Activating and Connecting Teens (ACT) Study

NCT03438656 | Completed Results

• 2 other identifiers: STUDY00002283K23MH112872
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Depression

Keywords

Depression; Childhood adversity; Behavioral Activation; Reward Processing

Outcome Measures

Primary Outcomes (2)

• 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

Other Outcomes (5)

• Anxiety

  Symptoms will be measured at baseline, post-treatment, and 3-month follow-up.

• Behavioral Problems

  Pre- (Week 0) and post-treatment (Week 12)

• Hopelessness

  Pre- (Week 0) and post-treatment (Week 12)

Study Arms (1)

Behavioral Activation Arm

EXPERIMENTAL

See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation.

Behavioral: Behavioral Activation

Interventions

Behavioral Activation BEHAVIORAL

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.

Behavioral Activation Arm

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- current diagnosis of clinical depression (minor or major) will be recruited as study participants in the Behavioral Activation (BA) Group

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Seattle Children's Hospital: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Assistant Professor
• Organization: University of Washington

jennessj@uw.edu

414-331-4871

Study Officials

• Jessica L Jenness, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Assistant Professor

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 20, 2018
• Study Start: March 1, 2018
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 2, 2024
• Results First Posted: May 2, 2024

Record last verified: 2024-04

Locations

US (1)