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Adverse Childhood Experiences Clinical Trial

Official title: Investigating the Effects of Youth Life Experiences on Reward and Cognitive Processes in Brief Interventions for Adolescent Depression

Status Completed

Clinical Trial Summary

The primary objective of this research is to examine two brief interventions for depression, Behavioral Activation (BA), and Problem Solving Therapy (PST), to investigate whether exposure to adverse childhood experiences influences change in the hypothesized target treatment mechanisms linked to each intervention. Research suggests that the treatment targets of BA (reward processing) may be well-matched for youths exposed to childhood adversity, due to disruptions in reward that are linked with adversity exposure. The investigators will examine the effects of youths' adverse life experiences on change in reward-related treatment targets in BA, and compare this to change in the treatment targets of PST, executive functioning processes. The first aim is to investigate the effects of childhood adversity on change in target treatment mechanisms in BA and PST. The second aim is to test whether changes in reward processes is specific to BA, and not PST, among youths exposed to adversity. The third aim is to test the match of BA for depression among youths exposed to adversity, by examining whether BA results in greater reductions in depression symptoms among youths with greater adversity exposure. The investigators will also test whether greater change in reward in associated with greater depression symptom reductions in BA, and not PST.

Clinical Trial Description

ASSESSMENT: Adolescents and a parent that is able to provide consent for participation will be contacted by research staff to discuss the research project and determine interest in study participation. With verbal permission from the parent, both the parent and adolescent will complete an eligibility screener over the phone. The eligibility screener includes demographic information, psychiatric history, and current depression symptoms (adolescent-report Patient Health Questionnaire-9 and the parent-report Children's Depression Inventory-2) to confirm that interested families meet initial inclusion criteria.

Baseline Assessment. A baseline assessment will be scheduled with all families. Informed consent and assent will be obtained prior to the start of any baseline assessment activities.

A diagnostic interview (Kiddie Schedule for Affective Disorders and Schizophrenia:

K-SADS-P/L) will be completed by a trained study staff member with each adolescent and their consenting parent. Diagnoses will be based on consensus ratings between adolescents and parents. Study staff will also administer the pediatric Columbia Suicide Severity Rating Scale, the Depression Rating Scale (embedded in K-SADS-P/L), and the Stress and Adversity Inventory (STRAIN).

Participants and parent will complete self-report questionnaires assessing depression symptom severity, sleep behavior, family and participant demographics, pubertal development, behavioral activation, and problem solving strategies and efficacy.

The Wechsler Abbreviated Scale for Intelligence-II (WASI-II), the Cambridge Neuropsychological Test Automated Battery (CANTAB), and reward processing outcome tasks will be administered to the adolescent by study staff in the lab setting.

Final study eligibility will be confirmed based on interviews and the WASI-II.

RANDOMIZATION: The investigators will use a simple randomization procedure whereby 50% of participants will be randomly assigned to Behavioral Activation (BA) and 50% to Problem Solving Therapy (PST).

INTERVENTIONS:

Behavioral Activation (BA) Therapy. Brief BA is a manualized individual psychotherapy adapted to a four-session structure for this pilot study. The first session provides psychoeducation about the value and reinforcement of various behaviors and treatment rationale. Three additional sessions include reviewing the youth's log of the activities they planned each week, assessing youths' values and planning further valued activities, and reviewing progress.

Problem Solving Therapy (PST). Brief PST is a manualized individual psychotherapy adapted to a four-session structure for this study. The first session provides psychoeducation on links between mood and managing social problems, as well as defining and identifying individual problems. Three additional sessions focus on generating solutions, decision making, implementing solutions, and evaluation and assessment of the outcomes of these solutions.

Adherence. A randomly selected 10% of the audio recorded sessions from each intervention will be reviewed and coded for therapist adherence to each protocol. Graduate and undergraduate student raters will be trained code sessions reliably, and the PI will conduct quarterly data checks to ensure coders remain reliable.

ENGAGEMENT OF TARGET TREATMENT MECHANISMS. Following the last therapy session, participants will repeat the four computerized behavioral tasks that were administered at baseline. Change in scores from pre- to post-intervention reflects change in the target treatment mechanisms. Youths will complete depression rating scales online at post-treatment, and again at one-month follow-up to assess the effects of the intervention on depression symptom levels. ;

Related Conditions & MeSH terms

• Adverse Childhood Experiences
• Depression
• Depression in Adolescence
• Depressive Disorder

• NCT number: NCT04719949
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Completed
• Phase: N/A
• Start date: February 9, 2021
• Completion date: September 30, 2023