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Completed

NCT Number: NCT03438656

Activating and Connecting Teens (ACT) Study

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Behavioral Activation

Behavioral

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.

Primary outcomes

  1. Depression

    Time frame: Week 12 (post-treatment)

    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.

  2. Anhedonia/Activation

    Time frame: Week 12

    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.

Other outcomes

  1. Anxiety

    Time frame: Symptoms will be measured at baseline, post-treatment, and 3-month follow-up.

    Changes in anxiety symptoms and diagnoses with diagnostic interviews and self-report (SCARED).

  2. Behavioral Problems

    Time frame: Pre- (Week 0) and post-treatment (Week 12)

    Changes in commonly co-morbid behavioral problems with depression (i.e., attention deficit/hyperactivity disorder, conduct problems, oppositionality) and diagnoses will be measured.

  3. Hopelessness

    Time frame: Pre- (Week 0) and post-treatment (Week 12)

    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.

  4. Suicidality

    Time frame: Weekly throughout treatment (Weeks 0-12) and at a 3-month follow-up (24 Week)

    Changes in suicidal ideation, plans, and behaviors and self-harm thoughts and behaviors will be measured on a semi-structured interview and self-report.

  5. Ecological Momentary Assessment (EMA)

    Time frame: Questionnaires delivered 3x/day, 2 days/week from Weeks 0 to 12

    Changes in self-reported activity engagement and mood will be delivered through a mobile application.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Seattle Children's Hospital

Registry information

Official study title

Targeted Intervention for Adolescents Following Child Maltreatment: Examining Neural and Behavioral Mechanisms Within the Positive Valence System

Acronym: ACT

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2018
Registry last updated
May 2, 2024

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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