NCT01517867

Brief Summary

The purpose of this study is to compare the effectiveness of two parenting programs in a mental health clinic serving young children with behavior problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

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, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
7 months until next milestone

Results Posted

Study results publicly available

April 2, 2018

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

5.4 years

First QC Date

January 23, 2012

Results QC Date

February 27, 2018

Last Update Submit

April 3, 2018

Conditions

Behavior Problems, Child

Keywords

preschool children behavior problemschild between 2 and 5 years old

Outcome Measures

Primary Outcomes (1)

  • Change in Child Behavior Problems

    parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child.

    baseline, first follow-up (up to 2 years)

Secondary Outcomes (1)

  • Aggregate Cost

    through end of study (up to 2 years)

Study Arms (2)

Intervention Chicago Parent Program arm

EXPERIMENTAL

The Chicago Parent Program is a 12-session group-based parenting skills training program

Behavioral: Chicago Parent Program

Parent-Child Interaction Therapy

ACTIVE COMPARATOR

Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems

Behavioral: Parent-Child Interaction Therapy

Interventions

Chicago Parent ProgramBEHAVIORAL

The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems

Intervention Chicago Parent Program arm
Parent-Child Interaction TherapyBEHAVIORAL

Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems

Parent-Child Interaction Therapy

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • child 2 to 5 years old
  • parent reports reason for referral is child behavior problems
  • parent is a biological or adoptive parent, or legal guardian of child

You may not qualify if:

  • parent is psychotic or actively abusing substances
  • child is autistic or severely developmentally delayed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Family Center at Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

  • Gross D, Belcher HME, Budhathoki C, Ofonedu ME, Dutrow D, Uveges MK, Slade E. Reducing Preschool Behavior Problems in an Urban Mental Health Clinic: A Pragmatic, Non-Inferiority Trial. J Am Acad Child Adolesc Psychiatry. 2019 Jun;58(6):572-581.e1. doi: 10.1016/j.jaac.2018.08.013. Epub 2018 Nov 12.

    PMID: 30768419DERIVED

  • Gross DA, Belcher HM, Ofonedu ME, Breitenstein S, Frick KD, Chakra B. Study protocol for a comparative effectiveness trial of two parent training programs in a fee-for-service mental health clinic: can we improve mental health services to low-income families? Trials. 2014 Mar 1;15:70. doi: 10.1186/1745-6215-15-70.

    PMID: 24581245DERIVED

MeSH Terms

Conditions

Mental Disorders

Results Point of Contact

Title
Deborah Gross
Organization
Johns Hopkins University
debgross@jhu.edu
410-614-5311

Study Officials

  • Deborah Gross, DNSc

    Johns Hopkins University, School of Nursing

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2012

First Posted

January 25, 2012

Study Start

September 1, 2011

Primary Completion

February 1, 2017

Study Completion

September 1, 2017

Last Updated

May 3, 2018

Results First Posted

April 2, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

No data sharing plan was developed.

Locations

US(1)