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NCT Number: NCT06273137

Positive Affect Treatment for Adolescents With Early Life Adversity

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Irvine

Irvine, California, 92617, United States

Location status: Recruiting

Location contact

Kate R Kuhlman

CONTACT

[email protected]

9498245574

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive Affect Treatment

Behavioral

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

Supportive psychotherapy (SUP)

Behavioral

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.

Primary outcomes

  1. depressive symptoms - anhedonia subscale

    Time frame: 4 months / end of treatment

    Reynolds Adolescent Depression Scale 2nd Edition - anhedonia subscale score; Scores can range from 7-28 with higher values indicating more severe anhedonia.

  2. reward sensitivity

    Time frame: 4 months / end of treatment

    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.

  3. Systemic inflammation - C-reactive protein (CRP)

    Time frame: 4 months / end of treatment

    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. 8. Self-reported reward sensitivity

    Time frame: 4 months / end of treatment

    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.

Secondary outcomes

  1. Inflammatory gene expression

    Time frame: 4 months / end of treatment

    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.

Other outcomes

  1. Positive affect

    Time frame: 4-months / end of treatment

    Positive and negative affect Schedule (PANAS) - positive affect subscale score; scores can range from 10 to 50 with higher values indicating more positive affect.

  2. depressive symptoms - total

    Time frame: 4 months / end of treatment

    Reynolds Adolescent Depression Scale 2nd Edition (RADS-2) - Total Score; Scores can range from 30-120 with higher values indicating more depressive symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Kate R Kuhlman, Ph.D.

CONTACT

[email protected]

9498245574

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Mitigating Depression Among Adversity Exposed Adolescents Using Positive Affect Therapy

Acronym: PAT4ELA

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Feb 22, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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