Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04719897
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2021-01-18
Brief Title:
Life Experiences in Adolescents and the Development of Skills
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Effects of Stressful Life Experiences on the Acquisition of a Coping Skill in Adolescents With Elevated Depression Symptoms
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEADS
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 Childrens 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-PL 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-PL 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 andor 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
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-PL 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-PL 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23MH123685-01 | NIH | None | httpsreporternihgovquickSearch1K23MH123685-01 |