NCT07219992 · Yale University
Parent-Based Treatment for Adolescent Anxiety
What this study is about
This study aims to test the effectiveness 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).
View original scientific description
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.
Interventions
BEHAVIORAL
Supportive Parenting for Anxious Childhood Emotions (SPACE)
Parent based treatment delivered by a therapist 12 weekly sessions with parents.
BEHAVIORAL
Parent Educational Support (PES)
Parent Educational Support: 12 weekly sessions with parents
Primary outcome measures
Mean Pediatric Anxiety Rating Scale (PARS) score
Time frame: Week 1 and 14
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.
Mean Screen for Child Anxiety Related Emotional Disorders (SCARED-C/P) score
Time frame: Week 1, 7 and 14
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.
Mean Child Anxiety Impact Scale (CAIS-C/P) score
Time frame: Week 1 and 14
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.
Clinical Global Impression Scale - Severity (CGI-S) and Improvement (CGI-I) scales score
Time frame: Week 1 and 14
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Exclusion criteria
- 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
- New Haven, Connecticut
Collaborators
MQ: Transforming Mental Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 21, 2025 · Source of record for eligibility and locations