AzTrials
AzTrials

AnxietyNCT04725721

Testing FIRST in Youth Outpatient Psychotherapy

A study testing FIRST in people with Anxiety and Depression, run by Harvard University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The study will compare the impact FIRST (a transdiagnostic treatment built upon five empirically supported principles of change) versus usual care outpatient psychotherapy on youths' mental health outcomes and a candidate mechanism of change: regulation of negative emotions. Read more about this study

Who is it for?
Ages 7 to 15 years
Conditions the study is for
Anxiety, Depression, Trauma
What is being tested?
FIRST
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
2 sitesUnited States
Study dates
27 Sep 2021to Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • ages 7.0-15.9 years
  • at least one clinically-relevant CBCL subscale score indicating borderline/clinical-range anxiety, depression, conduct problems, or post-traumatic stress
  • English fluency indicated by taking all school classes in English

Who cannot join

  • current suicide risk, operationalized as active suicidal ideation or a history of suicide attempt or inpatient hospitalization for suicide risk within the last 3 months
  • presence of an eating disorder, schizophrenia spectrum disorder, autism spectrum disorder, or intellectual disability requiring special class placement in school
  • referral for ADHD if specifically and exclusively to address inattentiveness and/or hyperactivity-impulsivity

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Texas at Austin

    Austin, Texas, 78712

  • Harvard University

    Cambridge, Massachusetts, 02138

Other trials in United States

About this study

The study will compare the impact FIRST (a transdiagnostic treatment built upon five empirically supported principles of change) versus usual care outpatient psychotherapy on youths' mental health outcomes and a candidate mechanism of change: regulation of negative emotions.

Read the detailed description

Children and adolescents (herein "youths") treated in outpatient mental health care span a broad range of problems and disorders, with substantial comorbidity, and their most pressing problems and treatment needs may shift during treatment. These challenges may be addressed by treatment that is flexible and transdiagnostic (i.e., applicable to multiple mental health problems and disorders). A recent transdiagnostic treatment, FIRST, created in collaboration with community practitioners and intervention scientists, uses a principle-based approach to support efficient learning and implementation by clinicians. FIRST is built upon five empirically supported principles of change (e.g., calming, problem solving), each applicable to treatment of depression, anxiety/OCD, trauma, and misconduct. Three open benchmarking trials of FIRST, using low-cost clinician training and group consultation, have shown steep slopes of clinical improvement in youths treated in outpatient clinics.

This randomized controlled effectiveness trial will provide a more definitive test of FIRST, an initial investigation of a candidate mechanism of change, and tests of therapist characteristics that may predict and moderate implementation of evidence-based practices. The sample will be ethnically and economically diverse youths, ages 7-15, from four community clinics-two in greater Boston MA, two in greater Austin TX-all referred by their families and all showing elevated depression, anxiety/OCD, post-traumatic stress, or conduct problems. Clinicians within each clinic will be randomly assigned to learn and use FIRST or to employ Usual Care (UC), and youths will be randomized to FIRST or UC. Clinical outcomes will include change on standardized measures of mental health and on severity of the specific problems identified as most important by each youth and each caregiver at baseline. Study measures will include a proposed mechanism-regulation of negative emotions- thought to be responsive to treatment and responsible for changes in mental health. Analyses will assess whether treatment with FIRST impacts regulation, and whether improved regulation accounts for outcomes of FIRST treatment relative to UC. Finally, the study will investigate whether clinicians' baseline knowledge of, attitudes toward, and motivation to use evidence-based practices predicts or moderates their implementation of such practices in psychotherapy. The study will thus provide the first randomized trial of this new practice-adapted transdiagnostic treatment, plus an inquiry into the process through which it may work and therapist factors that may strengthen or weaken implementation.

