Activating and Connecting Teens (ACT) Study

Sponsor

University of Washington (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03438656

Collaborator

Seattle Children's Hospital (Other), National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Behavioral Activation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

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 :

Mar 1, 2018

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Jul 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Depression [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 [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 [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 [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) [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 [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

Anxiety [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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