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Activating and Connecting Teens (ACT) Study (ACT)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Childhood adversity, Behavioral Activation, Reward Processing, fMRI

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Behavioral Activation Group:

  • history of exposure to childhood adversity (e.g., abuse, neglect, violent victimization)
  • current diagnosis of clinical depression (minor or major) will be recruited as study participants in the Behavioral Activation (BA) Group

Exclusion Criteria:

  • IQ < 80;
  • non-English speaking youth or parent;
  • current PTSD diagnosis;
  • lifetime history of a developmental (e.g., autism), neurological (e.g., epilepsy), psychotic, bipolar, or substance disorder;
  • current psychiatric (e.g., antidepressants) or other mood altering medication (e.g., steroids) other than AD/HD medication;
  • requiring a higher level of care (i.e., inpatient hospitalization) due to suicidality or other mental or physical health related problem.
  • Any youths who are currently being maltreated will not be enrolled to ensure that participants do not have active safety concerns.
  • Full course of other evidence-based depression intervention

Sites / Locations

  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behavioral Activation Arm

Arm Description

See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation.

Outcomes

Primary Outcome Measures

Depression
Changes in depression symptoms and diagnoses will be measured with diagnostic interviews and self-report.
Anhedonia
Changes in feelings of loss of pleasure and interest (i.e., Anhedonia) will be measured via self-report.
Neural Reward Sensitivity
Changes in reward sensitivity will be measured by the Monetary Incentive Delay (MID) task completed while undergoing structural and functional MRI. The MID also provides behavioral indicators of reward sensitivity, including reaction time and accuracy to high versus low reward/neutral/loss values.
Neural Response to Social Feedback
The participants will complete a task in the MRI that measures social anhedonia. Participants will rate photos of peers on level of likeability and will receive either positive (i.e., they found the participant as likeable) or neutral (i.e., the peer has not rated the participant). Structural and functional MRI changes will be examined related to differences in response to positive social feedback.
Ecological Momentary Assessment (EMA)
Changes in self-reported activity engagement and mood will be delivered through a mobile application.
Behavioral Activation-Passive
Changes in activity engagement will be measured through passive mobile monitoring (i.e., mobile applications that track number of steps, calls, texts, and social media usage).

Secondary Outcome Measures

Anxiety
Changes in anxiety symptoms and diagnoses with diagnostic interviews and self-report.
Behavioral Problems
Changes in commonly co-morbid behavioral problems with depression (i.e., attention deficit/hyperactivity disorder, conduct problems, oppositionality) and diagnoses will be measured.
Hopelessness
Changes in feelings of hopelessness (i.e., feeling like nothing is good, everything is bad, nothing can change it) will be measured by self-report.
Suicidality
Changes in suicidal ideation, plans, and behaviors and self-harm thoughts and behaviors will be measured on a semi-structured interview and self-report.

