Parent-Based Treatment for Adolescent Anxiety

Официальное название

Testing a Novel Parent-Based Treatment for Adolescent Anxiety Disorders

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Supportive Parenting for Anxious Childhood Emotions (SPACE)
  Parent based treatment delivered by a therapist 12 weekly sessions with parents.
• Поведенческое Parent Educational Support (PES)
  Parent Educational Support: 12 weekly sessions with parents

Первичные конечные точки

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

Вторичные конечные точки (4)

• Mean Family Accommodation Scale - Anxiety (FASA-C/P) score [Срок оценки: Week 1, 8 and 14]
• Mean Family Assessment Device - General Functioning Scale (FAD-GF) score [Срок оценки: Week 1 and 14]
• Mean Parent Problem Checklist scale score [Срок оценки: Week 1 and 14]
• Mean Parent Behavior Inventory - Child and Parent Report (CRPBI/PRPBI) scale score [Срок оценки: Week 1 and 14]

Критерии участия

Критерии включения

• 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).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Yale Child Study Center — New Haven

Идентификаторы

NCT: NCT07219992 · 2000040413

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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