

Study ID

NCT07219992

Start date

Nov 1, 2025

Status verified date

Nov, 2025

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Supportive Parenting for Anxious Childhood Emotions (SPACE)

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

active comparator: Parent Education and Support (PES)

Parent-based approach comparator arm delivered over 12 sessions.

Interventions

Supportive Parenting for Anxious Childhood Emotions (SPACE)

Parent based treatment delivered by a therapist 12 weekly sessions with parents.

Parent Educational Support (PES)

Parent Educational Support: 12 weekly sessions with parents

Primary outcome measure

  • Mean Pediatric Anxiety Rating Scale (PARS) score [ Time Frame: Week 1 and 14 ]
  • Mean Screen for Child Anxiety Related Emotional Disorders (SCARED-C/P) score [ Time Frame: Week 1, 7 and 14 ]
  • Mean Child Anxiety Impact Scale (CAIS-C/P) score [ Time Frame: Week 1 and 14 ]
  • Clinical Global Impression Scale - Severity (CGI-S) and Improvement (CGI-I) scales score [ Time Frame: Week 1 and 14 ]

Central Contacts and Locations

Central contacts

Rebecca Etkin, PhD

203-737-4644Rebecca.etkin@yale.edu

Alison Magnotti, MA

203-737-4644alison.magnotti@yale.edu

Locations

Yale Child Study Center

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Rebecca Etkin, PhD

203-737-4644anxiety.csc@yale.edu

More Information

Sponsor

Yale University

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-11-21.