Targeted Intervention for Adolescents Following Child Maltreatment: Examining Neural and Behavioral Mechanisms Within the Positive Valence System
Phase: NA
Conditions: Depression
Sponsor: University of Washington

 
 
Activating and Connecting Teens (ACT) Study 
 
NCT03438656 
 
03/01/2021 
 

ACT Study Protocol and Statistical Analysis Plan 
Childhood maltreatment is common1,2 and has been linked to a multitude of negative outcomes, including 
psychiatric and functional impairments that persist across the lifespan.2–4 Exposure to physical, sexual, or 
emotional abuse or neglect is associated with markedly elevated risk for depression5 with epidemiological 
studies indicating that these forms of childhood maltreatment (CM) account for as much as 30% of depression 
onsets in the population2,6 and predict a more chronic and severe course of depression.7 Currently cognitive 
behavioral therapy and antidepressant medication is recommended as best practice for treatment of 
depression.8 However, depressed individuals who have experienced CM show poor treatment response and 
high risk for relapse across interventions,7,9–11 and alternative treatments have not been investigated. 
 
A history of CM exposure may increase risk for depression via altered neurodevelopment of the positive 
valence system (i.e., reward processing).12 Given the reward processing deficits observed among depressed 
youth with a history of CM exposure, depression outcomes may be improved by investigating interventions that 
specifically target disruptions in reward circuitry and behaviors. 
 
Behavioral Activation (BA) is an evidence-based treatment for adult and adolescent depression13–15 that uses 
an individualized approach to identify and foster behaviors within an adolescent’s context that increase 
rewarding experiences and decrease avoidant behaviors that contribute to depression symptom severity and 
maintenance. This is the first study to investigate BA as an alternative, target-focused approach to treat 
depression among adolescents with a history of CM exposure.  
 
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. 
  
Participant Table 
Inclusion Criteria 
Exclusion Criteria 
BA Group n=30 
 
1) Age 13-18; 2) major or minor 
depression (PHQ ≥10).  
1) IQ<80; 2) non-English speaking; 3) current 
PTSD; 4) developmental, neurological, psychosis, 
bipolar, or substance disorder; 5) No legal 
guardian; 6) current psychiatric medication; 7) 
suicidality requiring higher level of care. 
 
 
Study Aims: 
Aim 1: Determine baseline and post-BA treatment depression and anhedonia symptoms among depressed 
adolescents with variable histories of CM. 
 
Exploratory Aim: Evaluate whether changes in self-reported anhedonia or other indicators of reward 
processing as measured by daily ecological momentary assessment and self-report are differentially 
associated with reductions in depression following BA in youth with versus without CM exposure. 
 
Data Analyses: Across all analyses: primary outcomes will be measured as 1) depression and anhedonia 
symptoms. Aim 1. Determine baseline and post-BA treatment depression and anhedonia symptoms 
among depressed adolescents with variable histories of CM. Means and standard deviations in 
depression (PHQ-9) and anhedonia symptoms (BADS) will be measured at baseline and post-treatment follow-
up. 
 
Exploratory aim. Evaluate whether changes in self-reported anhedonia or other indicators of reward 
processing are differentially associated with reductions in depression following BA in youth with versus without 
CM exposure. Participants completed morning, afternoon, and evening EMA surveys twice a week over 14 
weeks (n= 84 timepoints). Measures assessed depression symptoms, CM exposure, and reward 
processing/responsiveness across BA treatment. Using the lavaan package in R8, we plan to conduct Latent 
Growth Modeling (LGM) to test the associations between changes in reward processing and depression 
symptoms with CM as a fixed moderator. Covariates will include age, sex, and socioeconomic status.  

