Clinical trial NCT04719897: Life Experiences in Adolescents and the Development of Skills
Official title: Effects of Stressful Life Experiences on the Acquisition of a Coping Skill in Adolescents With Elevated Depression Symptoms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression in Adolescence
Adverse Childhood Experiences
Keywords: Depression
Adolescents
Cognitive Behavioral Therapy
Childhood Adversity
Cognitive Function
Psychophysiology
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-01-22
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of this study is to assess acquisition and retention of a Cognitive Behavioral Therapy (CBT)-based "cognitive restructuring" skill, among young adolescents (12-15 years of age) with elevated depression symptoms and with population-level variability in lifetime exposure to adverse childhood experiences. This study uses a repeated-measures, longitudinal design to investigate associations between adversity exposure and learning-related cognitive control processes in the context of elevated depression (Aim 1). Adversity exposure and cognitive control will be examined as direct predictors of cognitive restructuring skill acquisition and skill retention over six-months; an indirect pathway from adversity to skill acquisition through cognitive control will also be examined (Aim 2). The study also includes exploration of key characteristics of adversity, namely the type (threat of harm versus deprivation of resources) and developmental timing of exposure, as distinct predictors of skill acquisition (exploratory Aim 3).

Detailed description: ASSESSMENT: With verbal permission from the parent, both the interested parent and adolescent will complete an eligibility screener over the phone. The eligibility screener includes demographic information, psychiatric history, and current depression symptoms (self-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 (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 Childhood Trauma Questionnaire.

The Wechsler Abbreviated Scale for Intelligence-II (WASI-II), the Cambridge Neuropsychological Test Automated Battery (CANTAB), and computerized tasks described in the outcome measures will be administered by a study staff member.

Self-report questionnaires will be administered to the parents and adolescents assessing peer victimization, community violence exposure, child and family demographics, stressful life events, food security, neglectful behaviors, social and cognitive stimulation during early childhood, discrimination, pubertal development, sleep behaviors, depression symptoms, and parent-child relationship quality.

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

EXPERIMENTAL SKILL LEARNING AND ASSESSMENT Approximately one week following the baseline assessment (up to four weeks to allow for any scheduling difficulties) all participants will complete a 60-minute skill learning session. Prior to the experimental skills learning procedures, a study staff member will complete a brief (10-minute) interview with participants asking them to identify and describe a stressful event or interpersonal interaction from the past week. Participants will be asked to describe in detail how they coped with the event. Prompts will be given to elicit more detail when necessary. The purpose of the interview is to assess baseline cognitive restructuring skill use. After completing the interview, a trained study clinician will deliver the "Repairing Thoughts" skills module teaching cognitive restructuring from the "FIRST: Principal Based Approach to Evidence-based Psychotherapy" manual to the adolescent. The interview and the skills module may be audio and/or video recorded. Participants will be asked to practice their skill at home each day after the visit for the next week, and they will be sent an electronic daily survey to indicate whether they practiced.

Participants will be asked to complete a 90-minute, second session, one week later (up to three weeks to allow for any scheduling difficulties) to review the skill and practice in-vivo with the study clinician. After review and practice with the study clinician, a study staff member will meet with the adolescent participant to repeat the interview conducted during the first session.

As a part of this second skill learning session, a study staff member will introduce an in-vivo cognitive restructuring task to assess acquisition of the skill. Prior to the start of the in-vivo skill, resting-state continuous measurement of electrodermal activity (EDA; skin conductance), electrocardiogram (ECG), and respiration (RSP) will be collected at baseline. Study staff members (or the parent, if the adolescent prefers) will attach the electrodes and wireless transmitters (attached by velcro band to participants wrist and torso, on the exterior surface of clothing). After a baseline resting period, participants will be shown four brief film clips from movies or TV shows that have been extensively tested for reliably evoking negative emotions. Participants will be instructed to "watch" two clips, and to use cognitive restructuring to "reappraise" and reduce their emotional response during the remaining two clips (order counter-balanced). Continuous EDA, ECG, and RSP measurement will span the duration of the lab task and a three-minute recovery period that follows. The difference in physiological recovery between the "watch" and "reappraise" clips indexes cognitive restructuring ability.

Skill Retention Assessment. Participants will be sent online self-report surveys via the secure Qualtrics platform at 1-week, 3-months and 6-months follow-up. The interview conducted at pre- and post-skill learning sessions will also be repeated via phone at these timepoints. At 1-week follow-up, the online survey is a memory test for the cognitive restructuring skill. At 3-months follow-up and 6-months follow-up, self-report surveys will assess depression symptom levels, any psychotherapy or psychotropic medication services initiated since the last in-person visit, and the memory test for the cognitive restructuring skill. Adolescent participants will also re-complete the interview from the last in-person visit, conducted over the phone with study staff at all three follow-ups.

Eligibility criteria: Inclusion Criteria:

* Between the ages 12 years 0 months through 15 years 11 months at study enrollment
* Have clinically elevated depression symptom severity based a cut-off score of ≥ 7 on the Patient Health Questionnaire-9, verified by clinician ratings on the Depression Rating Scale.

Exclusion Criteria:

* Lifetime presence of a DSM-5 Psychotic or Autism Spectrum Disorder
* Lifetime presence of a neurological or serious medical condition
* Current DSM-5 diagnosis of substance abuse or dependence

Primary outcomes:
measure: Cognitive Restructuring Skill Acquisition
timeFrame: Immediately post-intervention
measure: Cognitive Restructuring Skill Retention up to 6-months
timeFrame: Pre-intervention up to 6-months follow-up
measure: Cognitive Restructuring Knowledge Test
timeFrame: Immediately post-intervention
measure: Biobehavioral sympathetic recovery
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: Biobehavioral parasympathetic regulation
timeFrame: Immediately post-intervention
Other outcomes:
measure: Self-reported depression symptom severity
timeFrame: Pre-intervention up to 6-months post-intervention
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Rachel A Vaughn-Coaxum, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weisz, J. R., & Bearman, S. K. (2020). Principle-Guided Psychotherapy for Children and Adolescents: The FIRST Program for Behavioral and Emotional Problems. Guilford Press.
citation: Gilman TL, Shaheen R, Nylocks KM, Halachoff D, Chapman J, Flynn JJ, Matt LM, Coifman KG. A film set for the elicitation of emotion in research: A comprehensive catalog derived from four decades of investigation. Behav Res Methods. 2017 Dec;49(6):2061-2082. doi: 10.3758/s13428-016-0842-x.