NCT04077112

Brief Summary

The purpose to the current study was to examine the comparative efficacy of a more condensed intensive version of Parent-Child Interaction Therapy (I-PCIT; 5 days/week over the course of 2 weeks) versus a more traditional weekly PCIT format (1 day/week over the course of 10 weeks) in treating early childhood externalizing behavior problems (EBP).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

1.7 years

First QC Date

August 30, 2019

Last Update Submit

September 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Externalizing Behavior Problems

    Mothers completed the Eyberg Child Behavior Inventory (ECBI; Eyberg \& Ross, 1978), a 36-item questionnaire that is designed to assess the presence of externalizing problems in children ages 2 through 16 years. The total intensity scale t-score was used in the current study as the main measure of EBP (α's .84-.93). The total raw score ranged from 36 to 252. Higher scores indicate the presence of more externalizing behavior problems.

    The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion

Secondary Outcomes (3)

  • Change in Parenting Skills

    The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion

  • Change in Parenting stress

    The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion

  • Change in Discipline Practices

    The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion

Study Arms (2)

traditional PCIT

ACTIVE COMPARATOR

once a week parent training

Behavioral: Parent Child Interaction Therapy

intensive PCIT

EXPERIMENTAL

every day for two weeks parent training

Behavioral: Parent Child Interaction Therapy

Interventions

Behavioral parent training program targeting parent-child relationship

intensive PCITtraditional PCIT

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children had to be between 2 and 7 years of age
  • mothers had to rate their children above the clinically significant range (T-score \> 60) on a measure of child EBP (Eyberg Child Behavior Inventory; Eyberg \& Pincus, 1999),
  • be willing to come to treatment every day (Monday - Friday) during a two-week period,
  • both mother and child had to be able to speak and understand English.

You may not qualify if:

  • An intellectual disability (full scale IQ \< 70 based on the WPPSI-IV; Wechsler, 2012),
  • A previous Autism Spectrum Disorder diagnosis,
  • The inability of parents to attend sessions daily.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mental Disorders

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

August 30, 2019

First Posted

September 4, 2019

Study Start

August 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

September 20, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

final data set will be available upon request