NCT05613595

Brief Summary

The Central idea of the proposed research proposal is first to translate adapt and validate the Caregiver Difficulties Scale \& Positive Psychotherapy sessions based manual into Urdu language then secondly, assessment of burnout, burden, depression, mental wellbeing, sense of coherence and social support among caregivers of Cerebral palsy children and finally measuring the effectiveness of Positive Psychotherapy for treating mental health issues of caregivers of Cerebral Palsy children. This research proposal will provide an Urdu language based standardized positive psycho therapeutic based intervention to mental health practitioners for treating mental health issues of caregivers of cerebral palsy children in sociocultural context of Pakistan. In Pakistan earlier conducted researches mainly focused on assessment of mental health issues of caregivers of cerebral palsy children, however present research will not only assess the sample regarding their mental health issues, but in addition it will also contribute in provision of psychometrically sound Urdu language based positive Psychotherapy. Positive Psychotherapy focuses on positive emotions and personal strengths instead of ruminating over weaknesses.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration 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

November 11, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

October 28, 2022

Last Update Submit

November 4, 2022

Conditions

Keywords

Positive psychotherapySense of CoherenceSocial support

Outcome Measures

Primary Outcomes (6)

  • Change in Parental Burnout Assessment

    a 23- item self-report questionnaire for assessment of Burn Out

    baseline and 8th week

  • Change in Depression Anxiety Stress Scale

    DASS is a self-report 21 items based questionnaire designed to measure depression, anxiety and stress

    baseline and 8th week

  • Change in Caregiver Difficulties Scale

    a self-administered questionnaire measure the caregiver burden

    baseline and 8th week

  • Change in Sense of Coherence

    Measured by the orientation of life scale, It contains 13 items

    baseline and 8th week

  • Change in wellbeing Positive Psychotherapy Inventory

    self-report inventory having 25 items.it assess level of mental wellbeing,

    baseline and 8th week

  • Change Multidimensional Scale of Perceived Social Support

    Social support is measured across three domains; friends, family and significant others. The responses reflect participant's perception of support from each of these three sources

    baseline and 8th week

Study Arms (2)

Positive Psychotherapy Group

ACTIVE COMPARATOR

In this phase of the study, the caregivers of CP having moderate to high scores on mental health issues on three scales (Depression, Burnout \& Caregiver burden) will receive positive Psychotherapy sessions for a period of four months, divided over different weekly sessions. For Psychotherapy treatment group participants will be given both counseling as well as Positive psychotherapy based interventions. . Each session will be based upon individual session and duration of the session will be 40 minutes. Before starting every session feedback will be taken about the previous session and home based assignments will also be discussed

Behavioral: Positive Psychotherapy

Counseling Group

ACTIVE COMPARATOR

10 participants will be included in in control group (N=10), for control group caregivers will be given regular counseling as a part of treatment of their child (psychoeducation). Each session will be based upon individual session and duration of the session will be 40 minutes.

Behavioral: Counseling Group

Interventions

Positive Psychotherapy is an effective treatment for many mental disorders and depression is primary empirical target. Its primary goal is to build positive emotion, engagement, and meaning in life that will alleviate depression and other mental health disorders. Thus PPT may offer a new way to treat and prevent mental health issues. Interventions sessions included, Session Records Session One: Positive Introduction and Gratitude Journal Session Two: Character Strengths and Signature Strengths Session Three: Practical Wisdom , Session Four: A Better Version of Me , Session Five: Open and Closed Memories, Session Six: Forgiveness Session Seven: Maximizing versus Satisficing, Session Eight: Gratitude ,Session Nine: Hope and Optimism, Session Ten: Posttraumatic Growth, Session Eleven: Slowness and Savoring, Session Twelve: Positive Relationships, Session Thirteen: Positive Communication, Session Fourteen: Altruism , Session Fifteen: Meaning and Purpose

Positive Psychotherapy Group

Caregivers in control group only regular counseling will be provided (psychoeducation). it will be based upon the insight of cerebral palsy and training based on Adaptive skill functioning of the CP child of the caregivers

Counseling Group

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Only those participants will be included who would have moderate to high score on caregiver burden, depression \& burnout and lower score in wellbeing, social support \& sense of coherence.
  • Interventions will be given to the caregivers having moderate level of burnout \& depression.
  • Caregiver will be someone who takes the primary responsibility for caregiving a child with CP.
  • Only caregivers of Diagnosed CP child
  • Caregivers having only 1 CP child in the family
  • Educational status of the care giver will be matric and above.

You may not qualify if:

  • More than 1 CP child in the family
  • Caregivers who are Uneducated will not be added in the present study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Rehabilitation Medicine

Islamabad, Pakistan

RECRUITING

MeSH Terms

Conditions

Caregiver BurdenCerebral Palsy

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Rabia Mushtaq, PhD

    International Islamic University, Islamabad

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Present study will be conducted on caregivers of Cerebral palsy children. It will be conducted in four phases. In phase I, Urdu translation \& adaptation of Caregiver Difficulties Scale (CDS) and Positive Psychotherapy (PPT) manual will be done. .
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 28, 2022

First Posted

November 14, 2022

Study Start

November 11, 2021

Primary Completion

January 12, 2023

Study Completion

August 31, 2023

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations