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Problem Solving Skills Training For Parent Caregivers of Youth With Chronic Pain

Primary Purpose

Chronic Pain, Abdominal Pain, Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem-Solving Skills Training
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Abdominal Pain, Headache, Adolescents, Children, Parents, Problem-Solving Skills Training

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Oregon Health and Science University
  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Problem-Solving Skills Training

Standard Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.
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.
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.
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.

Secondary Outcome Measures

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.
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").
Brief symptom inventory
Parents will complete the Brief Symptom Inventory, an 18-item questionnaire that assesses parental general psychological distress.
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.

Full Information

First Posted
December 19, 2011
Last Updated
December 27, 2019
Sponsor
Seattle Children's Hospital
Collaborators
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT01496378
Brief Title
Problem Solving Skills Training For Parent Caregivers of Youth With Chronic Pain
Official Title
Problem Solving Skills Training For Parent Caregivers of Youth With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Abdominal Pain, Headache
Keywords
Chronic Pain, Abdominal Pain, Headache, Adolescents, Children, Parents, Problem-Solving Skills Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Problem-Solving Skills Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Problem-Solving Skills Training
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in problem solving skills from baseline to immediately post-treatment and 3-month follow-up
Description
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).
Time Frame
baseline, immediately post-treatment, 3-month follow-up
Title
Change in depressive symptoms from baseline to immediately post-treatment and 3-month follow-up
Description
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.
Time Frame
baseline, immediately post-treatment, 3-month follow-up
Title
Change in anxiety and depressive symptoms from baseline to immediately post-treatment and 3-month follow-up
Description
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.
Time Frame
baseline, immediately post-treatment, 3-month follow-up
Title
Change in parenting stress from baseline to immediately post-treatment and 3-month follow-up
Description
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.
Time Frame
baseline, post-treatment, 3-month follow-up
Title
Change in child physical and emotional functioning from baseline to immediately post-treatment and 3-month follow-up
Description
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.
Time Frame
baseline, post-treatment, 3-month follow-up
Secondary Outcome Measure Information:
Title
Change in parental impact of chronic pain from baseline to immediately post-treatment and 3-month follow-up
Description
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.
Time Frame
baseline, immediately post-treatment, and 3-month follow-up
Title
Treatment expectancies
Description
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").
Time Frame
baseline
Title
Brief symptom inventory
Description
Parents will complete the Brief Symptom Inventory, an 18-item questionnaire that assesses parental general psychological distress.
Time Frame
baseline
Title
Treatment satisfaction
Description
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.
Time Frame
immediately post-treatment and 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tonya M. Palermo, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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Problem Solving Skills Training For Parent Caregivers of Youth With Chronic Pain

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