Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-02 @ 12:30 AM
Study NCT ID:
NCT07033832
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2025-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptance and Commitment Therapy-based Intervention for Parents of a Child With Medical Complexity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The project assistant who does not involve in intervention assignment and randomization, will help to conduct the data collection'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'single-blinded, pilot randomized controlled trial with two-armed repeated measures'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2025-06-06', 'studyFirstSubmitQcDate': '2025-06-14', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Depression Anxiety Stress Scale (Chinese version)', 'timeFrame': 'baseline, week 4', 'description': 'The DASS is a self-report instrument consisting of 21 items. It is rated on a 4-point scale from 1 (does not apply to me at all) to 4 (applies to me all the time). A higher score on the scale indicates more psychological symptoms.'}, {'measure': 'Psychological flexibility (Chinese version)', 'timeFrame': 'baseline, week 4', 'description': 'The Acceptance and Action Questionnaire-II was used to assess the psychological flexibility of parents. It consists of 7 items and is reported by the parent. Each item is rated on a 7-point Likert scale, ranging from 1 (never true) to 7 (always true).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acceptance and Commitment Therapy', 'Child With Medical Complexity', 'Psychological Flexibility', 'Randomised Controlled Trial', 'Depression, Anxiety', 'Parental Stress']}, 'descriptionModule': {'briefSummary': 'A pilot randomized controlled trial of an Acceptance and Commitment Therapy-based intervention will be conducted to decrease psychological symptoms, while increase psychological flexibility for parents of a child with medical complexity during their difficulties.', 'detailedDescription': 'Being a parent of the child with medical complexity poses enormous stress because CMC have a chronic complex health condition, which may result in premature death of the CMC. Psychological symptoms commonly experienced by the parents of a CMC. Having a CMC is an ongoing stressor including diagnosis, daily nursing care and symptom management, uncertainty of prognosis that can adequately fear the possibility of relapse. Therefore, seeking an intervention consisting of "Psychological flexibility" is crucial for these parents to manage their stress and difficult emotions more effectively. The ACT intervention help individuals concentrate more on their problems with positive attitude and take initiatives and workable actions to fix the problems associated from the caregiving activities. As a result, they will experience less stress when encountering difficulties and challenges and adapt more effectively. These individuals probably have the potential of natural recoveries from adverse events once the stressor is terminated.\n\nKnowledge gap: A review of the literature reveals a paucity of studies on ACT for Chinese parents of the CMC to decrease their psychological symptoms while enhancing their psychological flexibility in local communities. To fill the knowledge gap, this proposal therefore endeavors to develop an ACT and test its preliminary effects and feasibility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parent of a child with medical complexity aged 1-18\n* able to communicate in Chinese and read Chinese\n* willing to participate in face-to-face activities\n\nExclusion Criteria:\n\n* a reported mental health disorder\n* engaging in other psychosocial educational programs related to stress reduction\n* inability to communicate in Cantonese'}, 'identificationModule': {'nctId': 'NCT07033832', 'briefTitle': 'Acceptance and Commitment Therapy-based Intervention for Parents of a Child With Medical Complexity', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Acceptance and Commitment Therapy-based Intervention to Decrease Psychological Symptoms and Increase Psychological Flexibility for Parents of a Child With Medical Complexity: a Pilot Randomization-controlled Trial.', 'orgStudyIdInfo': {'id': 'PilotACT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACT-based intervention', 'description': 'The ACT-based intervention consists of four face-to-face weekly sessions. Parents in this group will receive two-hour weekly session with the question-and-answer session at the end.', 'interventionNames': ['Behavioral: ACT-based intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Parents of CMC have option to join the usual community social or health care available in the community.'}], 'interventions': [{'name': 'ACT-based intervention', 'type': 'BEHAVIORAL', 'description': 'Parents in this group will receive two-hour weekly session with the question-and-answer session at the end. The contents of each session are as follows: (1) the first session consist of introductions of ACT, discussion on stress and struggles, and setting homework, (2) the second section includes role play, and the meaning of "value", (3) the third session involves introducing mindfulness of the breath exercise, debrief and homework on practicing mindfulness and (4) the last session includes introduction of "thoughts", and putting values into feasible actions.', 'armGroupLabels': ['ACT-based intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Winsome Lam, PhD', 'role': 'CONTACT', 'email': 'winsome.lam@polyu.edu.hk', 'phone': '2766', 'phoneExt': '4291'}], 'facility': 'School of Nursing, The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '852', 'city': 'Kowloon', 'status': 'NOT_YET_RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'winsome LAM, PhD', 'role': 'CONTACT', 'email': 'winsome.lam@polyu.edu.hk', 'phone': '27664291'}], 'facility': 'School of Nursing The Hong Kong polytechnic university', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}], 'centralContacts': [{'name': 'Winsome Lam, PhD', 'role': 'CONTACT', 'email': 'winsome.lam@polyu.edu.hk', 'phone': '852-2766', 'phoneExt': '4291'}], 'overallOfficials': [{'name': 'Winsome LAM, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr Winsome Lam', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}