Chronic PainNCT01496378
Problem Solving Skills Training For Parent Caregivers of Youth With Chronic Pain
A study testing Problem-Solving Skills Training in people with Chronic Pain and Abdominal Pain, run by Seattle Children's Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the feasibility and efficacy of problem-solving skills training (PSST) to reduce distress and increase coping abilities among parents of youth with chronic pain. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Chronic Pain, Abdominal Pain, Headache
- What is being tested?
- Problem-Solving Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Mar 2015
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child age 10-17 years
- Child's pain present for at least 3 months duration
- Pain occurs at least 1 time per week and interferes with daily functioning
- Pain is not related to a chronic disease
- Receiving evaluation or treatment in a pediatric pain clinic
- Literate in English
Who cannot join
- A serious comorbid chronic condition in the child (e.g., diabetes, arthritis, cancer)
- Non-English speaking
- Parent has lived with the child for less than one year
- Parent has active psychosis or suicidal ideation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Health and Science University
Portland, Oregon, 97239
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
The purpose of this study is to evaluate the feasibility and efficacy of problem-solving skills training (PSST) to reduce distress and increase coping abilities among parents of youth with chronic pain. We hypothesize that parents will complete the PSST intervention and will find it to be an acceptable and satisfactory treatment. We also hypothesize that parents who receive PSST will have less distress and better coping skills than parents who receive standard care, and that children of parents who receive PSST will have better physical and emotional functioning than children of parents who receive standard care.
Read the detailed description
Chronic pain affects 25-40% of children and adolescents, and results in significantly lower quality of life for these youth. Parents play an important role in how their children cope with chronic pain, and can also experience their own distress related to their child's illness. Parental psychological distress is widely recognized to be associated with poorer child adjustment. However, no interventions have been developed specifically to treat psychological distress in parents of children with chronic pain. Problem-solving skills training (PSST) has been shown to result in significant reductions in parental distress among caregivers of children with other types of chronic illness such as cancer. The purpose of this study is to test the feasibility and preliminary efficacy of PSST for parents of youth with chronic pain.
- Conditions
- Chronic Pain, Abdominal Pain, Headache
- Being tested
- Problem-Solving Skills Training
- Keywords
- Chronic Pain, Abdominal Pain, Headache, Adolescents, Children, Parents, Problem-Solving Skills Training
- Medical subject headings
- Chronic Pain, Abdominal Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-Solving Skills TrainingBehavioural
Parents will receive 8, 1-hour sessions of individual problem-solving therapy over 8 weeks. Caregivers will complete the first training session and at least 3 subsequent sessions in person. Remaining sessions will be completed via telephone. In session 1, parents will be introduced to the PSST program and a rationale and explanation for problem solving strategies will be provided. During sessions 2-8, parents will identify a problem that they wish to work on. The therapist will use the primary cognitive-behavioral strategies of modeling, behavioral rehearsal, performance feedback, and generalization of skills in the process of teaching problem solving skills to parents. Parents will complete homework assignments to practice using the problem-solving skills in real-life situations
| Study group | Role | What they receive |
|---|---|---|
| Problem-Solving Skills Training | Experimental | In addition to standard medical care, parents in the problem-solving skills training group will receive 8 sessions (1 hour each) of individual problem-solving therapy over 8 weeks. Caregivers will be asked to complete the first training session and at least 3 subsequent sessions in person at their local treatment facility (Seattle Children's Hospital or Oregon Health and Science University). Remaining sessions will be completed via telephone. Receives: Behavioral: Problem-Solving Skills Training |
| Standard Care | No intervention | Parents and children in the Standard Care group will continue with the care that has been prescribed for their child's pain problem by their treating physician, which may include medications, physical therapy, and mental health intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in problem solving skills from baseline to immediately post-treatment and 3-month follow-up
Parent report of problem solving skills will be assessed using the Social Problem Solving Skills Inventory-Revised, which includes 52 items consisting of 5 scales that measure 2 different problem orientation dimensions (Positive and Negative) and three different problem-solving proper dimensions (Irrational Problem-Solving, Impulsivity/Carelessness Style, and Avoidance style).
Measured: baseline, immediately post-treatment, 3-month follow-up
Change in depressive symptoms from baseline to immediately post-treatment and 3-month follow-up
Parents will complete the Beck Depression Inventory-II (BDI-II) to assess parental depressive symptoms. The BDI-II is a 21-item measure that assesses the cognitive, affective, and behavioral components of depressive symptoms in adults.
