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Behavioral Intervention

FIRST Psychotherapy for Youth Mental Health Issues

N/A

Recruiting

Research Sponsored by Harvard University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ages 7.0-15.9 years

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed throughout treatment via observational coding (ongoing from 0 up to 78 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of a new transdiagnostic treatment against usual care outpatient psychotherapy, for youths' mental health outcomes. The new treatment is based on five principles of change, and one proposed mechanism of change is regulation of negative emotions.

Who is the study for?

This trial is for children aged 7 to almost 16 who show signs of anxiety, depression, conduct issues, or post-traumatic stress but are generally in English-speaking classes. It's not for kids at immediate suicide risk, with eating disorders, schizophrenia-related conditions, autism spectrum disorder, intellectual disabilities needing special school classes or those referred only for ADHD symptoms.

What is being tested?

The study tests FIRST—a therapy based on five proven principles—against the usual care given to young people with mental health challenges. The focus is on how well each treatment improves mental health and helps manage negative emotions.

What are the potential side effects?

Since this trial involves psychotherapy rather than medication, side effects may include emotional discomfort during sessions and potential increases in distress as difficult topics are discussed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 7 and 15 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ monthly beginning after first session through end of treatment (every 4 weeks from 0 up to 78 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~monthly beginning after first session through end of treatment (every 4 weeks from 0 up to 78 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly beginning after first session through end of treatment (every 4 weeks from 0 up to 78 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

Secondary study objectives

Coping Questionnaire (CQ; Crane & Kendall, 2020)

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

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

+1 more

Other study objectives

Engagement of families in treatment

Evidence-Based Practice Attitudes Scale (EBPAS-15; Aarons, 2004)

Evidence-Based Treatment Intentions (EBTI; Williams, 2015)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FIRSTExperimental Treatment1 Intervention

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.

Group II: Usual CareActive Control1 Intervention

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

0 / 1Eligibility criteria met