NCT06087302

Brief Summary

Exposure to trauma during childhood contributes to behavioral and attachment difficulties in children. The current research study will be conducted on the effectiveness of child-parent relationship therapy (CPRT) on psychological distress and family functioning among parents of children exposed to trauma. The CPRT is an evidence-based intervention parenting program that gives training to the parents, to help children who have social, emotional, attachment, and behavioral difficulties. A CPRT would train parents with the principles of CCPT and provide them with the ability to support their children. A randomized controlled trial will validate the effect of CPRT on family functioning, and parental psychological distress among parents of children exposed to trauma. It will be an interventional-based study on CPRT with a pre-posttest experimental design. The current study would be conducted in Islamabad and Rawalpindi, after obtaining permission from the appropriate authorities, for collecting data from the educated mothers/caretakers as a research sample. There would be inclusive and exclusive selection criteria for the sample. A study will be conducted in four ways, firstly, the need assessment will be conducted with phenomenological research design from selected educated mothers/caretakers on the KAP model (knowledge, attitudes, and practices) categories about the CPRT, and psychological distress on family functioning among parents of children exposed to trauma. In phase two, the pilot study will be conducted to assess the accuracy of measures for the sample and the effectiveness of CPRT. In phase three, a cross-sectional survey would measure the study variables. The fourth phase will be the intervention phase for validation of CPRT therapeutic techniques in the Pakistani population a randomized controlled trial design will be applied to analyze the effect of CPRT on study variables in the next phase (main study). The measures Child-Parent Relationship Scale, depression, anxiety, and stress scale, family assessment device, and disruptive behavior through Children's Behavior Questionnaire (very short form) parental-version will be used to collection the data from study participants. The Child and Adolescent Trauma Screen would be used as a screening inventory. The CPRT intervention therapeutic sessions will continue based on the inclusive and exclusive selection criteria. The data will be evaluated through SPSS (latest version).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 23, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2024

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

October 3, 2023

Last Update Submit

January 25, 2024

Conditions

Keywords

Child Parent relationship therapyFamily functioning,Psychological distresschild exposed to Traumadisruptive behavior

Outcome Measures

Primary Outcomes (3)

  • Child Parent Relationship Scale

    it consists of fifteen items about the child and the parent's relationship with it. Likert weighed the fifteen items on a 5-point scale, and CPRS can be summarized by groups of objects that most closely correspond to the discrepancy and closeness.

    10-15 minutes

  • Depression Anxiety Stress Scale-42

    it is based on measurements rather than categorical concepts of mental distress, and scores emphasize symptoms are experienced, not diagnostic thresholds. it has been unable to use a child's scale for 12 years, The three symptom clusters are as follows: Depression: Illegal problems, despair, life assessment, vertical, pride, interest/involvement, and tribe/involvement, Anxiety: Herbal arousal, skeletal muscle effects, conditional warnings, fear of anxiety. Stress: Chronic non-special Here, the complexity is comfortable, nervous, easily frustrated/excited, sensitive/impatient beyond.

    5-10 minutes

  • Family Assessment Device

    measures structural, organizational, and transactional factors within families. A total of six scales are used to measure the six dimensions of the MMFF - affective involvement, affective responsiveness, behavioral control, communication, problem solving, and roles - as well as a seventh measure measuring general family functioning

    10-15 minutes

Secondary Outcomes (1)

  • Child and adolescent Behavior Inventory

    5-10 minutes

Other Outcomes (1)

  • Child and Adolescent Trauma Screen-Caregiver

    5-10 minutes

Study Arms (2)

control group

NO INTERVENTION

the control group wouldnot receive the CPRT for caregivers/parents

CPRT intervention group

EXPERIMENTAL

intervention group would receive the CPRT for caregivers/parents

Behavioral: child-Parent Relationship Therapy (CPRT)

Interventions

The Child Parent Relationship Therapy (CPRT) is an evidence-based intervention program that trains parents/caretakers to help their children with social, emotional, attachment, and behavioral difficulties

CPRT intervention group

Eligibility Criteria

Age20 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsmothers of children between 3-10 years would be part of the study
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • qualification would be graduation minimum and above
  • location: from Pakistan's twin cities (Rawalpindi and Islamabad). 3. the parents of children exposed to traumatic experiences
  • child abuse (physical abuse, yelling, Psychological Abuse)
  • bullying, (witness of bullying, verbal bullying, physical bullying)
  • fighting, (street fighting. witness of fighting)
  • traumatized grief, (death of a loved one)
  • Robbery and
  • parents' separation.

You may not qualify if:

  • uneducated parents, (less then graduation)
  • domestic violence
  • child sexual abuse,
  • natural disasters,
  • traumatic events that caused physical disabilities,
  • war,
  • terrorism victims, and
  • families who would be taking any psychotherapy or training to manage psychological distress and child disruptive behavior.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tayyaba Hanif

Rawalpindi, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Child Behavior DisordersProblem Behavior

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersBehavioral SymptomsBehaviorChild Behavior

Central Study Contacts

tayyaba hanif, Ph.D Schloar

CONTACT

DR Iram Gul, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
there would be two groups intervention group and a control group.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Child-Parent Relationship Therapy (CPRT) is a play-established therapy process for young children, aged between 3-10, who have attachment issues, and behavioral, social, or emotional issues. It is based on ten weekly, two-hour group sessions for a group of 5-8 members in the group. Learning skills, receiving feedback on skill practice, and connecting with other parents for support are all critical components of the CPRT program. Parents learn skills and prepare for future play sessions with their children during sessions 1-3. Parents practice their new skills with their children in weeks 4-10, while the therapist provides feedback in a small group setting.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. scholar

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 17, 2023

Study Start

May 23, 2023

Primary Completion

December 31, 2023

Study Completion

March 9, 2024

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations