Evaluation of Intensive Parent-Child Interaction Therapy" (IPCIT)
Primary Purpose
Behavior Problem, Parenting
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Parent Child Interaction Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Behavior Problem
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
traditional PCIT
intensive PCIT
Arm Description
once a week parent training
every day for two weeks parent training
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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 (α's .88-.94). Total score range from 36 to 180 with higher scores indicating greater levels of parenting stress.
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 (α's = .82-.88) and Over-Reactivity (α'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.
Full Information
NCT ID
NCT04077112
First Posted
August 30, 2019
Last Updated
September 13, 2021
Sponsor
Florida International University
1. Study Identification
Unique Protocol Identification Number
NCT04077112
Brief Title
Evaluation of Intensive Parent-Child Interaction Therapy"
Acronym
IPCIT
Official Title
Evaluation of Intensive Parent-Child Interaction Therapy"
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Problem, Parenting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
traditional PCIT
Arm Type
Active Comparator
Arm Description
once a week parent training
Arm Title
intensive PCIT
Arm Type
Experimental
Arm Description
every day for two weeks parent training
Intervention Type
Behavioral
Intervention Name(s)
Parent Child Interaction Therapy
Intervention Description
Behavioral parent training program targeting parent-child relationship
Primary Outcome Measure Information:
Title
Change in Externalizing Behavior Problems
Description
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.
Time Frame
The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion
Secondary Outcome Measure Information:
Title
Change in Parenting Skills
Description
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).
Time Frame
The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion
Title
Change in Parenting stress
Description
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 (α's .88-.94). Total score range from 36 to 180 with higher scores indicating greater levels of parenting stress.
Time Frame
The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion
Title
Change in Discipline Practices
Description
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 (α's = .82-.88) and Over-Reactivity (α'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.
Time Frame
The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
final data set will be available upon request
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Evaluation of Intensive Parent-Child Interaction Therapy"
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