Psychological Functioning of Children and Adolescents With CHD andTheir Parents, An Intervention Based Study (CHDPIM)

March 9, 2022 updated by: Asma Riaz Hamdani, Government College University Faisalabad

Psychological Functioning of Children & Adolescent With Congenital Heart Disease, and Their Parents: An Intervention Based Study

Almost 1% of infants are born with Congenital Heart Disease (CHD), an umbrella term referring to a range of anomalies in the heart's structure that are present at birth. Owing to significant medical advances, it is now estimated that more than 90% of persons born with CHD will reach adulthood. Children with CHD and their families' mental health outcomes need for psychosocial care. This study will intend to improve the psychological functioning of children, adolescents with CHD and their parents. The research will comprise of two major studies. The sample of first study will be based on a Cohort (From April 2021 to October 2021) of children, adolescent and their parents. Participants will be assessed for their psychological functioning and health related quality of life using Strength and Difficulty Questionnaire, pedsQL 3.0 cardiac module , Parental Stress Index , and 36-Item Short Form Survey. It is hypothesized that parental psychological functioning will mediate the relationship between psychological functioning of children and adolescent with CHD and their health related quality of life. It is also hypothesized that emotional behavioral issues of children and adolescents will moderate the link between parental psychological functioning and their quality of life. Illness parameters and sociodemographic correlates will serve as covariates in the study. This study will provide a baseline for the second study that is expected to use a randomized control trial of an intervention program based on training workshops derived from CHIP for the reduction in parental distress, emotional behavioral problem and improvement in health related quality of life among children, adolescent with CHD and their parents. The pretest-posttest design will be used. The randomized control trial will be conducted as per Consort Guidelines. A sub sample will be selected from the initial study using purposive sampling. Intervention study will include a subsample of CHD population (60 children and adolescents each) and their parents using purposive sampling technique. The participants will be randomly assigned to experimental & control groups. Illness related and demographic parameters will be distributed equally in both groups for establishing control. The intervention will be administered to experimental group only, while control group will receive regular treatment. Results of Pretest and posttest measures will be statistically analyzed. The designed intervention program (using problem solving therapy, psycho-education and Parenting the child with CHD training) will lower the level of parental stress in parents and emotional behavioral issues in CHD population. It will further increase the level of health related quality of life among children and adolescent with CHD and their parents. The research will incorporate psychosocial care with CHD population along with their regular treatment and thus improve their future health related outcomes in Pakistan.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The approved clinical trial is a part of PhD research project entitled as ,"Psychological Functioning of Children and Adolescents with congenital Heart Disease, and Their Parents: An Intervention based study ". The study aims to assess the psychological functioning of CHD population in early years of life and evaluating its outcomes on their parents psychological health. Furthermore the clinical trials have designed to check the efficacy and utility of an Intervention Program for improving the quality of parenting and health related quality of life in children and adolescent with congenital heart disease.

The Randomized Control Trials will be used to check the utility of this intervention program. The intervention is derived from CHIP school, CHIP family and psychological intervention for CHD patients Design A two arm cluster controlled trial will be carried out at Pediatric Cardiology Department, FIC. This work will be conduct with the collaboration of a paeds cardiologist from FIC and their staff.

Participants All the participants who had registered and given consent in 1st study (From April 2021 to October 2021) will serve as the target population for the 2nd study. Families from the study one will be provided with the information about the second study and consent will be sought again for participation in this study. A purposive sample (n=60) of children adolescent and their families will be taken as participants in this study.

Inclusion Exclusion Criteria Parents of children with CHD below age 10 will be enrolled for the RCT trial. A sub sample considering the psychological portfolio obtained from the 1st study using purposive sampling technique will be recruited for both experimental and control group. Children with comorbidities and neurological deficits will be excluded.

Ethical Consideration The single blinded parallel randomized controlled trial has been approved by of Ethical Review Board of Faisalabad Institute of Cardiology (FIC) and University Ethical Committee of Government college university, Faisalabad. The registered sample will be informed about the nature and the purpose of the study. They will have right to choose/quit the study at any time. Informed consent will be obtained from the parents of children and adolescent. Assent from participants above age12 will also be obtained. The trial will be registered at provincial and national trial committee in Pakistan.

