Activating and Connecting Teens (ACT) Study (ACT)
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|ClinicalTrials.gov Identifier: NCT03438656|
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Behavioral Activation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeted Intervention for Adolescents Following Child Maltreatment: Examining Neural and Behavioral Mechanisms Within the Positive Valence System|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||October 1, 2021|
Experimental: Behavioral Activation Arm
See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation.
Behavioral: Behavioral Activation
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.
- Depression [ 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). ]Changes in depression symptoms and diagnoses will be measured with diagnostic interviews and self-report.
- Anhedonia [ Time Frame: Weeks 0, 12, and 24 ]Changes in feelings of loss of pleasure and interest (i.e., Anhedonia) will be measured via self-report.
- Neural Reward Sensitivity [ Time Frame: MRI scans will occur at Weeks 0 (pre-treatment) and Weeks 12 (post-treatment) of the study. ]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 [ Time Frame: MRI scans will occur at Weeks 0 (pre-treatment) and Weeks 12 (post-treatment) of the study. ]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) [ Time Frame: Questionnaires develiered 3x/day, 2 days/week from Weeks 0 to 12 ]Changes in self-reported activity engagement and mood will be delivered through a mobile application.
- Behavioral Activation-Passive [ Time Frame: Weeks 0 through 24 ]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).
- Anxiety [ 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). ]Changes in anxiety symptoms and diagnoses with diagnostic interviews and self-report.
- Behavioral Problems [ Time Frame: Pre- (Week 0) and post-treatment (Week 12) ]Changes in commonly co-morbid behavioral problems with depression (i.e., attention deficit/hyperactivity disorder, conduct problems, oppositionality) and diagnoses will be measured.
- Hopelessness [ Time Frame: Pre- (Week 0) and post-treatment (Week 12) ]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 [ Time Frame: Weekly throughout treatment (Weeks 0-12) and at a 3-month follow-up (24 Week) ]Changes in suicidal ideation, plans, and behaviors and self-harm thoughts and behaviors will be measured on a semi-structured interview and self-report.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438656
|Contact: Jessica L Jenness, MD||206 firstname.lastname@example.org|
|United States, Washington|
|Seattle Children's Hospital||Recruiting|
|Seattle, Washington, United States, 98105|
|Contact: Jessica Jenness, PhD 205-221-7456 email@example.com|
|Contact: Elizabeth McNeilly, MA 206-221-7456 firstname.lastname@example.org|
|Principal Investigator:||Jessica L Jenness, MD||University of Washington|