Activating and Connecting Teens (ACT) Study (ACT)

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

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 proposal will examine whether BA intervention reduces depression and anhedonia in a sample of depressed adolescents, aged 13-18, with variable histories of CM exposure (BA Group). A total of 30 depressed adolescents will be recruited to undergo a 12-week course of BA. All participants will undergo clinical assessment to measure depression symptoms and anhedonia at baseline (Week 0) and post- (Week 12) treatment.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Behavioral Activation

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria Behavioral Activation Group:

- 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Changes in depression symptoms will be measured with self-report on the Patient Health Questionnaire-9 (PHQ-9). Total score will be reported with a range of 0 to 27 with higher scores indicating greater symptoms of depression. Higher symptoms of depression are considered a worse outcome.	Week 12 (post-treatment)
Anhedonia/Activation	Changes in feelings of loss of pleasure and interest (i.e., Anhedonia) will be measured via self-report on the Behavioral Activation for Depression Scale (BADS) total score. The range on the BADS is 0 to 150, with higher scores representing less activation. Higher scores are considered a worse outcome on this measure.	Week 12

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Anxiety	Changes in anxiety symptoms and diagnoses with diagnostic interviews and self-report (SCARED).	Symptoms will be measured at baseline, post-treatment, and 3-month follow-up.
Ecological Momentary Assessment (EMA)	Changes in self-reported activity engagement and mood will be delivered through a mobile application.	Questionnaires delivered 3x/day, 2 days/week from Weeks 0 to 12

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH); Seattle Children's Hospital
• Investigators: Principal Investigator: Jessica L Jenness, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Behavioral Activation; Reward Processing; Childhood adversity
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: STUDY00002283; K23MH112872 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No