Parent-Based Treatment for Adolescent Anxiety

NCT07219992 | Recruiting

• 1 other identifier: 2000040413
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Mean Pediatric Anxiety Rating Scale (PARS) score

  This scale measures anxiety symptoms on 7 dimensions (e.g., avoidance, severity) from 0 ("minimal") to 5 ("extreme"). Total scores range from 0 - 35. Higher scores indicate greater anxiety severity.

  Week 1 and 14

• Mean Screen for Child Anxiety Related Emotional Disorders (SCARED-C/P) score

  This scale assesses adolescent anxiety symptoms on a 3-point scale (0 "not true/hardly ever true" to 2 "very true/often true") with total score range = 0 - 82. Higher scores suggest greater anxiety symptoms.

  Week 1, 7 and 14

• Mean Child Anxiety Impact Scale (CAIS-C/P) score

  This scale assesses adolescent anxiety that specifically captures impairment related to anxiety across important domains of functioning. Adolescents and parents rate items on a 4-point scale (0 "not at all" to 3 "very much"); total score range = 0 - 81. Higher scores suggest greater anxiety symptoms.

  Week 1 and 14

• Clinical Global Impression Scale - Severity (CGI-S) and Improvement (CGI-I) scales score

  This measure will be used to assess overall severity (CGI-S) and improvement (CGI-I) in adolescent anxiety. Total score range for each is 1-7. (Scores of 1 ("very much improved/normal") or 2 ("much improved/borderline ill") indicate a positive treatment response; all other responses are considered negative responses. Higher scores indicate worse outcome.

  Week 1 and 14

Secondary Outcomes (4)

• Mean Family Accommodation Scale - Anxiety (FASA-C/P) score

  Week 1, 8 and 14

• Mean Family Assessment Device - General Functioning Scale (FAD-GF) score

  Week 1 and 14

• Mean Parent Problem Checklist scale score

  Week 1 and 14

• Mean Parent Behavior Inventory - Child and Parent Report (CRPBI/PRPBI) scale score

  Week 1 and 14

Study Arms (2)

Supportive Parenting for Anxious Childhood Emotions (SPACE)

EXPERIMENTAL

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

Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE)

Parent Education and Support (PES)

ACTIVE COMPARATOR

Parent-based approach comparator arm delivered over 12 sessions.

Behavioral: Parent Educational Support (PES)

Interventions

Supportive Parenting for Anxious Childhood Emotions (SPACE) BEHAVIORAL

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

Supportive Parenting for Anxious Childhood Emotions (SPACE)

Parent Educational Support (PES) BEHAVIORAL

Parent Educational Support: 12 weekly sessions with parents

Parent Education and Support (PES)

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• MQ: Transforming Mental Health: collaborator

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06519, United States

RECRUITING

Study Officials

• Rebecca Etkin, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Etkin, PhD

CONTACT

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

Alison Magnotti, MA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Adolescent participants and their parents will be enrolled.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 23, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)