Being tested
FIRST, Usual Care
Keywords
anxiety, depression, trauma, behavior problems, youth, mental health, emotion regulation
Medical subject headings
Anxiety Disorders, Depression, Wounds and Injuries, Mental Disorders, Psychological Well-Being, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FIRSTBehavioural

    FIRST is built upon five empirically supported principles of change (ESPCs-i.e., feeling calm, increasing motivation, repairing thoughts, solving problems, trying the opposite). Each principle can be applied to treatment of problems spanning depression, anxiety (including OCD and PTS), and conduct problems-thus encompassing a majority of the youths seen in outpatient care. Its design addresses breadth of problem coverage, youth comorbidity, and flux in youth treatment needs during episodes of care. It is used in conjunction with performance feedback via a web-based tracking system that gives clinicians weekly data on youth treatment response. FIRST has treatment and training efficiency, and efficient clinician skill-building is supported by group consultation.

  • Usual CareBehavioural

    Treatment in the usual care (UC) condition will use the clinical procedures therapists consider appropriate and believe to be effective.

Study groups in NCT04725721
Study groupRoleWhat they receive
FIRSTExperimentalFIRST is built upon five empirically supported principles of change (ESPCs-i.e., feeling calm, increasing motivation, repairing thoughts, solving problems, trying the opposite). Each principle can be applied to treatment of problems spanning depression, anxiety (including OCD and PTS), and conduct problems-thus encompassing a majority of the youths seen in outpatient care. Its design addresses breadth of problem coverage, youth comorbidity, and flux in youth treatment needs during episodes of care. It is used in conjunction with performance feedback via a web-based tracking system that gives clinicians weekly data on youth treatment response. FIRST has treatment and training efficiency, and efficient clinician skill-building is supported by group consultation.
Receives: Behavioral: FIRST
Usual CareActive comparatorTreatment in the usual care (UC) condition will use the clinical procedures therapists consider appropriate and believe to be effective.
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2001) and Youth Self-Report (YSR; Achenbach & Rescorla, 2001)

    The CBCL is a parent-report checklist with 113 youth problem items, each rated on a 0-1-2 scale (0 = not true, 1 = somewhat/sometimes true, 2 = very often true). The YSR is a corresponding 112-item youth-report checklist measure. From both the CBCL and the YSR, T-scores, adjusted for age and gender, Internalizing, Externalizing, and Total Problems scales will be used for outcome assessment. Higher scores represent more severe problems, with borderline and clinical cutoffs at T = 60 and T = 63, respectively. Evidence of CBCL/YSR validity and reliability is strong and extensive.

    Measured: Change from baseline to 18 months (quarterly at 0, 3, 6, 9, 12, and 18 months from 0 up to 78 weeks)

  2. Behavior and Feelings Survey (BFS; Weisz et al., 2020)

    The 12-item BFS is a measure of internalizing (6 items), externalizing (6 items), and total problems, developed via four studies, three with samples of clinically referred youths aged 7-15 and their caregivers. Both youth and caregiver forms showed robust factor structure, internal consistency, test-retest reliability, convergent and discriminant validity in relation to three well-established symptom measures (including CBCL and YSR), and slopes of change indicating efficacy in monitoring treatment progress during therapy. Items are rated on a scale from 0 (not a problem) to 4 (a very big problem). Internalizing and externalizing scale scores range from 0 to 24 and total problems from 0 to 48 (with higher scores indicating greater problem severity).

    Measured: Change from baseline through end of treatment (weekly from 0 up to 78 weeks)

  3. Functional Top Problems Assessment (TPA; Weisz et al., 2011)

    The TPA assesses youth and caregiver severity ratings (from 0 = not a problem to 4 = a very big problem) for the functional top three problems the youth and caregiver independently identified as most important to them, in separate baseline interviews. Psychometric analyses have shown strong test-retest reliability, convergent and discriminant validity for the TPA in relation to standardized measures, and sensitivity to change during treatment.

