Anxiety Disorder of AdolescenceNCT07219992
Parent-Based Treatment for Adolescent Anxiety
A study testing Supportive Parenting for Anxious Childhood Emotions (SPACE) and Parent Educational Support (PES) in people with Anxiety Disorder of Adolescence, run by Yale University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Anxiety Disorder of Adolescence
- What is being tested?
- Supportive Parenting for Anxious Childhood Emotions (SPACE) and Parent Educational Support (PES)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale Child Study Center
New Haven, Connecticut, 06519
Rebecca Etkin, PhD, 203-737-4644, anxiety.csc@yale.edu
About this study
Official title: Testing a Novel Parent-Based Treatment for Adolescent Anxiety Disorders
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.
Read the detailed description
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.
- Conditions
- Anxiety Disorder of Adolescence
- Being tested
- Supportive Parenting for Anxious Childhood Emotions (SPACE), Parent Educational Support (PES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Parenting for Anxious Childhood Emotions (SPACE)Behavioural
Parent based treatment delivered by a therapist 12 weekly sessions with parents.
Parent Educational Support (PES)Behavioural
Parent Educational Support: 12 weekly sessions with parents
| Study group | Role | What they receive |
|---|---|---|
| Supportive Parenting for Anxious Childhood Emotions (SPACE) | Experimental | A parent-only approach to treating anxiety disorders in adolescents delivered over 12 sessions. Receives: Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE) |
| Parent Education and Support (PES) | Active comparator | Parent-based approach comparator arm delivered over 12 sessions. Receives: Behavioral: Parent Educational Support (PES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 1 and 14
Secondary outcomes (4)
Mean Family Accommodation Scale - Anxiety (FASA-C/P) score
This scale assesses family accommodation. Adolescents and parents rate 9 items on a 5-point scale, 0 "never" to 4 "daily"; total score range = 0 - 36. Higher scores indicate more accommodation.
Measured: Week 1, 8 and 14
Mean Family Assessment Device - General Functioning Scale (FAD-GF) score
This scale will measure of overall family functioning. Adolescents and parents rate 12-items on a 4-point scale (0 "strongly disagree" - 3 "strongly agree"). Total score range 0-3. Higher scores indicate more unhealthy family functioning.
Measured: Week 1 and 14
Mean Parent Problem Checklist scale score
This scale will measure co-parenting and assesses parents' ability to cooperate and work together in family management. Parents rate 16 items on a yes/no scale to form the Overall Problems scale, total score range = 0 - 16. Higher scores indicate greater conflict. Parents also rate each "yes" on a 7-point scale (1 "not at all" to 7 "very much") to form the Extent scale. Total score range 16-112. Higher scores indicate greater extent of a problem for them and their partner.
Measured: Week 1 and 14
Mean Parent Behavior Inventory - Child and Parent Report (CRPBI/PRPBI) scale score
This scale will measure parent-child relationship quality. Adolescents and parents respectively rate 30-items assessing perceived parental behaviors on a scale from 0 ("Not like") to 2 ("A lot like"). Total score range = 0 to 2 with higher scores indicating better relationship quality.
Measured: Week 1 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2025
- Study start1 Nov 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorder of AdolescenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- MQ: Transforming Mental Health
- Responsible party
- Sponsor
- Investigators
- Rebecca Etkin, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219992
- Sponsor's protocol ID
- 2000040413
- Status last verified
- Nov 2026
- First submitted
- 20 Oct 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Novel Parent-Based Treatment for Adolescent Anxiety Disorders
- ClinicalTrials.gov ID
- NCT07219992
- Acronym / sponsor ID
- 2000040413
- Conditions
- Anxiety Disorder of Adolescence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- MQ: Transforming Mental Health
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 23 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive Parenting for Anxious Childhood Emotions (SPACE) | Experimental | Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE)A parent-only approach to treating anxiety disorders in adolescents delivered over 12 sessions. |
| Parent Education and Support (PES) | Active comparator | Behavioral: Parent Educational Support (PES)Parent-based approach comparator arm delivered over 12 sessions. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive Parenting for Anxious Childhood Emotions (SPACE)Parent based treatment delivered by a therapist 12 weekly sessions with parents. | Behavioural | Supportive Parenting for Anxious Childhood Emotions (SPACE) |
| Parent Educational Support (PES)Parent Educational Support: 12 weekly sessions with parents | Behavioural | Parent Education and Support (PES) |
Primary outcome
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.
4 secondary outcomes
Mean Family Accommodation Scale - Anxiety (FASA-C/P) score
Time frame: Week 1, 8 and 14
Mean Family Assessment Device - General Functioning Scale (FAD-GF) score
Time frame: Week 1 and 14
Mean Parent Problem Checklist scale score
Time frame: Week 1 and 14
Mean Parent Behavior Inventory - Child and Parent Report (CRPBI/PRPBI) scale score
Time frame: Week 1 and 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Anxiety Disorder of Adolescence
Not yet recruiting
Parent-Based Intervention for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
Anxiety Disorder of Adolescence, Avoidant / Restrictive Food Intake Disorder
Not yet recruiting
Effects of Transcranial Direct Current Stimulation and Manual Therapy on Musculoskeletal Pain in Adolescent Dancers
Musculoskeletal Pain, Chronic Pain
Active, not recruiting
Effectiveness of a Guided Mental Health Chatbot for Youth Living in Lithuania
Symptoms of Depression and Anxiety
Not yet recruiting
Virtual Reality to Reduce Anxiety During Thoracic Epidural Placement.
Preoperative Anxiety Score
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca Etkin, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Parenting for Anxious Childhood Emotions (SPACE) and Parent Educational Support (PES) in people with Anxiety Disorder of Adolescence, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Etkin, PhD (203-737-4644, Rebecca.etkin@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Pediatric Anxiety Rating Scale (PARS) score (time frame: Week 1 and 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.