Parent-Based Treatment for Adolescent Anxiety
Recruiting · NCT07219992 · Interventional (participants receive a specific treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
Parent Educational Support (PES)Supportive Parenting for Anxious Childhood Emotions (SPACE)
What this trial is 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.
Who can take part
Age range
14 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Yale Child Study Center - New Haven, Connecticut, United States