Integrative Coping Group for Children

NCT01813669 | Completed

• 1 other identifier: Pro00039087
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Childhood anxiety; Pediatric Pain; Yoga; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in Psychological and Somatic Symptoms

  Baseline and approximately 13 weeks following the first group session

Study Arms (2)

Integrative Coping Group

EXPERIMENTAL

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

Behavioral: Integrative Coping Group

Waitlist Control

NO INTERVENTION

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

Integrative Coping Group BEHAVIORAL

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

Integrative Coping Group

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Migraine Disorders; Attention Deficit Disorder with Hyperactivity; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Mauro, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 19, 2013
• Study Start: October 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

US (1)