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

NCT05109806 | Unknown

• 1 other identifier: CHDPIM1981
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease; Psychological Intervention; Parenting; Quality of Life; Psychological Disturbance

Outcome Measures

Primary Outcomes (2)

• Paediatric quality of life

  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

  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 Outcomes (1)

• 36 item short form survey

  1 year

Study Arms (2)

Experimental group

EXPERIMENTAL

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

control group

OTHER

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

Interventions

problem prevention therapy with CHD BEHAVIORAL

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.

Also known as: psycho education

Experimental group; control group

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Government College University Faisalabad: lead

Study Sites (1)

Government College university ,Faisalabad and Faisalabad Institute of cardiology

Faisalābad, Punjab Province, 38000, Pakistan

RECRUITING

Related Publications (7)

• van der Mheen M, van Beynum IM, Dulfer K, van der Ende J, van Galen E, Duvekot J, Rots LE, van den Adel TPL, Bogers AJJC, McCusker CG, Casey FA, Helbing WA, Utens EMWJ. The CHIP-Family study to improve the psychosocial wellbeing of young children with congenital heart disease and their families: design of a randomized controlled trial. BMC Pediatr. 2018 Jul 12;18(1):230. doi: 10.1186/s12887-018-1183-y.

  PMID: 30001701 BACKGROUND

• Lawoko S, Soares JJ. Psychosocial morbidity among parents of children with congenital heart disease: a prospective longitudinal study. Heart Lung. 2006 Sep-Oct;35(5):301-14. doi: 10.1016/j.hrtlng.2006.01.004.

  PMID: 16963362 BACKGROUND

• Lisanti AJ. Parental stress and resilience in CHD: a new frontier for health disparities research. Cardiol Young. 2018 Sep;28(9):1142-1150. doi: 10.1017/S1047951118000963. Epub 2018 Jul 11.

  PMID: 29991369 BACKGROUND

• Moons P, Pinxten S, Dedroog D, Van Deyk K, Gewillig M, Hilderson D, Budts W. Expectations and experiences of adolescents with congenital heart disease on being transferred from pediatric cardiology to an adult congenital heart disease program. J Adolesc Health. 2009 Apr;44(4):316-22. doi: 10.1016/j.jadohealth.2008.11.007. Epub 2009 Feb 12.

  PMID: 19306789 BACKGROUND

• Ogundele MO. Behavioural and emotional disorders in childhood: A brief overview for paediatricians. World J Clin Pediatr. 2018 Feb 8;7(1):9-26. doi: 10.5409/wjcp.v7.i1.9. eCollection 2018 Feb 8.

  PMID: 29456928 BACKGROUND

• Samad L, Hollis C, Prince M, Goodman R. Child and adolescent psychopathology in a developing country: testing the validity of the strengths and difficulties questionnaire (Urdu version). Int J Methods Psychiatr Res. 2005;14(3):158-66. doi: 10.1002/mpr.3.

  PMID: 16389892 BACKGROUND

• Biber S, Andonian C, Beckmann J, Ewert P, Freilinger S, Nagdyman N, Kaemmerer H, Oberhoffer R, Pieper L, Neidenbach RC. Current research status on the psychological situation of parents of children with congenital heart disease. Cardiovasc Diagn Ther. 2019 Oct;9(Suppl 2):S369-S376. doi: 10.21037/cdt.2019.07.07.

  PMID: 31737543 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dr. Rabia Khawar, PhD

  Department of Applied Psychology, GC University Faisalabad

  STUDY CHAIR

• Asma Riaz Hamdani, PhD Scholar

  Department of Applied Psychology, GC University Faisalabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ASMA HUMDANI, PhD scholar

CONTACT

0419200952; asmariaz@gcuf.edu.pk

Dr. Abdurrazaq Mughal, FCPS

CONTACT

9203219668229; a.razzaq.cs@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants are only blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: November 5, 2021
• Study Start: May 7, 2021
• Primary Completion: March 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)