Anxiety, Depression
Conditions
Keywords
Child, adolescent, anxiety, depression, internalizing, cognitive behavioral therapy, pediatric primary care
Brief summary
The purpose of this study is to determine whether a brief (12 week) psychological treatment program, based in primary care, can help youths struggling with anxiety and/or depression. This brief cognitive behavioral therapy program will be compared to enhanced referral to specialty mental health care.
Detailed description
Mood and anxiety disorders in childhood and adolescence are disabling, distressing, and prevalent and produce added costs to health systems. This two-site randomized controlled trial will test the effects of a brief cognitive behavioral therapy (BCBT) protocol (8-12 sessions) in a large sample (N=210) of children and adolescents (age 8-16) presenting with anxiety and/or depression in primary care. Clinical and cost-effectiveness of BCBT will be compared to a plausible public health alternative - enhanced referral to specialty mental health care (SMHC). This investigation is noteworthy in adopting a deployment-focused model and testing this intervention early in its development within a real world context (primary care) and against a plausible public health comparison condition (SMHC) relevant for future treatment dissemination.
Interventions
BCBT: 8-12 sessions over 16 weeks of cognitive-behavioral therapy administered by Master's-level clinicians in primary care setting
SMHC: specialty mental health care referrals provided
Sponsors
Study design
Eligibility
Inclusion criteria
* meet full or probable diagnostic criteria for Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia, Major Depression, Dysthymic Disorder, or Minor Depression * age 8.0 to 16.9 * live with legal, consenting guardian for at least 6 months
Exclusion criteria
* youths requiring alternate intervention (e.g., youths with bipolar disorder, psychosis, active suicidal ideation with plan, PTSD, substance dependence, current physical or sexual abuse, or mental retardation * suffer from serious or unstable physical illness (e.g., uncontrolled diabetes) * currently in active, alternate intervention for anxiety or depression (e.g., antidepressant use)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Global Impression | measured at baseline (week 0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Anxiety Rating Scale | measured at baseline (week 0) | — |
| Children's Depression Rating Scale - Revised | measured at baseline (week 0) | — |
| Health Utilities Index | measured at baseline (week 0) | This measure will aid in cost-effectiveness analyses. |
Countries
United States