Clinical trial NCT03438656: Activating and Connecting Teens (ACT) Study
Official title: Targeted Intervention for Adolescents Following Child Maltreatment: Examining Neural and Behavioral Mechanisms Within the Positive Valence System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Childhood adversity
Behavioral Activation
Reward Processing
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
name: National Institute of Mental Health (NIMH)
First posted: 2018-02-20
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Depression
timeFrame: Week 12 (post-treatment)
measure: Anhedonia/Activation
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
measure: Anxiety
timeFrame: Symptoms will be measured at baseline, post-treatment, and 3-month follow-up.
measure: Behavioral Problems
timeFrame: Pre- (Week 0) and post-treatment (Week 12)
measure: Hopelessness
timeFrame: Pre- (Week 0) and post-treatment (Week 12)
measure: Suicidality
timeFrame: Weekly throughout treatment (Weeks 0-12) and at a 3-month follow-up (24 Week)
measure: Ecological Momentary Assessment (EMA)
timeFrame: Questionnaires delivered 3x/day, 2 days/week from Weeks 0 to 12
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: University of Washington
name: Jessica L Jenness, MD
role: PRINCIPAL_INVESTIGATOR
References: