Clinical trial NCT05109806: Psychological Functioning of Children and Adolescents With CHD andTheir Parents, An Intervention Based Study
Official title: Psychological Functioning of Children & Adolescent With Congenital Heart Disease, and Their Parents: An Intervention Based Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Heart Disease
Psychological Intervention
Parenting
Quality of Life
Psychological Disturbance
Lead sponsor: Government College University Faisalabad
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has already approved from FIC a tertiary care unit for ethical committee review. Personal informed consent of patients and their parents will also be taken. Before starting the phases of study all the permissions regarding the measures will also be taken from original authors.

The registered participant in 1st study will get information letters explaining the purpose and the content of the study. All the participants will be given a research card and reference code for registration and information. Randomization: After informed consent have been obtained, Families will receive an anonymous study code and will be invited for medical and psychological baseline assessments. Thereafter, All participants will be randomly assigned to experimental and control groups.
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Paediatric quality of life
timeFrame: 6month
measure: parenting stress Scale
timeFrame: 6month
Secondary outcomes:
measure: 36 item short form survey
timeFrame: 1 year
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Government College university ,Faisalabad and Faisalabad Institute of cardiology
state: Punjab
Study officials:
affiliation: Department of Applied Psychology, GC University Faisalabad
name: Dr. Rabia Khawar, PhD
role: STUDY_CHAIR
affiliation: Department of Applied Psychology, GC University Faisalabad
name: Asma Riaz Hamdani, PhD Scholar
role: PRINCIPAL_INVESTIGATOR
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