NCT01159041

Brief Summary

This study is designed to compare two treatments for depression in pre-adolescent (7-13 year old) children. A family-focused treatment will be compared to an individual child-focused treatment in this 14-week intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable depression

Geographic Reach
1 country

2 active sites

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

January 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

5.3 years

First QC Date

July 7, 2010

Last Update Submit

January 22, 2018

Conditions

Keywords

Depression, children, adolescent, family

Outcome Measures

Primary Outcomes (1)

  • Adequate Depression Treatment Response

    50% improvement on Children's Depression Rating Scale-Revised

    3 months

Secondary Outcomes (2)

  • Interviewer-rated Depression Severity

    3 Months

  • Children's Self-Report of Depression Symptoms

    3 Months

Study Arms (2)

Family Focused Treatment (FFT)

EXPERIMENTAL

15 session family-based treatment emphasizing improving relationship skills to combat depression symptoms and support recovery.

Behavioral: Family Focused Treatment (FFT)

Individual Treatment (IP)

ACTIVE COMPARATOR

15 session individually-based treatment to assist children in understanding the causes of their symptoms.

Behavioral: Individual Treatment (IP)

Interventions

FFT is designed to specifically address the developmental needs of school-aged children and their parents through an emphasis on fostering positive and supportive parent-child interactions that scaffold the development of a positive self, to help parents provide the child additional positive feedback on his/her developmentally appropriate achievements, and to enhance family and child coping. This treatment is conducted with the child and his/her parent(s) and includes education about depression, communication training, relationship enhancement, and problem-solving.

Family Focused Treatment (FFT)

The goals of the treatment are to foster the therapeutic relationship, to provide a supportive and empathic setting where the child can come to better understand his/her emotions/feelings and address issues underlying current symptoms. Therapeutic goals will be addressed through reflection and clarification of feelings/emotions and understanding the child's perception of the context of depressed feelings.

Individual Treatment (IP)

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • current Depressive Disorder
  • ages 7-13 years
  • living with at least one biological parent willing to participate

You may not qualify if:

  • thought disturbance
  • severe conduct disorders
  • unstable on antidepressant medications
  • continuation in current non-study treatment
  • non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA Semel Institute for Neuroscience and Human Behavior

Los Angeles, California, 90095, United States

Location

Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (5)

  • Tompson MC, Pierre CB, Haber FM, Fogler JM, Groff AR, Asarnow JR. Family-focused treatment for childhood-onset depressive disorders: results of an open trial. Clin Child Psychol Psychiatry. 2007 Jul;12(3):403-20. doi: 10.1177/1359104507078474.

    PMID: 17953128BACKGROUND
  • Tompson MC, Boger KD, Asarnow JR. Enhancing the developmental appropriateness of treatment for depression in youth: integrating the family in treatment. Child Adolesc Psychiatr Clin N Am. 2012 Apr;21(2):345-84. doi: 10.1016/j.chc.2012.01.003. Epub 2012 Mar 17.

  • Tompson MC, Sugar CA, Langer DA, Asarnow JR. A Randomized Clinical Trial Comparing Family-Focused Treatment and Individual Supportive Therapy for Depression in Childhood and Early Adolescence. J Am Acad Child Adolesc Psychiatry. 2017 Jun;56(6):515-523. doi: 10.1016/j.jaac.2017.03.018. Epub 2017 Apr 7.

  • Tompson MC, Langer DA, Hughes JL, Asarnow JR. Family-Focused Treatment for Childhood Depression: Model and Case Illustrations. Cogn Behav Pract. 2017 Aug;24(3):269-287. doi: 10.1016/j.cbpra.2016.06.003.

  • Asarnow JR, Tompson MC, Klomhaus AM, Babeva K, Langer DA, Sugar CA. Randomized controlled trial of family-focused treatment for child depression compared to individual psychotherapy: one-year outcomes. J Child Psychol Psychiatry. 2020 Jun;61(6):662-671. doi: 10.1111/jcpp.13162. Epub 2019 Dec 15.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 7, 2010

First Posted

July 9, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2015

Study Completion

December 31, 2016

Last Updated

January 24, 2018

Record last verified: 2018-01

Locations