Activating and Connecting Teens (ACT) Study

Study Overview
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Brief Summary
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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).

Official Title
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Targeted Intervention for Adolescents Following Child Maltreatment: Examining Neural and Behavioral Mechanisms Within the Positive Valence System

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Behavioral Activation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Activation Arm<br>See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation. | Behavioral: Behavioral Activation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Changes in depression symptoms and diagnoses will be measured with diagnostic interviews and self-report. | 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). | 
| Anhedonia | Changes in feelings of loss of pleasure and interest (i.e., Anhedonia) will be measured via self-report. | Weeks 0, 12, and 24 | 
| 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. | MRI scans will occur at Weeks 0 (pre-treatment) and Weeks 12 (post-treatment) of the study. | 
| 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. | MRI scans will occur at Weeks 0 (pre-treatment) and Weeks 12 (post-treatment) of the study. | 
| Ecological Momentary Assessment (EMA) | Changes in self-reported activity engagement and mood will be delivered through a mobile application. | Questionnaires develiered 3x/day, 2 days/week from Weeks 0 to 12 | 
| 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). | Weeks 0 through 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Changes in anxiety symptoms and diagnoses with diagnostic interviews and self-report. | 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). | 
| 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. | Pre- (Week 0) and post-treatment (Week 12) | 
| 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. | Pre- (Week 0) and post-treatment (Week 12) | 
| 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. | Weekly throughout treatment (Weeks 0-12) and at a 3-month follow-up (24 Week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Childhood adversity, Behavioral Activation, Reward Processing, fMRI