References 
1. 
Green JG, McLaughlin KA, Berglund PA, et al. Childhood adversities and adult psychiatric disorders in 
the national comorbidity survey replication I: associations with first onset of DSM-IV disorders. Arch Gen 
Psychiatry. 2010;67(2):113-123. 
2. 
McLaughlin KA, Green JG, Gruber MJ, Sampson NA, Zaslavsky AM, Kessler RC. Childhood adversities 
and first onset of psychiatric disorders in a national sample of US adolescents. Arch Gen Psychiatry. 
2012;69(11):1151-1160. 
3. 
McLaughlin KA, Green JG, Gruber MJ, Sampson NA, Zaslavsky AM, Kessler RC. Childhood adversities 
and adult psychiatric disorders in the national comorbidity survey replication II: associations with 
persistence of DSM-IV disorders. Arch Gen Psychiatry. 2010;67(2):124-132. 
4. 
McLaughlin KA, Green JG, Gruber MJ, Sampson NA, Zaslavsky AM, Kessler RC. Childhood adversities 
and adult psychopathology in the National Comorbidity Survey Replication (NCS-R) III: associations with 
functional impairment related to DSM-IV disorders. Psychol Med. 2010;40(05):847-859. 
5. 
Kessler RC. The effects of stressful life events on depression. Annu Rev Psychol. 1997;48:191-214. 
doi:10.1146/annurev.psych.48.1.191 
6. 
Afifi TO, Boman J, Fleisher W, Sareen J. The relationship between child abuse, parental divorce, and 
lifetime mental disorders and suicidality in a nationally representative adult sample. Child Abuse Negl. 
2009;33(3):139-147. 
7. 
Nanni V, Uher R, Danese A. Childhood Maltreatment Predicts Unfavorable Course of Illness and 
Treatment Outcome in Depression: A Meta-Analysis. Am J Psychiatry. 2012;169(2):141-151. 
doi:10.1176/appi.ajp.2011.11020335 
8. 
Birmaher B, Brent D. Practice Parameter for the Assessment and Treatment of Children and Adolescents 
With Depressive Disorders. J Am Acad Child Adolesc Psychiatry. 2007;46(11):1503-1526. 
doi:10.1097/chi.0b013e318145ae1c 
9. 
Lewis CC, Simons AD, Nguyen LJ, et al. Impact of childhood trauma on treatment outcome in the 
Treatment for Adolescents with Depression Study (TADS). J Am Acad Child Adolesc Psychiatry. 
2010;49(2):132-140. 
10. Brent DA, Emslie GJ, Clarke GN, et al. Predictors of spontaneous and systematically assessed suicidal 
adverse events in the treatment of SSRI-resistant depression in adolescents (TORDIA) study. Am J 
Psychiatry. 2009;166(4):418-426. 
11. Shamseddeen W, Asarnow JR, Clarke G, et al. Impact of physical and sexual abuse on treatment 
response in the Treatment of Resistant Depression in Adolescent Study (TORDIA). J Am Acad Child 
Adolesc Psychiatry. 2011;50(3):293-301. 
12. Dillon DG, Holmes AJ, Birk JL, Brooks N, Lyons-Ruth K, Pizzagalli DA. Childhood adversity is associated 
with left basal ganglia dysfunction during reward anticipation in adulthood. Biol Psychiatry. 
2009;66(3):206-213. 
13. Richardson L, McCauley E, Katon W. Collaborative care for adolescent depression: a pilot study. Gen 
Hosp Psychiatry. 2009;31(1):36-45. doi:10.1016/j.genhosppsych.2008.09.019 
14. Cuijpers P, van Straten A, Warmerdam L. Behavioral activation treatments of depression: A meta-
analysis. Clin Psychol Rev. 2007;27(3):318-326. doi:10.1016/j.cpr.2006.11.001 
15. McCauley E, Gudmundsen G, Schloredt K, et al. The Adolescent Behavioral Activation Program: 
Adapting Behavioral Activation as a Treatment for Depression in Adolescence. J Clin Child Adolesc 
Psychol. Published online 2015. doi:10.1080/15374416.2014.979933