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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04077112
Other study ID # IRB-16-0323-CR03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date May 2018

Study information

Verified date September 2021
Source Florida International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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). Using a randomized trial design, 60 young children (M child age = 4.33 years; range 2-6.92; 65% male; 85% Latinx) with elevated levels of EBP and their mothers were assigned to either I-PCIT (n = 30) or traditional PCIT (n = 30). Families completed pre-treatment and post-treatment assessments as well as a follow-up assessment 6-9 months following treatment completion. Across all assessments, mothers completed measures of child behavior, discipline practices, and parenting stress. Observational data on child behavior and parenting was also collected during three 5-minute standard situations that vary in the degree of parental control (child-led play, parent-led play, & clean-up).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 7 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Parent Child Interaction Therapy
Behavioral parent training program targeting parent-child relationship

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Florida International University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 (a'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 Change in Parenting Skills The Dyadic Parent-Child Interaction Coding System-4th Edition (DPICS-IV; Eyberg, Nelson, Ginn, Bhuiyan, & Boggs, 2013), an established behavioral coding system was used to measure the quality of parent-child interactions across all assessments. Consistent with prior PCIT research, we created a composite of do skills (behavior descriptions, reflections, praises) and don't skills (questions, commands, and negative talk) reflecting behaviors parents are taught during treatment to use and not use during a child-led play. Undergraduate student coders, who were masked to treatment status, were trained to 80% agreement with a criterion tape and coded 20% of the observations a second time to assess reliability. Reliability for the do (r's range from .87 to .94) and don't skills were excellent (r's .99). The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion
Secondary Change in Parenting stress Mothers completed the Parenting Stress Index-Short Form (PSI-SF; Abidin, 1983). The PSI-SF is a widely used 36-item self-report instrument for parents of children ages 1 month to 12 years measuring parental stress (Abidin, 1983). The PSI-SF total raw score was used to measure overall parenting stress (a's .88-.94). Total score range from 36 to 180 with higher scores indicating greater levels of parenting stress. The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion
Secondary Change in Discipline Practices Mothers completed the Parenting Scale (PS; Arnold, O'Leary, Wolff, & Acker, 1993), a 30-item self-report measure that assesses parental discipline practices of children as young as 18 months. The effectiveness of discipline techniques is measured based on three factor scores (Laxness, Over-Reactivity, Verbosity). The Laxness (a's = .82-.88) and Over-Reactivity (a's = .67-.83) scales were used to assess parenting practices. Due to poor reliability of the Verbosity scale (.33-.70), this scale was removed from all analyses. The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion
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