    Measured: Change from baseline through end of treatment (weekly from 0 up to 78 weeks)

Secondary outcomes (4)

  1. Positive and Negative Affect Schedule Short Form (PANAS-C/P-SF; Laurent et al., 1999; Ebesutani et al., 2011)

    Derived from the original Positive and Negative Affect Schedule, the brief 10-item PANAS includes 5 adjectives for positive affect (joyful, cheerful, happy, lively, proud) and 5 for negative affect (miserable, mad, afraid, scared, sad), on which youth and their parents report the extent to which they felt each on a 5- point Likert scale from 1 (very slightly or not at all) to 5 (extremely). Evidence of convergent and divergent validity of both the positive and negative affect scale scores with reports of anxiety and depressive symptoms has been found as well as good internal consistency of both scales. The 10-item version has shown similar validity and reliability properties and superior measurement properties as compared to the 27-item version. Total positive and negative affect scale scores range from 5 to 25, such that higher scores reflect stronger endorsement of positive or negative mood states.

    Measured: Change from baseline through end of treatment (weekly from 0 up to 78 weeks)

  2. Coping Questionnaire (CQ; Crane & Kendall, 2020)

    The CQ was developed in the context of the youth anxiety treatment research to assess youth and caregiver ratings of the youths' ability to regulate the emotional arousal associated with anxiety disorders. The CQ procedure is both idiographic (each youth and each caregiver identifies three situations that make the youth most upset) and standardized (each youth and each caregiver then rates, for each situation, the youth's ability "to make yourself (or himself/herself) feel less upset" on a 1 to 7 Likert scale). This simple measure, tested with a sample of 442 7-17 year-olds, showed good evidence of internal consistency, convergent and divergent validity in relation to measures of psychopathology and functioning, and criterion validity in its association with clinical severity ratings of the youths' principle diagnosis on a standardized diagnostic interview.

    Measured: Change from baseline through end of treatment (weekly from 0 up to 78 weeks)

  3. Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID parent version; Sheehan et al., 2010)

    The parent version of the MINI-KID is a structured diagnostic interview for DSM-IV and ICD-10 youth psychiatric disorders. It has been shown to provide efficient and highly reliable and valid diagnoses.

    Measured: Change from baseline (0 months) to end of treatment (up to 78 weeks)

  4. UCLA PTSD Reaction Index (PTSDRI; Steinberg et al., 2004)

    The PTSDRI has been widely used to assess PTS symptoms in children and teens. Various studies have shown good evidence of internal consistency, test-retest reliability, and validity relative to both degree of exposure to traumas and to PTSD diagnoses on standardized interviews.

    Measured: Baseline for entire sample; quarterly (3, 6, 9, 12, and 18 months) for up to 18 months for those with elevated baseline PTS symptoms (from 0 up to 78 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2021
  2. Study start27 Sep 2021
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04725721
Sponsor's protocol ID
IRB20-1875
Status last verified
Apr 2026
First submitted
10 Jan 2021
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data will be uploaded to the NIMH Data Archive (NDA).

Publications

  • Cho E, Bearman SK, Woo R, Weisz JR, Hawley KM. A Second and Third Look at FIRST: Testing Adaptations of A Principle-Guided Youth Psychotherapy. J Clin Child Adolesc Psychol. 2021 Nov-Dec;50(6):919-932. doi: 10.1080/15374416.2020.1796678. Epub 2020 Aug 7.

    PubMed 32762554

  • Weisz J, Bearman SK, Santucci LC, Jensen-Doss A. Initial Test of a Principle-Guided Approach to Transdiagnostic Psychotherapy With Children and Adolescents. J Clin Child Adolesc Psychol. 2017 Jan-Feb;46(1):44-58. doi: 10.1080/15374416.2016.1163708. Epub 2016 Jul 21.

    PubMed 27442352

  • Weisz JR, Vaughn-Coaxum RA, Evans SC, Thomassin K, Hersh J, Ng MY, Lau N, Lee EH, Raftery-Helmer JN, Mair P. Efficient Monitoring of Treatment Response during Youth Psychotherapy: The Behavior and Feelings Survey. J Clin Child Adolesc Psychol. 2020 Nov-Dec;49(6):737-751. doi: 10.1080/15374416.2018.1547973. Epub 2019 Jan 18.

    PubMed 30657721

  • Weisz JR, Chorpita BF, Frye A, Ng MY, Lau N, Bearman SK, Ugueto AM, Langer DA, Hoagwood KE; Research Network on Youth Mental Health. Youth Top Problems: using idiographic, consumer-guided assessment to identify treatment needs and to track change during psychotherapy. J Consult Clin Psychol. 2011 Jun;79(3):369-80. doi: 10.1037/a0023307.

