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Integrative Coping Group for Children (ToPSY)

Primary Purpose

Childhood Depression, Childhood Anxiety, Pediatric Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrative Coping Group
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Depression focused on measuring Childhood anxiety, Pediatric Pain, Yoga, Cognitive behavioral therapy

Eligibility Criteria

10 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Children between the ages of 10- and 12-years old;
  2. Presence of clinically-relevant internalizing symptoms (e.g., anxiety or depression) as defined by any of the following:

    1. T-score ≥ 65 on the Anxiety or Depression subscales of the CBCL;
    2. T-score ≥ 65 on any of the subscales of the RCADS;
    3. Currently receiving psychotherapy or prescribed psychotropic medication to treat identified psychological distress;
  3. presence of relevant somatic symptoms defined by a score of any one of the following:

    1. T-score ≥ 65 on the Somatic subscale of the Child Behavior Checklist (CBCL);
    2. Raw score > 10 on the parent- or child-rated CSI-24;
    3. Current medical intervention for somatic pain in the absence of an organic disease (e.g., medical treatment for migraines or irritable bowel syndrome)

Exclusion Criteria:

  1. 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;
  2. A diagnosis of a pervasive developmental disorder (by history); a current eating disorder, including anorexia nervosa, bulimia, or binge eating disorder; active psychosis;
  3. A history of drug, alcohol or chemical abuse within 6-months prior to screening;
  4. Non-English speaking;
  5. Participation in a current structured yoga practice

Sites / Locations

  • Duke Child and Family Study Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Integrative Coping Group

Waitlist Control

Arm 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: Module 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

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.

Outcomes

Primary Outcome Measures

The percentage of children who complete 80% of the intervention sessions
Feasibility will be defined by 75% of children completing 80% of intervention sessions (i.e., 10/12 sessions).

Secondary Outcome Measures

Change in Psychological and Somatic Symptoms
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.

Full Information

First Posted
March 15, 2013
Last Updated
August 19, 2014
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT01813669
Brief Title
Integrative Coping Group for Children
Acronym
ToPSY
Official Title
Treatment of Psychosomatic Pain in Youth (ToPSY): A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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. Yoga-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: Specific Aim 1 Treatment Feasibility: Assess the feasibility of a novel integrative coping intervention for children with somatic symptoms and anxiety. Hypothesis: 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. Secondary 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. Hypothesis: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Depression, Childhood Anxiety, Pediatric Pain, Migraines, ADHD, Pediatric Stomach Pain, Musculoskeletal Pain
Keywords
Childhood anxiety, Pediatric Pain, Yoga, Cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrative Coping Group
Arm Type
Experimental
Arm 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: Module 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
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Integrative Coping Group
Intervention 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: Module 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
Primary Outcome Measure Information:
Title
The percentage of children who complete 80% of the intervention sessions
Description
Feasibility will be defined by 75% of children completing 80% of intervention sessions (i.e., 10/12 sessions).
Time Frame
12-week time frame for each group
Secondary Outcome Measure Information:
Title
Change in Psychological and Somatic Symptoms
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.
Time Frame
Baseline and approximately 13 weeks following the first group session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children between the ages of 10- and 12-years old; Presence of clinically-relevant internalizing symptoms (e.g., anxiety or depression) as defined by any of the following: T-score ≥ 65 on the Anxiety or Depression subscales of the CBCL; T-score ≥ 65 on any of the subscales of the RCADS; Currently receiving psychotherapy or prescribed psychotropic medication to treat identified psychological distress; presence of relevant somatic symptoms defined by a score of any one of the following: T-score ≥ 65 on the Somatic subscale of the Child Behavior Checklist (CBCL); Raw score > 10 on the parent- or child-rated CSI-24; Current medical intervention for somatic pain in the absence of an organic disease (e.g., medical treatment for migraines or irritable bowel syndrome) Exclusion Criteria: 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; A diagnosis of a pervasive developmental disorder (by history); a current eating disorder, including anorexia nervosa, bulimia, or binge eating disorder; active psychosis; A history of drug, alcohol or chemical abuse within 6-months prior to screening; Non-English speaking; Participation in a current structured yoga practice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Mauro, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Child and Family Study Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.dukehealth.org/events/integrative-coping-skills-group
Description
Related Info

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