NCT04346069

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

March 14, 2020

Last Update Submit

April 14, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

    6 months

  • efficacy of parent chlid interaction therapy (PCIT) will be assessed by the Marital Status Inventory

    6 months

  • efficacy of parent chlid interaction therapy (PCIT) will be assessed by the Child-Parent Relationship Scale .

    6 months

  • efficacy of parent chlid interaction therapy (PCIT) will be assessed by the Eyeburg inventory.

    6 months

Study Arms (2)

Regular speech therapy

OTHER

Regular speech therapy will be provided to the controlled group

Other: PCIT (parent child interaction therapy)

Parent-child interaction therapy

OTHER

Parent child interaction therapy will be provided to the experimental group

Other: PCIT (parent child interaction therapy)

Interventions

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.

Also known as: Regular speech therapy
Parent-child interaction therapyRegular speech therapy

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

SHAHNAZ YOUSUF, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 14, 2020

First Posted

April 15, 2020

Study Start

June 1, 2020

Primary Completion

December 1, 2020

Study Completion

May 1, 2021

Last Updated

April 15, 2020

Record last verified: 2020-04