Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 5:14 AM
Study NCT ID:
NCT03800459
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2018-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Family Empowerment Program on Coping, Problem Solving in Parents, and Quality of Life in Children With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blindness in the study was done by data collectors and statisticians. The data were collected by the nurse who did not know who is in the experiment and control group.\n\nTo reduce selection bias and to control the variables that may have an effect on outcome variables, random assignment was made to the experimental and the control group by a statistician who did not know the names and characteristics of the parents of and children with CF. The analysis of the data coded according to the groups was made by a statistician. After the statistical analyses were completed and the research report was written, the researcher explained the coding for the experimental and control group.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2018-12-28', 'studyFirstSubmitQcDate': '2019-01-10', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child and parents information form', 'timeFrame': '3 weeks', 'description': 'The form was developed to define baseline characteristics and was based on previous literature. The questionnaire included questions regarding the sociodemographic characteristics of the participants, such as age, gender, educational level, income, duration of treatment and diagnosis.'}], 'secondaryOutcomes': [{'measure': 'Problem Solving Inventory (PSI)', 'timeFrame': '10 weeks', 'description': "Problem Solving Inventory (PSI) was measured using the 35-item Problem Solving Inventory Scale (Heppner \\& Petersen, 1982). PSI; is a 35-item measure with a six-point Likert scale that assesses an individual's perceptions of his or her problem-solving styles, rather than actual problem-solving skills. Higher scores indicate an individual's assessment of oneself as a relatively ineffective problem solver. The PSI has a total score derived from three scales. The three subscales are: (a) Problem-Solving Confidence (PSC, 11 items); (b) ApproachAvoidance Style (AAS, 16 items); and (c) Personal Control (PC, 5 items). The PSC refers to an individual's belief and trust in one's own problem-solving ability. The AAS is defined as a general tendency to approach or avoid a wide range of problem-solving activities. The PC refers to individual's belief that one is in control of his or her own behaviors and emotions while solving problems."}, {'measure': 'Scale of Ways of Coping with Stress (SWCS)', 'timeFrame': '10 weeks', 'description': "The SWCS was developed by Folkman and Lazarus in 1980 (Folkman \\& Lazarus 1980). The Turkish adaptation and validity study of SWCS was conducted by Şahin and Durak in 1995 (Şahin \\& Durak 1995). The SWCS is a 4-point Likert-type scale ranging from 1 (Not appropriate) to 4 (Very appropriate). In the Turkish adaptation and validity study of the SWCS, factor analysis, comparisons of measurement-correlating validity and counter groups and validity for the SWCS were conducted and Cronbach's alpha reliability coefficients of the subscales were found between 0.45 and 0.80. The scale consisted of two groups; one was the effective coping ways (ECWs), which contained the optimistic approach, self-confident approach, and seeking social support, and the other group was the ineffective coping ways (ICWs), which included the hopelessness and submissive approaches."}, {'measure': 'The Cystic Fibrosis Questionnaire-Revised (CFQ-R)', 'timeFrame': '10 weeks', 'description': 'The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a CF-specific health-related quality of life (HRQOL) questionnaire (Quiitner et al. in 2005). The CFQ-R is a 4-point Likert-type scale ranging from 1 to 4. Higher scores indicate better HRQOL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children with Cystic Fibrosis', 'Parents', 'Quality of Life', 'Coping with Stress', 'Problem Solving', 'family empowerment program', 'Nursing'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '39382937', 'type': 'DERIVED', 'citation': 'Donmez H, Tas Arslan F. The Effectiveness of a Parent Empowerment Intervention for Caregivers of Children with Cystic Fibrosis: A Randomized Controlled Trial. Compr Child Adolesc Nurs. 2024 Dec;47(4):267-283. doi: 10.1080/24694193.2024.2411986. Epub 2024 Oct 9.'}]}, 'descriptionModule': {'briefSummary': 'Parents of children with cystic fibrosis (CF) experience high levels of stress and problems. Family empowerment interventions provide important support for many patients with CF and their families. However,there is a lack of research exploring the effects of such empowerment programs on coping, and Problem Solving among parents, and Quality of Life in Children with CF.