Measured: baseline, immediately post-treatment, 3-month follow-up
Change in anxiety and depressive symptoms from baseline to immediately post-treatment and 3-month follow-up
Parents will complete the Profile of Mood States (POMS) to assess parent anxiety and depressive symptoms. The POMS is a 30-item measure that asks about feelings over the previous week. Six affective states are assessed: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. These subscales are combined to form a total POMS score.
Measured: baseline, immediately post-treatment, 3-month follow-up
Change in parenting stress from baseline to immediately post-treatment and 3-month follow-up
Parents will complete the Parenting Stress Index-Short Form(PSI-SF) to assess parenting stress. The PSI-SF is a 36-item questionnaire that assesses parental distress, parent-child dysfunctional interactions, and difficulty parenting.
Measured: baseline, post-treatment, 3-month follow-up
Change in child physical and emotional functioning from baseline to immediately post-treatment and 3-month follow-up
Children will complete the Bath Adolescent Pain Questionnaire (BAPQ), a 61-item measure that measures the impact of pain on child physical and emotional functioning. The BAPQ was developed specifically for children with chronic pain. Subscales measuring children's depression and physical functioning will be used in analyses.
Measured: baseline, post-treatment, 3-month follow-up
Secondary outcomes (4)
Change in parental impact of chronic pain from baseline to immediately post-treatment and 3-month follow-up
Parents will complete the Bath Adolescent Pain Questionnaire-Parent Impact to assess changes in functioning and behavior associated with parenting an adolescent with chronic pain. This is a 62-item scale. Two subscales will be used in analyses: child-related catastrophizing and parental behavior.
Measured: baseline, immediately post-treatment, and 3-month follow-up
Treatment expectancies
Parents will complete a 10-item treatment expectancies questionnaire to rate the likelihood that treatment will lead to symptom improvement on a 5-point rating scale (0="not at all likely" to 4="extremely likely").
Measured: baseline
Brief symptom inventory
Parents will complete the Brief Symptom Inventory, an 18-item questionnaire that assesses parental general psychological distress.
Measured: baseline
Treatment satisfaction
Parents will complete an 8-item scale regarding satisfaction with the therapeutic process during the course of treatment and satisfaction with the outcome of therapy.
Measured: immediately post-treatment and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startMay 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Tonya Palermo, Seattle Children's Hospital
- Investigators
- Tonya M. Palermo, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496378
- Sponsor's protocol ID
- 1R21HD065180-01A1
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2011
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Problem Solving Skills Training For Parent Caregivers of Youth With Chronic Pain
- ClinicalTrials.gov ID
- NCT01496378
- Acronym / sponsor ID
- 1R21HD065180-01A1
- Conditions
- Chronic Pain, Abdominal Pain, Headache
- Keywords
- Chronic Pain, Abdominal Pain, Headache, Adolescents, Children, Parents, Problem-Solving Skills Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- May 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Dec 2011 (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 evaluate the feasibility and efficacy of problem-solving skills training (PSST) to reduce distress and increase coping abilities among parents of youth with chronic pain. We hypothesize that parents will complete the PSST intervention and will find it to be an acceptable and satisfactory treatment. We also hypothesize that parents who receive PSST will have less distress and better coping skills than parents who receive standard care, and that children of parents who receive PSST will have better physical and emotional functioning than children of parents who receive standard care.
