ADHD Clinical Trial
— ToPSYOfficial title:
Treatment of Psychosomatic Pain in Youth (ToPSY): A Pilot Study
Verified date | August 2014 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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).
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke Child and Family Study Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
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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