    PubMed 21500888

  • Laurent J, Catanzaro SJ, Joiner TE, Rudolph KD, Potter KI, Lambert S, Osborne L, Gathright T. A measure of positive and negative affect for children: Scale development and preliminary validation. Psychological Assessment. 1999; 11(3): 326-338.

  • Ebesutani C, Okamura K, Higa-McMillan C, Chorpita BF. A psychometric analysis of the Positive and Negative Affect Schedule for Children-Parent Version in a school sample. Psychol Assess. 2011 Jun;23(2):406-16. doi: 10.1037/a0022057.

    PubMed 21381834

  • Daughters SB, Reynolds EK, MacPherson L, Kahler CW, Danielson CK, Zvolensky M, Lejuez CW. Distress tolerance and early adolescent externalizing and internalizing symptoms: the moderating role of gender and ethnicity. Behav Res Ther. 2009 Mar;47(3):198-205. doi: 10.1016/j.brat.2008.12.001. Epub 2008 Dec 13.

    PubMed 19135649

  • Crane ME, Kendall PC. Psychometric Evaluation of the Child and Parent Versions of the Coping Questionnaire. Child Psychiatry Hum Dev. 2020 Oct;51(5):709-720. doi: 10.1007/s10578-020-00975-w.

    PubMed 32157488

  • Aarons GA. Mental health provider attitudes toward adoption of evidence-based practice: the Evidence-Based Practice Attitude Scale (EBPAS). Ment Health Serv Res. 2004 Jun;6(2):61-74. doi: 10.1023/b:mhsr.0000024351.12294.65.

    PubMed 15224451

  • Steinberg AM, Brymer MJ, Decker KB, Pynoos RS. The University of California at Los Angeles Post-traumatic Stress Disorder Reaction Index. Curr Psychiatry Rep. 2004 Apr;6(2):96-100. doi: 10.1007/s11920-004-0048-2.

    PubMed 15038911

  • Williams NJ. Assessing mental health clinicians' intentions to adopt evidence-based treatments: reliability and validity testing of the evidence-based treatment intentions scale. Implement Sci. 2016 May 5;11:60. doi: 10.1186/s13012-016-0417-3.

    PubMed 27150798

  • Shirk SR, Karver MS, Brown R. The alliance in child and adolescent psychotherapy. Psychotherapy (Chic). 2011 Mar;48(1):17-24. doi: 10.1037/a0022181.

    PubMed 21401270

  • McLeod BD, Weisz JR. The therapy process observational coding system-alliance scale: measure characteristics and prediction of outcome in usual clinical practice. J Consult Clin Psychol. 2005 Apr;73(2):323-33. doi: 10.1037/0022-006X.73.2.323.

    PubMed 15796640

  • Lawson GM, Moore TM, Okamura KH, Becker-Haimes EM, Beidas RS. Knowledge of Evidence-Based Services Questionnaire: Development and Validation of a Short Form. Adm Policy Ment Health. 2020 Jul;47(4):581-596. doi: 10.1007/s10488-020-01020-7.

    PubMed 32076887

  • Chorpita BF, Park A, Tsai K, Korathu-Larson P, Higa-McMillan CK, Nakamura BJ, Weisz JR, Krull J; Research Network on Youth Mental Health. Balancing effectiveness with responsiveness: Therapist satisfaction across different treatment designs in the Child STEPs randomized effectiveness trial. J Consult Clin Psychol. 2015 Aug;83(4):709-18. doi: 10.1037/a0039301. Epub 2015 May 18.

    PubMed 25984802

Questions about this trial

What is this clinical trial studying?

A study testing FIRST in people with Anxiety and Depression, run by Harvard University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2001) and Youth Self-Report (YSR; Achenbach & Rescorla, 2001) (time frame: Change from baseline to 18 months (quarterly at 0, 3, 6, 9, 12, and 18 months from 0 up to 78 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04725721, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in