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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
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behavior Problem

Eligibility Criteria

2 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 30, 2019
    Last Updated
    September 13, 2021
    Sponsor
    Florida International University
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    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

    Learn more about this trial

    Evaluation of Intensive Parent-Child Interaction Therapy"

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