Full Information

First Posted
February 5, 2018
Last Updated
May 16, 2023
Sponsor
University of Washington
Collaborators
Seattle Children's Hospital, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03438656
Brief Title
Activating and Connecting Teens (ACT) Study
Acronym
ACT
Official Title
Targeted Intervention for Adolescents Following Child Maltreatment: Examining Neural and Behavioral Mechanisms Within the Positive Valence System
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Seattle Children's Hospital, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
National data indicate over 650,000 children and adolescents are exposed to physical, sexual, or emotional abuse or physical or emotional neglect each year. Moreover, youth with a history of childhood maltreatment (CM) are at least twice as likely to develop depression and are at substantial risk for nonresponse to current best practice depression interventions (i.e., cognitive behavioral therapy and antidepressants) compared to non-maltreated peers. Research suggests that CM increases risk for depression through disruptions in the positive valence system, such as reward processing, and Behavioral Activation (BA) may be an alternative depression intervention that targets these deficits. This study takes an innovative approach integrating neural, behavioral, and novel mobile technologies to measure longitudinal change in reward processing as a mechanism of BA intervention response among depressed adolescents with a history of CM. Specifically, depressed adolescents with a history of CM will complete pre- and post- BA intervention fMRI and behavioral measures of reward processing along with daily passive mobile monitoring of physical (steps) and social (amount of texts, calls, social media usage) activity to determine 1) how BA targets neural and behavioral reward processing and real-world behavioral engagement (Specific Aim 1), and 2) whether change in neural and behavioral reward processing predicts intervention response and maintenance (Specific Aim 2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Childhood adversity, Behavioral Activation, Reward Processing, fMRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Activation Arm
Arm Type
Experimental
Arm Description
See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation
Intervention Description
The Adolescent Behavioral Activation Program (ABAP) will be used as the BA protocol. ABAP was developed and validated by McCauley, Dimidjian et al. to adapt BA to adolescents. ABAP is a 12-week protocol that utilizes an idiographic approach to foster rewarding experiences, effective problem solving, and goal attainment, and decrease avoidance, barriers to activation, and depressive rumination that may be contributing to depression severity and maintenance.
Primary Outcome Measure Information:
Title
Depression
Description
Changes in depression symptoms and diagnoses will be measured with diagnostic interviews and self-report.
Time Frame
Symptoms will be measured weekly throughout the study (Weeks 1-12) and at a 3-month follow-up (Week 24). Diagnoses will be measure pre (Week 0), post treatment (Week 12), and at a 3-month follow-up (Week 24).
Title
Anhedonia
Description
Changes in feelings of loss of pleasure and interest (i.e., Anhedonia) will be measured via self-report.
Time Frame
Weeks 0, 12, and 24
Title
Neural Reward Sensitivity
Description
Changes in reward sensitivity will be measured by the Monetary Incentive Delay (MID) task completed while undergoing structural and functional MRI. The MID also provides behavioral indicators of reward sensitivity, including reaction time and accuracy to high versus low reward/neutral/loss values.
Time Frame
MRI scans will occur at Weeks 0 (pre-treatment) and Weeks 12 (post-treatment) of the study.
Title
Neural Response to Social Feedback
Description
The participants will complete a task in the MRI that measures social anhedonia. Participants will rate photos of peers on level of likeability and will receive either positive (i.e., they found the participant as likeable) or neutral (i.e., the peer has not rated the participant). Structural and functional MRI changes will be examined related to differences in response to positive social feedback.
Time Frame
MRI scans will occur at Weeks 0 (pre-treatment) and Weeks 12 (post-treatment) of the study.
Title
Ecological Momentary Assessment (EMA)
Description
Changes in self-reported activity engagement and mood will be delivered through a mobile application.
Time Frame
Questionnaires develiered 3x/day, 2 days/week from Weeks 0 to 12
Title
Behavioral Activation-Passive
Description
Changes in activity engagement will be measured through passive mobile monitoring (i.e., mobile applications that track number of steps, calls, texts, and social media usage).
Time Frame
Weeks 0 through 24
Secondary Outcome Measure Information:
Title
Anxiety
Description
Changes in anxiety symptoms and diagnoses with diagnostic interviews and self-report.
Time Frame
Symptoms will be measured weekly throughout the study (Weeks 0 to 12) and at a 3-month follow-up (Week 24). Diagnoses will be measure pre (Week 0), post treatment (Week 12), and at a 3-month follow-up (Week 24).
Title
Behavioral Problems
Description
Changes in commonly co-morbid behavioral problems with depression (i.e., attention deficit/hyperactivity disorder, conduct problems, oppositionality) and diagnoses will be measured.
Time Frame
Pre- (Week 0) and post-treatment (Week 12)
Title
Hopelessness
Description
Changes in feelings of hopelessness (i.e., feeling like nothing is good, everything is bad, nothing can change it) will be measured by self-report.
Time Frame
Pre- (Week 0) and post-treatment (Week 12)
Title
Suicidality
Description
Changes in suicidal ideation, plans, and behaviors and self-harm thoughts and behaviors will be measured on a semi-structured interview and self-report.
Time Frame
Weekly throughout treatment (Weeks 0-12) and at a 3-month follow-up (24 Week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Behavioral Activation Group: history of exposure to childhood adversity (e.g., abuse, neglect, violent victimization) current diagnosis of clinical depression (minor or major) will be recruited as study participants in the Behavioral Activation (BA) Group Exclusion Criteria: IQ < 80; non-English speaking youth or parent; current PTSD diagnosis; lifetime history of a developmental (e.g., autism), neurological (e.g., epilepsy), psychotic, bipolar, or substance disorder; current psychiatric (e.g., antidepressants) or other mood altering medication (e.g., steroids) other than AD/HD medication; requiring a higher level of care (i.e., inpatient hospitalization) due to suicidality or other mental or physical health related problem. Any youths who are currently being maltreated will not be enrolled to ensure that participants do not have active safety concerns. Full course of other evidence-based depression intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica L Jenness, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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Activating and Connecting Teens (ACT) Study

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