Activating and Connecting Teens (ACT) Study

Depression Clinical Trial

— ACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438656
• Other study ID #: STUDY00002283
• Secondary ID: K23MH112872
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

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.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH), Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	Anhedonia	Changes in feelings of loss of pleasure and interest (i.e., Anhedonia) will be measured via self-report.	Weeks 0, 12, and 24
Primary	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.
Primary	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.
Primary	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
Primary	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	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).
Secondary	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)
Secondary	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)
Secondary	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)