\n\nThe present study aimed to assess the effect of a family empowerment program-based nursing intervention on parents coping with stress and problem solving, and quality of life children with CF.', 'detailedDescription': 'Parents of children with cystic fibrosis (CF) experience high levels of stress and problems. Family empowerment interventions provide important support for many patients with CF and their families. However,there is a lack of research exploring the effects of such empowerment programs on coping, and Problem Solving among parents, and Quality of Life in Children with CF. The present study aimed to assess the effect of a family empowerment program-based nursing intervention on parents coping with stress and problem solving, and quality of life children with CF.\n\nA single-blinded, parallel group pretest and posttest design randomized controlled trial was used.\n\nData were collected over 5 months (January 2017-May 2017) from 48 participants in a medical faculty hospital. They were randomly assigned to the experimental (n = 24) and control (n = 24) groups. Nursing interventions applied to the experimental group for ten weeks with the intent of strengthening families consist of; providing individualized training and booklet concerning disease management and providing phone calls and consultancy services for the purpose of reinforcing the training and increasing the motivation. A routine polyclinic follow-up was applied to the control group. Problem Solving Inventory (PSI), Scale of Ways of Coping with Stress (SWCS), and The Cystic Fibrosis Questionnaire-Revised scale (CFQ-R) were used reliable and valid instruments. The data were evaluated using the Wilcoxon Signed Ranks test in evaluating dependent groups and the Mann-Whitney U test in independent groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6-18 years old;\n* Pulmonary functions Forced Expiratory Volume (FEV 1) over 40%\n* being able to communicate in Turkish,\n* voluntary parents in the study.\n\nExclusion Criteria:\n\n* had mental disorders;\n* receiving mechanical ventilation;\n* Being in the process of lung transplantation;\n* having a sister/brother who died due to CF\n* Being in enteral or parenteral feeding;\n* having a chronic disease other than CF.'}, 'identificationModule': {'nctId': 'NCT03800459', 'briefTitle': 'Effect of a Family Empowerment Program on Coping, Problem Solving in Parents, and Quality of Life in Children With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': 'Effect of a Family Empowerment Program on Coping With Stress, Problem Solving in Parents, and Quality of Life in Children With Cystic Fibrosis: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2017-4242'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Intervention group', 'description': 'Experimental: Intervention group', 'interventionNames': ['Behavioral: family empowerment program']}, {'type': 'NO_INTERVENTION', 'label': 'Control:no intervation group', 'description': 'Control:no intervation group'}], 'interventions': [{'name': 'family empowerment program', 'type': 'BEHAVIORAL', 'description': 'The empowerment program-nursing interventions were given in 6 sessions in the experimental group Session 1: Individualized training: General information about CF, respiratory system involvement and treatment process, airway cleaning in CF, drug applications (45-50 min) Session 2:Phone calls: Motivational and reminder interviews were carried out in order to reinforce the content of the first individual training (15 min).Session 3:Phone calls:Motivational and reminder interviews were carried out in order to reinforce the content of the first individual training (15 min) Session 4:Individualized training:protection from infections, nutrition and psychosocial support (45 min) Session 5:Phone calls: Motivational and reminder interviews were carried out in order to reinforce the content of the second individual training. (10 min) Session 6:Phone calls: Motivational and reminder interviews were carried out in order to reinforce the content of the second individual training. (10 min)', 'armGroupLabels': ['Experimental: Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42200', 'city': 'Konya', 'state': 'Eyalet/Yerleşke', 'country': 'Turkey (Türkiye)', 'facility': 'Selcuk University', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'Fatma Tas Arslan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Selcuk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selcuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Fatma Taş Arslan', 'investigatorAffiliation': 'Selcuk University'}}}}