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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
Sponsor:
Collaborators:
Seattle Children's Hospital
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jessica Jenness, University of Washington

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).

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
Contact: Jessica L Jenness, MD 206 616-7967 jennessj@uw.edu

Locations
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Jessica Jenness, PhD    205-221-7456    actstudy@uw.edu   
Contact: Elizabeth McNeilly, MA    206-221-7456    actstudy@uw.edu   
Sponsors and Collaborators
University of Washington
Seattle Children's Hospital
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Jessica L Jenness, MD University of Washington

Responsible Party: Jessica Jenness, Acting Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03438656     History of Changes
Other Study ID Numbers: STUDY00002283
K23MH112872 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jessica Jenness, University of Washington:
Depression
Childhood adversity
Behavioral Activation
Reward Processing
fMRI

Additional relevant MeSH terms:
Depression
Behavioral Symptoms