Parent-Based Treatment for Adolescent Anxiety
ConditionAnxiety Disorder of Adolescence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-17
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Supportive Parenting for Anxious Childhood Emotions (SPACE)
BehavioralParent based treatment delivered by a therapist 12 weekly sessions with parents.
Parent Educational Support (PES)
BehavioralParent Educational Support: 12 weekly sessions with parents
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Supportive Parenting for Anxious Childhood Emotions (SPACE)Experimental treatment 1 intervention
Group B: Parent Education and Support (PES)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 1 and 142
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.
Time frame
Week 1, 7 and 143
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.
Time frame
Week 1 and 144
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.
Time frame
Week 1 and 14Secondary outcomes
1
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.
Time frame
Week 1, 8 and 142
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.
Time frame
Week 1 and 143
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.
Time frame
Week 1 and 144
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.
Time frame
Week 1 and 14Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
MQ: Transforming Mental Health
Collaborator
Source ClinicalTrials.gov