Depressive Symptoms
Conditions
Brief summary
This pilot randomized controlled trial will examine the feasibility, acceptability and preliminary efficacy of an adolescent depression prevention program, Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST), in primary care.
Detailed description
Depression is prevalent during adolescence and is associated with negative outcomes. Most adolescent depression prevention programs require significant time and resources. To reduce the research-to-practice gap, the present study will test an adapted version of an evidence-based depression preventive intervention, Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), to promote its implementation in primary care (PC). Specifically, a brief, scalable prevention program, Brief IPT-AST (B-IPT-AST), will be tested in a pilot randomized controlled trial in PC. The pilot randomized controlled trial will include adolescents ages 13-17 with subthreshold depression scores on a depression screener, the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M), completed during an annual PC well-visit. Adolescents will be randomly assigned (2:1 allocation) to B-IPT-AST or services as usual (SAU). Members of the research team will deliver B-IPT-AST. Standardized measures for adolescents and legal guardians will be used to examine emotional outcomes (e.g., depression and anxiety symptoms). Standardized measures will be utilized to assess social processes (e.g., interpersonal conflict). All adolescents randomized to B-IPT-AST will complete a survey measuring acceptability of B-IPT-AST. Additionally, a subset of adolescents who participate in B-IPT-AST will be invited to participate in an hour-long qualitative interview to give feedback on their experiences with B-IPT-AST to inform any further modifications needed to enhance the program's feasibility and acceptability. Feasibility will also be assessed via recruitment and retention information and B-IPT-AST attendance logs.
Interventions
BEHAVIORALBrief Interpersonal Psychotherapy - Adolescent Skills Training (B-IPT-AST)
This is an adolescent depression prevention program consisting of 6 sessions (4 group and 2 individual sessions).
BEHAVIORALServices as usual (SAU)
Services as usual (SAU) involves any mental health services adolescents decide to receive in primary care or in the community. It is possible that adolescents in SAU may decide not to participate in any mental health services.
Sponsors
Children's Hospital of Philadelphia
The Klingenstein Third Generation Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
For Adolescent Participants 1. Adolescents ages 13 to 17 years. 2. Adolescents must be English-speaking. 3. Legal guardian permission (informed consent) and child consent/assent. 4. A score of 5-10 on the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M) at the primary care well-visit. 5. Access to a phone, computer, or other electronic device that could be used for study activities For Legal guardian Participants 1. Legal guardian of an adolescents ages 13 to 17 years who scored 5-10 on the PHQ-9-M at the primary care well-visit. 2. Consent to participate. 3. English-speaking. 4. Access to a phone, computer, and/or tablet to complete remote evaluations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI) | 0-6 Weeks Post-Intervention | A self-report measure, the Attitude Towards Intervention Questionnaire (ATI), will be completed by adolescents to assess acceptability of Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST) following the intervention. The ATI includes 11 Likert scale items and one open-ended item for providing additional feedback. Likert scales vary by item but are generally 3- or 5-point scales (e.g., very helpful to very unhelpful). Each item is interpreted on its own (e.g., the percentage of teens who found B-IPT-AST very or a little helpful) |
| Attendance | Weekly during B-IPT-AST | The number of individual and group B-IPT-AST sessions that teens attend will be tracked in order to report on the average number of group sessions attended (out of 4) for the total sample as well as the average number of individual sessions (out of 2) attended across the sample |
| Retention | Baseline, 0-6 Weeks Post-Intervention | To gauge feasibility, retention will be assessed by comparing the number of families who remain in the study through post-intervention to the number who consented. |
| Depression symptoms | Baseline, 0-6 Weeks Post-Intervention | Change in depression symptoms will be measured by the Center for Epidemiologic Studies-Depression Scale (CES-D) which assesses the frequency of 20 depressive symptoms over the past week; CES-D scores range from 0 to 60 (scores of 16 or higher are considered elevated); higher scores indicate more depression symptoms |
| Anxiety symptoms | Baseline, 0-6 Weeks Post-Intervention | Change in anxiety symptoms will be assessed by the Screen for Child Anxiety Related Disorders (SCARED), a 41-item scale assessing symptoms corresponding to different anxiety disorders; the study team will examine total scores and the following subscales: panic, generalized anxiety disorder, and social anxiety; total scores range from 0-82 (25 or higher indicates clinical range); panic scores range from 0-26 (7 or higher indicates clinical range); generalized anxiety disorder scores range from 0-18 (scores of 9 or higher indicates clinical range); social anxiety scale ranges from 0-14 (scores 8 or higher indicate clinical range) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Internalizing and externalizing symptoms | Baseline, 0-6 Weeks Post-Intervention | Changes in internalizing and externalizing symptoms will be assessed by the Pediatric Symptom Checklist (PSC-17), which will be completed by teens and caregivers; there is a total score (range of 0-34), internalizing subscale (0-24), externalizing subscale (0-20), and attention problems subscale (0-24); higher scores indicate more symptoms |
| Impairment (Child Report) | Baseline, 0-6 Weeks Post-Intervention | Change in impairment will be measured via teen report on the Columbia Impairment Scale (CIS), 13-item scale of overall functioning; scores range from 0-52; a score of 15 or higher is considered elevated impairment; higher scores represent greater impairment |
| Impairment (Parent Report) | Baseline, 0-6 Weeks Post-Intervention | Change in impairment will be measured via parent report on the Columbia Impairment Scale (CIS), 13-item scale of overall functioning; scores range from 0-52; a score of 15 or higher is considered elevated impairment; higher scores represent greater impairment |
| Perspective-taking | Baseline, 0-6 Weeks Post-Intervention | Changes in perspective taking will be measured by the Interpersonal Reactivity Index (IRI), a 7-item perspective-taking scale; scores range from 0-28 with higher scores representing more perspective taking |
| Social functioning | Baseline, 0-6 Weeks Post-Intervention | Changes in social functioning will be assessed by the Social Adjustment Scale-Self Report (SAS-SR), a 23-item scale of functioning in school (scores range from 6-30), with friends (scores range from 9-45), with family (scores range from 6-30), and dating (scores range from 2-10); a total score can also be computed (scores range from 23-115); higher scores indicate more difficulties in social functioning |
| Parent-child conflict (child report) | Baseline, 0-6 Weeks Post-Intervention | Changes in parent-child conflict will be assessed via teen report on the Conflict Behavior Questionnaire (CBQ), a 20-item questionnaire measuring conflict and negative communication between parents and adolescents; scores range from 0-20; higher scores indicate more conflict |
| Parent-child conflict (parent report) | Baseline, 0-6 Weeks Post-Intervention | Changes in parent-child conflict will be assessed via parent report on the Conflict Behavior Questionnaire (CBQ), a 20-item questionnaire measuring conflict and negative communication between parents and adolescents; scores range from 0-20; higher scores indicate more conflict |
Countries
United States
Contacts
CONTACTMolly F Davis, PhD
CONTACTJami F. Young, PhD
PRINCIPAL_INVESTIGATORMolly F Davis, PhD
Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine
Outcome results
None listed