Childhood DepressionToPSYNCT01813669
Integrative Coping Group for Children
A study testing Integrative Coping Group in people with Childhood Depression and Childhood Anxiety, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- Childhood Depression, Childhood Anxiety, Pediatric Pain
- What is being tested?
- Integrative Coping Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 9Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Child and Family Study Center
Durham, North Carolina, 27705
About this study
Official title: Treatment of Psychosomatic Pain in Youth (ToPSY): A Pilot Study
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).
Read the 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.
- Conditions
- Childhood Depression, Childhood Anxiety, Pediatric Pain, Migraines, ADHD, Pediatric Stomach Pain
- Being tested
- Integrative Coping Group
- Keywords
- Childhood anxiety, Pediatric Pain, Yoga, Cognitive behavioral therapy
- Medical subject headings
- Migraine Disorders, Attention Deficit Disorder with Hyperactivity, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Coping GroupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12-week time frame for each group
Secondary outcomes (1)
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.
Measured: Baseline and approximately 13 weeks following the first group session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood DepressionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Mauro, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813669
- Sponsor's protocol ID
- Pro00039087
- Acronym
- ToPSY
- Status last verified
- Aug 2014
- First submitted
- 15 Mar 2013
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Psychosomatic Pain in Youth (ToPSY): A Pilot Study
- ClinicalTrials.gov ID
- NCT01813669
- Acronym / sponsor ID
- ToPSY / Pro00039087
- Conditions
- Childhood Depression, Childhood Anxiety, Pediatric Pain, Migraines, ADHD, Pediatric Stomach Pain
- Keywords
- Childhood anxiety, Pediatric Pain, Yoga, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 19 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrative Coping Group | Experimental | Behavioral: Integrative Coping GroupThe 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 |
| 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. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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:
- presence of relevant somatic symptoms defined by a score of any one of the following:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative Coping GroupThe 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 | Behavioural | Integrative Coping Group |
Primary outcome
The percentage of children who complete 80% of the intervention sessions
Time frame: 12-week time frame for each group
Feasibility will be defined by 75% of children completing 80% of intervention sessions (i.e., 10/12 sessions).
1 secondary outcome
Change in Psychological and Somatic Symptoms
Time frame: Baseline and approximately 13 weeks following the first group session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
- Related InfoLink provided by the sponsor.
Related trials for Childhood Depression
Active, not recruiting
Resilient Students Training (ReST) : A Pilot RCT
Psychological Wellness
Active, not recruiting
Engagement in CHildhood-Onset Systemic Lupus
Lupus Erythematosus, Systemic, Depression
Active, not recruiting
Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
Safety, Psychological, Acceptability of Health Care
Not yet recruitingObservational study
Alexithymia, Pain Intensity, Quality of Life, and Psychological Symptoms in Chronic Coccydynia Patients Scheduled for Ganglion Impar Block
Coccydynia, Chronic Pain
Recruiting
Integrated Suicide & Trauma Therapy for Suicide Risk
Suicide, Trauma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Mauro, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Coping Group in people with Childhood Depression and Childhood Anxiety, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of children who complete 80% of the intervention sessions (time frame: 12-week time frame for each group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.