Procedure The study has already been approved from the Advanced Studies and Research Board of GC University Faisalabad and Faisalabad Institute of Cardiology, a tertiary care unit for ethical committee review. Personal informed consent of patients and their parents will be taken. Initially, permissions to use the psychological assessment tools will also sought from the original authors.

The registered participant in 1st study will get information letters explaining the purpose and the content of the study. The entire sample will be provided with a research card and reference code for registration and information. Randomization: After obtaining informed consent, families will receive an anonymous study code and will be invited for medical and psychological baseline assessments. Thereafter, controlling for age, gender, and severity of illness, the participants will be randomly assigned into groups (experimental, control).

IMPLICATIONS OF THE STUDY

Following are the implications of the study:

  1. The result will establish the efficacy of intervention based psychosocial care of youth with CHD and their parents in Pakistan
  2. The research will incorporate psychosocial care with CHD population along with their regular treatment and thus improve their future health related outcomes.
  3. The result of the research will facilitate the participating children and adolescents in their transition to adulthood thus helping them to become a functional part of the society.
  4. The research outcomes will pave the way for recruitment of health psychologist in pediatric cardiology units in Pakistan.
  5. The research will not only help parents to understand disease related physical but also psychological outcomes and facilitate them in managing their own stress and relation with the child according to his psychosocial needs

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Faisalābad, Punjab, Pakistan, 38000
        • Recruiting
        • Government College university ,Faisalabad and Faisalabad Institute of cardiology
        • Contact:
        • Sub-Investigator:
          • Dr abdurrazzak mughal, FCPS (Pediatrics Cardiology)
        • Sub-Investigator:
          • Dr Muhammad Zeshan, FCPS ( Child Psychiatry)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children and adolescents who will be diagnosed with Cyanotic CHD
  • able to understand Urdu language
  • patient with both gender will be included
  • intact families will be included

Exclusion Criteria:

  • single parents
  • parents having any psychiatric illness
  • Any chromosomal abnormality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Problem prevention therapy will be given as per intervention. a group of parents will be included for a group session for narration of their problems in relevance to health related quality of life .After the assessment the next session the solution to these problems would be given to them.
Behavioral: problem prevention therapy with CHD
The psychological exercises are based on the evidence-based Fun FRIENDS protocol (Burhanar, 2016) for reducing emotional behavioral issues. Separate workshop of adolescents will be designed based on transition in child cardiology to adult cardiology(Moons et al., 2009) . A cardiologist and psychologist will psycho educate them about self-care, needs of transition period and strength and strains about further life.
Other Names:
  • psycho education
Other: control group
for this group only a general education regarding disease will be conducted and no further interventions will be provide to them .
Behavioral: problem prevention therapy with CHD
The psychological exercises are based on the evidence-based Fun FRIENDS protocol (Burhanar, 2016) for reducing emotional behavioral issues. Separate workshop of adolescents will be designed based on transition in child cardiology to adult cardiology(Moons et al., 2009) . A cardiologist and psychologist will psycho educate them about self-care, needs of transition period and strength and strains about further life.
Other Names:
  • psycho education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paediatric quality of life
Time Frame: 6month
The Child and Parent reports of the paedsQl genric core scales for Young Children( ages 5-7) Children(8-12) Teens (13-18) 5 point Likert scale from 0 to 4 .Total scores will be Used to measure Health Related Quality of Life. High score indicate better quality of life .
6month
parenting stress Scale
Time Frame: 6month
The PSS is an eighteen item questionnaire assessing parent feeling about their parenting role, emotional and positive emotions , personal development and aspects of demands of parent hood. The parent stress scale was developed by Judy Berry and warren jones and can be used to assess outcomes of intervention designed to support parenting efficacy. High scores denotes higher level of stress in parents.
6month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
36 item short form survey
Time Frame: 1 year
The RAND 36 item health survey taps eight concept; physical functioning, Bodily pain, role limitations due to physical health problems and role limitations due to emotional health problems, Energy fatigue and general health. scoring involves two step process first preceded numeric values in second same was average together to create the scale scores. Higher score denotes better general health and well being
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Government College University Faisalabad

Investigators

  • Study Chair: Dr. Rabia Khawar, PhD, Department of Applied Psychology, GC University Faisalabad
  • Principal Investigator: Asma Riaz Hamdani, PhD Scholar, Department of Applied Psychology, GC University Faisalabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

September 4, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHDPIM1981

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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