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: April 2024
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• 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:

• 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
Other	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.
Other	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)
Other	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)
Other	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	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
Primary	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)
Primary	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