NCT01732601

Brief Summary

This study will identify the effectiveness of an intensive treatment program for teens who are at high risk for harming themselves.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1 depression

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_1 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 26, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

5.1 years

First QC Date

November 13, 2012

Last Update Submit

January 21, 2018

Conditions

Keywords

Suicide AttemptSuicidal IdeationNSSISubstance Use

Outcome Measures

Primary Outcomes (1)

  • Suicide attempts

    Self-report by parents or teens of a suicide attempt occurring in the follow-up period

    Measured at 18 months from Baseline

Secondary Outcomes (1)

  • Depressed mood as assessed by the Children's Depression Rating Scale - Revised

    Measured at 18 months from Baseline

Other Outcomes (1)

  • Other self harm behaviors including Nonsuicidal self-injury (NSSI) substance abuse

    Measures 18 months from Baseline

Study Arms (2)

Intensive Outpatient CBT

EXPERIMENTAL

Intensive CBT for both parents and adolescents as well as family sessions to increase communication.

Behavioral: Intensive Outpatient CBT

Standard Care

ACTIVE COMPARATOR

Standard Treatment in the Community

Behavioral: Standard Care

Interventions

Sessions will be delivered 1-2 times a week for the first 4-6 weeks, based on need, and then weekly until 6 months. Therapy can continue up until one year.

Also known as: Intensive CBT for High Risk Teens with a mood disorder
Intensive Outpatient CBT
Standard CareBEHAVIORAL

Treatment at step-down facilities

Also known as: Treatment as Usual
Standard Care

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Current Mood Disorder and suicidal ideation and one of the following
  • NSSI
  • Suicide Attempt
  • Substance Use

You may not qualify if:

  • Intelligence Quotient \< 80
  • Diagnosis of psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, bulimia nervosa or anorexia nervosa
  • Adolescent use of illicit "hard" substances such as cocaine, heroine, and opiates 13 or more times over the prior 90 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

Related Publications (1)

  • Esposito-Smythers C, Wolff JC, Liu RT, Hunt JI, Adams L, Kim K, Frazier EA, Yen S, Dickstein DP, Spirito A. Family-focused cognitive behavioral treatment for depressed adolescents in suicidal crisis with co-occurring risk factors: a randomized trial. J Child Psychol Psychiatry. 2019 Oct;60(10):1133-1141. doi: 10.1111/jcpp.13095. Epub 2019 Jul 21.

MeSH Terms

Conditions

DepressionSuicideSuicide, AttemptedSuicidal IdeationSubstance-Related Disorders

Interventions

Standard of CareTherapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-Injurious BehaviorChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Anthony Spirito, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2012

First Posted

November 26, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2017

Study Completion

January 1, 2018

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations