Yale Child Study Center
New Haven, Connecticut, 06519, United States
Location status: Recruiting
NCT Number: NCT07219992
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.
Interested in participating?
Request Info14 year–17 year
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06519, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Adolescent:
Parents:
Parent based treatment delivered by a therapist 12 weekly sessions with parents.
Parent Educational Support: 12 weekly sessions with parents
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.
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.
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.
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.
Time frame: Week 1, 8 and 14
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.
Time frame: Week 1 and 14
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.
Time frame: Week 1 and 14
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.
Time frame: Week 1 and 14
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.
Contact information is provided by the study sponsor or research team.
Alison Magnotti, MA
CONTACT
Rebecca Etkin, PhD
CONTACT
Yale University
Other
Testing a Novel Parent-Based Treatment for Adolescent Anxiety Disorders
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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