Disorder of Speech and Language DevelopmentNCT04346069
Role Of Parent-Child Interaction Therapy Towards Management Of Language And Behavioral Problems Among Children
A study testing PCIT (parent child interaction therapy) in people with Disorder of Speech and Language Development, run by Isra University.
Trial summary
maltreatment are particularly vulnerable towards child abuse and developing mental and physical health issues. parent child interaction therapy (PCIT)) is one of those interventions which can address these vulnerabilities by improving parent to child relation and interaction, primarily improving parenting skills and… Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Disorder of Speech and Language Development
- What is being tested?
- PCIT (parent child interaction therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to May 2021
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants of the study age between 2to 7years however both the genders are included
- Referred cases for language delay, behavioral or attention/hyperactive problems
- ECBI score of greater than 120
- Parental consent to the study
- Biological Parents
- Minimum education: high school
- Willing to participate
Who cannot join
- Mental retardation or pervasive developmental disorder in the child.
- Should not be under any other kind of the therapeutical intervention .
- Psychosis or serious drug abuse in parents
- Lack of sufficient proficiency in parents to fill in the questionnaires
Trial locations and contacts
No sites are listed yet.
About this study
maltreatment are particularly vulnerable towards child abuse and developing mental and physical health issues.
parent child interaction therapy (PCIT)) is one of those interventions which can address these vulnerabilities by improving parent to child relation and interaction, primarily improving parenting skills and helping parents cope with their parenting stress and child's behavioral problems.
Read more
PCIT is empirically validated to decrease parenting stress, couple conflict and enhance parent child interaction, resulting in better coping skills while parenting for a child with disability.
This research is very vital as it measures the efficacy of parent child interaction.
In Pakistan mostly parents are bringing their children to clinic without any support from government therefore it is not possible for everyone to get daily based therapeutic intervention.
The area of Parent-child Interaction Therapy and the acceptance of these treatments are new and emerging in Pakistani Health Care, apart from above; this research will also assist in identifying further areas of research.
Read the detailed description
The objective of this study is to determine the efficacy of parent-based intervention in Pakistan.
Parent-Child Interaction Therapy PCIT in treating the behavior problem and language problem due to behavioral disturbances in young children more than usual treatments.
- To assess efficacy of PCIT intervention program.
- To translate the Eyeberg Child Behavior Inventory (ECBI), Child-Parent Relationship Scale, Child Behavior Checklist (CBCL) , Test of Early Language-3rd edition (TELD-3) and applications in Urdu language.
- To translate Child-Parent Relationship Scale and applications in Urdu language.
- To translate Child Behavior Checklist (CBCL) and applications in Urdu language.
- To translate Test of Early Language-3rd edition (TELD-3) and applications in Urdu language.
- To translate parenting relation questionnaire (PQR) in Urdu language.
- To translate parent stress index (PSI) in Urdu.
- To determine the reliability and validity of the Urdu translated interventional and assessment tools.
- To determine prior to and at the conclusion of the intervention performance on measures of parenting relation, parenting tress, children compliance.
- Being tested
- PCIT (parent child interaction therapy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIT (parent child interaction therapy)Other
Also called Regular speech therapy
Parent child interaction therapy is a treatment strategy that nurture parent child relationship and teach effective parenting strategies to decrease child non compliance behavior (BodifordMcNeil; Hembree-Kigin, 2010).Parent-Child Interaction Therapy (PCIT; Eyberg; Robinson, 1982 ; Zisser; Eyberg, 2008 ) is a manualized parent training intervention that has received substantial empirical support in the treatment of disruptive behavior across multiple reviews (e.g., Brestan; Eyberg, 1998 ; Gallagher, 2003 ; Thomas \& Zimmer-Gembeck, 2007 ). PCIT established strong relation among parenting, social learning, and attachment theories and proceeds.
| Study group | Role | What they receive |
|---|---|---|
| Regular speech therapy | Other | Regular speech therapy will be provided to the controlled group Receives: Other: PCIT (parent child interaction therapy) |
| Parent-child interaction therapy | Other | Parent child interaction therapy will be provided to the experimental group Receives: Other: PCIT (parent child interaction therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of parent chlid interaction therapy (PCIT)
parent child interaction therapy (PCIT)) is one of those interventions which can address these vulnerabilities by improving parent to child relation and interaction, primarily improving parenting skills and helping parents cope with their parenting stress and child's behavioral problems. efficacy will be assessed by the Parenting Stress Index - Short Form
Measured: 6 months
efficacy of parent chlid interaction therapy (PCIT) will be assessed by the Marital Status Inventory
Measured: 6 months
efficacy of parent chlid interaction therapy (PCIT) will be assessed by the Child-Parent Relationship Scale .