Detailed description
Chronic pain affects 25-40% of children and adolescents, and results in significantly lower quality of life for these youth. Parents play an important role in how their children cope with chronic pain, and can also experience their own distress related to their child's illness. Parental psychological distress is widely recognized to be associated with poorer child adjustment. However, no interventions have been developed specifically to treat psychological distress in parents of children with chronic pain. Problem-solving skills training (PSST) has been shown to result in significant reductions in parental distress among caregivers of children with other types of chronic illness such as cancer. The purpose of this study is to test the feasibility and preliminary efficacy of PSST for parents of youth with chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem-Solving Skills Training | Experimental | Behavioral: Problem-Solving Skills TrainingIn addition to standard medical care, parents in the problem-solving skills training group will receive 8 sessions (1 hour each) of individual problem-solving therapy over 8 weeks. Caregivers will be asked to complete the first training session and at least 3 subsequent sessions in person at their local treatment facility (Seattle Children's Hospital or Oregon Health and Science University). Remaining sessions will be completed via telephone. |
| Standard Care | No intervention | –Parents and children in the Standard Care group will continue with the care that has been prescribed for their child's pain problem by their treating physician, which may include medications, physical therapy, and mental health intervention. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child age 10-17 years
- Child's pain present for at least 3 months duration
- Pain occurs at least 1 time per week and interferes with daily functioning
- Pain is not related to a chronic disease
- Receiving evaluation or treatment in a pediatric pain clinic
Key exclusion criteria (4 listed)
- A serious comorbid chronic condition in the child (e.g., diabetes, arthritis, cancer)
- Non-English speaking
- Parent has lived with the child for less than one year
- Parent has active psychosis or suicidal ideation
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 |
|---|---|---|
| Problem-Solving Skills TrainingParents will receive 8, 1-hour sessions of individual problem-solving therapy over 8 weeks. Caregivers will complete the first training session and at least 3 subsequent sessions in person. Remaining sessions will be completed via telephone. In session 1, parents will be introduced to the PSST program and a rationale and explanation for problem solving strategies will be provided. During sessions 2-8, parents will identify a problem that they wish to work on. The therapist will use the primary cognitive-behavioral strategies of modeling, behavioral rehearsal, performance feedback, and generalization of skills in the process of teaching problem solving skills to parents. Parents will complete homework assignments to practice using the problem-solving skills in real-life situations | Behavioural | Problem-Solving Skills Training |
Primary outcome
Change in problem solving skills from baseline to immediately post-treatment and 3-month follow-up
Time frame: baseline, immediately post-treatment, 3-month follow-up
Parent report of problem solving skills will be assessed using the Social Problem Solving Skills Inventory-Revised, which includes 52 items consisting of 5 scales that measure 2 different problem orientation dimensions (Positive and Negative) and three different problem-solving proper dimensions (Irrational Problem-Solving, Impulsivity/Carelessness Style, and Avoidance style).
Change in depressive symptoms from baseline to immediately post-treatment and 3-month follow-up
Time frame: baseline, immediately post-treatment, 3-month follow-up
Parents will complete the Beck Depression Inventory-II (BDI-II) to assess parental depressive symptoms. The BDI-II is a 21-item measure that assesses the cognitive, affective, and behavioral components of depressive symptoms in adults.
Change in anxiety and depressive symptoms from baseline to immediately post-treatment and 3-month follow-up
Time frame: baseline, immediately post-treatment, 3-month follow-up
Parents will complete the Profile of Mood States (POMS) to assess parent anxiety and depressive symptoms. The POMS is a 30-item measure that asks about feelings over the previous week. Six affective states are assessed: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. These subscales are combined to form a total POMS score.
Change in parenting stress from baseline to immediately post-treatment and 3-month follow-up
Time frame: baseline, post-treatment, 3-month follow-up
Parents will complete the Parenting Stress Index-Short Form(PSI-SF) to assess parenting stress. The PSI-SF is a 36-item questionnaire that assesses parental distress, parent-child dysfunctional interactions, and difficulty parenting.
Change in child physical and emotional functioning from baseline to immediately post-treatment and 3-month follow-up
Time frame: baseline, post-treatment, 3-month follow-up
Children will complete the Bath Adolescent Pain Questionnaire (BAPQ), a 61-item measure that measures the impact of pain on child physical and emotional functioning. The BAPQ was developed specifically for children with chronic pain. Subscales measuring children's depression and physical functioning will be used in analyses.
4 secondary outcomes
Change in parental impact of chronic pain from baseline to immediately post-treatment and 3-month follow-up
Time frame: baseline, immediately post-treatment, and 3-month follow-up
Treatment expectancies
Time frame: baseline
Brief symptom inventory
Time frame: baseline
Treatment satisfaction
Time frame: immediately post-treatment and 3-month follow-up
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 2 Jan 2020.
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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.
Tonya M. Palermo, PhD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem-Solving Skills Training in people with Chronic Pain and Abdominal Pain, run by Seattle Children's Hospital at 2 sites 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 6 inclusion and 4 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in problem solving skills from baseline to immediately post-treatment and 3-month follow-up (time frame: baseline, immediately post-treatment, 3-month follow-up). The study lists 5 primary outcomes in all. 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 2 Jan 2020.