Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-02 @ 8:30 PM
Study NCT ID:
NCT01813669
Status:
COMPLETED
Last Update Posted:
2014-08-20
First Post:
2013-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrative Coping Group for Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-19', 'studyFirstSubmitDate': '2013-03-15', 'studyFirstSubmitQcDate': '2013-03-15', 'lastUpdatePostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of children who complete 80% of the intervention sessions', 'timeFrame': '12-week time frame for each group', 'description': 'Feasibility will be defined by 75% of children completing 80% of intervention sessions (i.e., 10/12 sessions).'}], 'secondaryOutcomes': [{'measure': 'Change in Psychological and Somatic Symptoms', 'timeFrame': 'Baseline and approximately 13 weeks following the first group session', 'description': "Defined as a significant reduction in somatic and anxiety symptoms following the 12-week intervention compared to the between-subjects wait-list control group and within-subject baseline scores. This will be determined based on the children's and parents' responses on the Revised Child Anxiety and Depression Scale (RCADS), the Children's Somatization Inventory-24, and the Child Behavior Checklist."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Childhood anxiety', 'Pediatric Pain', 'Yoga', 'Cognitive behavioral therapy'], 'conditions': ['Childhood Depression', 'Childhood Anxiety', 'Pediatric Pain', 'Migraines', 'ADHD', 'Pediatric Stomach Pain', 'Musculoskeletal Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.dukehealth.org/events/integrative-coping-skills-group', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether an integrative group-based intervention will help children experiencing psychological and physical distress. Children, ages 10 to 12, will be recruited for participation in this therapeutic group. Eligible and consenting participants will be randomized to a wait-list control group or the group intervention. The group intervention will take place over a 12-week period, during which participants will attend a weekly coping skills group that integrates yoga-based practices (such as yoga poses, mindfulness, self-acceptance, breath work) with cognitive-behavioral principles (such as increasing awareness of thoughts and emotions).', 'detailedDescription': "Psychosomatic symptoms are physical complaints in the absence of an organic cause. For children and adolescents, psychosomatic symptoms often manifest as headaches, gastrointestinal (GI) discomfort, non-specific musculoskeletal pain, and fatigue. These symptoms are strongly associated with the presence of an internalizing disorder-namely, anxiety or depression-in youth. Thus, treatment of these symptoms has often been cached within a broader intervention protocol, the overarching goal of which is to address the global internalizing disorder. For children who experience intense and persistent psychosomatic discomfort, however, it can be critical to specifically target these symptoms through intensive intervention. Otherwise, psychosomatic complaints can be extremely impairing, impeding children's attendance in school, participation in extracurricular activities, and disrupting family activities. At present, there are few systematic that can target a range of psychosomatic problems.\n\nYoga-based interventions may be a particularly valuable treatment for children with psychosomatic complaints. Such interventions have been studied empirically in adults with a number of psychosomatic conditions, and more recently in children with a variety of psychological conditions. Indeed, there have been a small number of studies targeting psychosomatic complaints in children via yogic practices. Although there is emerging interest in yoga-based interventions for youth, and slowly growing evidence their efficacy, at present there are no known structured interventions for youth with psychosomatic complaints in the context of an internalizing disorder. Thus, the goal of the present proposal is to develop a semi-structured, manualized intervention that targets impairing psychosomatic symptoms in youth with a comorbid internalizing disorders. The specific aims are as follows:\n\nSpecific Aim 1 Treatment Feasibility: Assess the feasibility of a novel integrative coping intervention for children with somatic symptoms and anxiety.\n\nHypothesis: The yoga-based intervention will be acceptable and feasible for children. Acceptability will be defined as a 50% consent rate among participants approached for the study; Feasibility will be defined by 75% of children completing 80% of intervention sessions.\n\nSecondary Aim 1 Treatment Efficacy: Assess the preliminary efficacy of a 12-week integrative coping intervention on both somatic and psychological (e.g., anxiety, mood) symptoms compared to a wait-list control condition.\n\nHypothesis: Children in the active intervention condition will have a significant reduction in somatic and anxiety symptoms following the 12-week intervention compared to a wait-list control."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children between the ages of 10- and 12-years old;\n2. Presence of clinically-relevant internalizing symptoms (e.g., anxiety or depression) as defined by any of the following:\n\n 1. T-score ≥ 65 on the Anxiety or Depression subscales of the CBCL;\n 2. T-score ≥ 65 on any of the subscales of the RCADS;\n 3. Currently receiving psychotherapy or prescribed psychotropic medication to treat identified psychological distress;\n3. presence of relevant somatic symptoms defined by a score of any one of the following:\n\n 1. T-score ≥ 65 on the Somatic subscale of the Child Behavior Checklist (CBCL);\n 2. Raw score \\> 10 on the parent- or child-rated CSI-24;\n 3. Current medical intervention for somatic pain in the absence of an organic disease (e.g., medical treatment for migraines or irritable bowel syndrome)\n\nExclusion Criteria:\n\n1. The presence of a physical handicap or injury that prevents participation or puts them at a high risk for further injury in the integrative intervention;\n2. A diagnosis of a pervasive developmental disorder (by history); a current eating disorder, including anorexia nervosa, bulimia, or binge eating disorder; active psychosis;\n3. A history of drug, alcohol or chemical abuse within 6-months prior to screening;\n4. Non-English speaking;\n5. Participation in a current structured yoga practice'}, 'identificationModule': {'nctId': 'NCT01813669', 'acronym': 'ToPSY', 'briefTitle': 'Integrative Coping Group for Children', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Treatment of Psychosomatic Pain in Youth (ToPSY): A Pilot Study', 'orgStudyIdInfo': {'id': 'Pro00039087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Integrative Coping Group', 'description': 'The proposed 12-week intervention will integrate yoga-based skills with cognitive-behavioral principles. The development of this program was based on existing and empirically-validated cognitive-behavioral interventions for youth (i.e., Coping Cat and Cat Project; Kendall et al.) and therapeutic yoga interventions (e.g., Galantino et al., 2008 for review). The intervention will be broken down into four three-week modules, which address the following:\n\nModule 1: Introduction to group and awareness of body Module 2: Awareness of emotion and developing an understanding of the mind-body connection Module 3: Focus on cognitive process Module 4: Experiential practice and therapeutic discussions', 'interventionNames': ['Behavioral: Integrative Coping Group']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Control', 'description': 'Participants in the waitlist condition will not receive any experimental intervention. They can continue any treatments as usual. The waitlist will be approximately 10-14 weeks in duration. At the end they will be offered the opportunity to participate in the intervention. If they elect to participate in the intervention, post-study data will also be collected from this group, approximately 13-weeks following the first group session.'}], 'interventions': [{'name': 'Integrative Coping Group', 'type': 'BEHAVIORAL', 'description': 'The proposed 12-week intervention will integrate yoga-based skills with cognitive-behavioral principles. The development of this program was based on existing and empirically-validated cognitive-behavioral interventions for youth (i.e., Coping Cat and Cat Project; Kendall et al.) and therapeutic yoga interventions (e.g., Galantino et al., 2008 for review). The intervention will be broken down into four three-week modules, which address the following:\n\nModule 1: Introduction to group and awareness of body Module 2: Awareness of emotion and developing an understanding of the mind-body connection Module 3: Focus on cognitive process Module 4: Experiential practice and therapeutic discussions', 'armGroupLabels': ['Integrative Coping Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Child and Family Study Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Christian Mauro, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}