Integrative Coping Group for Children

ADHD Clinical Trial

— ToPSY  

Official title:

Treatment of Psychosomatic Pain in Youth (ToPSY): A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813669
• Other study ID #: Pro00039087
• Status: Completed
• Phase: N/A
• First received: March 15, 2013
• Last updated: August 19, 2014
• Start date: October 2012
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Childhood Anxiety
• Childhood Depression
• Migraines
• Musculoskeletal Pain
• Pediatric Pain
• Pediatric Stomach Pain

Intervention

Behavioral:
• Integrative Coping Group
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

Locations

Country	Name	City	State
United States	Duke Child and Family Study Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12-week time frame for each group	No
Secondary	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.	Baseline and approximately 13 weeks following the first group session	No

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