Positive Affect Treatment for Adolescents With Early Life Adversity (PAT4ELA)

Mitigating Depression Among Adversity Exposed Adolescents Using Positive Affect Therapy

Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. The present project will test the efficacy of PAT in a sample of ELA-exposed adolescents in order to determine whether PAT increases positive affect, and subsequently symptoms of depression. For the initial pilot phase of the investigation, the investigators will recruit up to 30 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or a waitlist control condition. For the second phase of the investigation, the investigators will recruit up to 300 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or supportive psychotherapy. For both phases, at study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia and reward sensitivity). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: Positive affect treatment; Behavioral: Supportive psychotherapy (SUP)

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kate R Kuhlman, Ph.D.; Phone Number: 9498245574; Email: krkuhl@uci.edu

Study Locations

• United States
  • California
    • Irvine, California, United States, 92617
      • Recruiting
      • University of California Irvine
      • Contact: Kate R Kuhlman; Phone Number: 9498245574; Email: krkuhl@uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• aged 12-16
• exposed to 2 or more adverse childhood experiences (ACEs)

Exclusion Criteria:

• currently taking an antidepressant or any medications known to influence immune functioning on a daily basis (e.g., steroidal medications to treat asthma or allergies)
• current or past history of manic or psychotic symptoms
• parent-reported diagnosis of intellectual disability or autism spectrum disorder
• chronic medical conditions (e.g., cancer, rheumatoid arthritis, diabetes, multiple sclerosis),
• bleeding disorders such as hemophilia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist
Experimental: Positive affect treatment; PAT is a 15-week cognitive-behavioral therapy that focuses on increasing reward motivation and sensitivity at the neural, behavioral, and affective levels of analysis. These observed effects occur through PAT's effects on reward sensitivity and positive affect. Participants will be assigned to a therapist with training in cognitive-behavioral therapy who will meet with them weekly via telehealth.	Behavioral: Positive affect treatment; PAT includes 15 weekly, 1-hour sessions. The treatment is composed of three modules targeting behaviors (Sessions 1-7), cognitions (Sessions 8 -10), and compassion (Sessions 11-14), with skills being reinforced in a cumulative manner in subsequent sessions. The final session in the original treatment (Session 15) addressed relapse prevention, which will be adapted to focus on further reinforcing and generalizing learned skills. The treatment includes guided activities that target different aspects of positive affectivity such as reward approach-motivation, reward learning, and reward attainment.; Other Names: PAT
Active Comparator: Supportive Psychotherapy (SUP); Participants randomized to SUP will receive 15 weeks of SUP from a doctoral student in clinical psychology. SUP is a flexibly-delivered, manualized evidence-based treatment that focuses on reinforcing a patient's existing coping strategies while fostering a positive therapeutic relationship. Supportive psychotherapy provides a time, attention, and social support control that is similar to a placebo but likely to be perceived as relevant to this population.	Behavioral: Supportive psychotherapy (SUP); Supportive psychotherapy provides a time, attention, and social support control that is similar to a placebo but likely to be perceived as relevant to this population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
depressive symptoms - anhedonia subscale	Reynolds Adolescent Depression Scale 2nd Edition - anhedonia subscale score; Scores can range from 7-28 with higher values indicating more severe anhedonia.	4 months / end of treatment
Systemic inflammation - C-reactive protein (CRP)	C-reactive protein concentrations measured in saliva; assay detection range is approximately 25 pg/mL - 1600 pg/mL with higher values indicating the presence of more systemic inflammation.	4 months / end of treatment
reward sensitivity	Reward motivation will be assessed behaviorally with the Effort Expenditures for Reward Task (EEfRT). The EEfRT assesses reward sensitivity by compelling participants to choose to engage in high and low effort motor tasks for varying potential monetary gains and computes reward sensitivity as the difference in propensity to choose hard choice trials at increasing trial values.	4 months / end of treatment
8. Self-reported reward sensitivity	Self-reported reward sensitivity will be assessed using the 21-item Positive Valence System Scale (PVSS-21) which will be assessed at study enrollment, and then 4-, 8-, and 12-months after study enrollment. For each item, responses can range from 1-8, and the questionnaire is scored using a sum. Total scores can range from 21 - 189 and lower scores reflect a worse outcome.	4 months / end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory gene expression	Degree of expression of 19 pro-inflammatory genes as measured via genome-wide transcriptional profiling of RNA from peripheral blood mononuclear cells. Values are expressed as z-scores, and higher values indicate greater average expression of pro-inflammatory genes.	4 months / end of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive affect	Positive and negative affect Schedule (PANAS) - positive affect subscale score; scores can range from 10 to 50 with higher values indicating more positive affect.	4-months / end of treatment
depressive symptoms - total	Reynolds Adolescent Depression Scale 2nd Edition (RADS-2) - Total Score; Scores can range from 30-120 with higher values indicating more depressive symptoms.	4 months / end of treatment

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Kate R Kuhlman, UC Irvine

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2024
• Primary Completion (Estimated): October 31, 2030
• Study Completion (Estimated): October 31, 2030

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: 2963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No