Behavior ProblemIPCITNCT04077112
Evaluation of Intensive Parent-Child Interaction Therapy"
A study testing Parent Child Interaction Therapy in people with Behavior Problem and Parenting, run by Florida International University.
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… Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior Problem, Parenting
- What is being tested?
- Parent Child Interaction Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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).
Read the 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).
- Conditions
- Behavior Problem, Parenting
- Being tested
- Parent Child Interaction Therapy
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Child Interaction TherapyBehavioural
Behavioral parent training program targeting parent-child relationship
| Study group | Role | What they receive |
|---|---|---|
| traditional PCIT | Active comparator | once a week parent training Receives: Behavioral: Parent Child Interaction Therapy |
| intensive PCIT | Experimental | every day for two weeks parent training Receives: Behavioral: Parent Child Interaction Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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).
Measured: 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
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.
Measured: 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
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.
Measured: The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study startAug 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077112
- Sponsor's protocol ID
- IRB-16-0323-CR03
- Acronym
- IPCIT
- Status last verified
- Sep 2021
- First submitted
- 30 Aug 2019
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: final data set will be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intensive Parent-Child Interaction Therapy"
- ClinicalTrials.gov ID
- NCT04077112
- Acronym / sponsor ID
- IPCIT / IRB-16-0323-CR03
- Conditions
- Behavior Problem, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional PCIT | Active comparator | Behavioral: Parent Child Interaction Therapyonce a week parent training |
| intensive PCIT | Experimental | Behavioral: Parent Child Interaction Therapyevery day for two weeks parent training |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent Child Interaction TherapyBehavioral parent training program targeting parent-child relationship | Behavioural | intensive PCIT, traditional PCIT |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No. final data set will be available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Child Interaction Therapy in people with Behavior Problem and Parenting, run by Florida International University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.