Measured: 6 months
efficacy of parent chlid interaction therapy (PCIT) will be assessed by the Eyeburg inventory.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study startJun 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Speech and Language DevelopmentStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahnaz, Isra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346069
- Sponsor's protocol ID
- IsraUP
- Status last verified
- Apr 2020
- First submitted
- 14 Mar 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Parent-Child Interaction Therapy Towards Management Of Language And Behavioral Problems Among Children
- ClinicalTrials.gov ID
- NCT04346069
- Acronym / sponsor ID
- IsraUP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 15 Apr 2020 (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.
maltreatment are particularly vulnerable towards child abuse and developing mental and physical health issues.
parent child interaction therapy (PCIT)) is one of those interventions which can address these vulnerabilities by improving parent to child relation and interaction, primarily improving parenting skills and helping parents cope with their parenting stress and child's behavioral problems.
PCIT is empirically validated to decrease parenting stress, couple conflict and enhance parent child interaction, resulting in better coping skills while parenting for a child with disability.
This research is very vital as it measures the efficacy of parent child interaction.
In Pakistan mostly parents are bringing their children to clinic without any support from government therefore it is not possible for everyone to get daily based therapeutic intervention.
The area of Parent-child Interaction Therapy and the acceptance of these treatments are new and emerging in Pakistani Health Care, apart from above; this research will also assist in identifying further areas of research.
Detailed description
The objective of this study is to determine the efficacy of parent-based intervention in Pakistan.
Parent-Child Interaction Therapy PCIT in treating the behavior problem and language problem due to behavioral disturbances in young children more than usual treatments.
- To assess efficacy of PCIT intervention program.
- To translate the Eyeberg Child Behavior Inventory (ECBI), Child-Parent Relationship Scale, Child Behavior Checklist (CBCL) , Test of Early Language-3rd edition (TELD-3) and applications in Urdu language.
- To translate Child-Parent Relationship Scale and applications in Urdu language.
- To translate Child Behavior Checklist (CBCL) and applications in Urdu language.
- To translate Test of Early Language-3rd edition (TELD-3) and applications in Urdu language.
- To translate parenting relation questionnaire (PQR) in Urdu language.
- To translate parent stress index (PSI) in Urdu.
- To determine the reliability and validity of the Urdu translated interventional and assessment tools.
- To determine prior to and at the conclusion of the intervention performance on measures of parenting relation, parenting tress, children compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular speech therapy | Other | Other: PCIT (parent child interaction therapy)Regular speech therapy will be provided to the controlled group |
| Parent-child interaction therapy | Other | Other: PCIT (parent child interaction therapy)Parent child interaction therapy will be provided to the experimental group |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Participants of the study age between 2to 7years however both the genders are included
- Referred cases for language delay, behavioral or attention/hyperactive problems
- ECBI score of greater than 120
- Parental consent to the study
- Biological Parents
Key exclusion criteria (4 listed)
- Mental retardation or pervasive developmental disorder in the child.
- Should not be under any other kind of the therapeutical intervention .
- Psychosis or serious drug abuse in parents
- Lack of sufficient proficiency in parents to fill in the questionnaires
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 |
|---|---|---|
| PCIT (parent child interaction therapy)Also: Regular speech therapyParent child interaction therapy is a treatment strategy that nurture parent child relationship and teach effective parenting strategies to decrease child non compliance behavior (BodifordMcNeil; Hembree-Kigin, 2010).Parent-Child Interaction Therapy (PCIT; Eyberg; Robinson, 1982 ; Zisser; Eyberg, 2008 ) is a manualized parent training intervention that has received substantial empirical support in the treatment of disruptive behavior across multiple reviews (e.g., Brestan; Eyberg, 1998 ; Gallagher, 2003 ; Thomas \& Zimmer-Gembeck, 2007 ). PCIT established strong relation among parenting, social learning, and attachment theories and proceeds. | Other | Parent-child interaction therapy, Regular speech therapy |
Primary outcome
efficacy of parent chlid interaction therapy (PCIT)
Time frame: 6 months
parent child interaction therapy (PCIT)) is one of those interventions which can address these vulnerabilities by improving parent to child relation and interaction, primarily improving parenting skills and helping parents cope with their parenting stress and child's behavioral problems. efficacy will be assessed by the Parenting Stress Index - Short Form
efficacy of parent chlid interaction therapy (PCIT) will be assessed by the Marital Status Inventory
Time frame: 6 months
efficacy of parent chlid interaction therapy (PCIT) will be assessed by the Child-Parent Relationship Scale .
Time frame: 6 months
efficacy of parent chlid interaction therapy (PCIT) will be assessed by the Eyeburg inventory.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PCIT (parent child interaction therapy) in people with Disorder of Speech and Language Development, run by Isra 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SHAHNAZ YOUSUF, PHD (03335245530, shahnazyousaf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of parent chlid interaction therapy (PCIT) (time frame: 6 months). The study lists 4 primary outcomes in all. 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 15 Apr 2020.