- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04077112
Evaluation of Intensive Parent-Child Interaction Therapy" (IPCIT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: traditional PCIT
once a week parent training
|
Behavioral parent training program targeting parent-child relationship
|
EXPERIMENTAL: intensive PCIT
every day for two weeks parent training
|
Behavioral parent training program targeting parent-child relationship
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Parenting Skills
Time Frame: The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion
|
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
|
Change in 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
|
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.
|
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
Time Frame: The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion
|
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.
|
The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-16-0323-CR03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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