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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Seattle Children's Hospital
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Tonya Palermo, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01496378
First received: December 19, 2011
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Chronic Pain
Abdominal Pain
Headache
Behavioral: Problem-Solving Skills Training
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Problem Solving Skills Training For Parent Caregivers of Youth With Chronic Pain

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, immediately post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Parents will complete the Brief Symptom Inventory, an 18-item questionnaire that assesses parental general psychological distress.

  • Treatment satisfaction [ Time Frame: immediately post-treatment and 3-month follow-up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: May 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Problem-Solving Skills Training
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.
Behavioral: Problem-Solving Skills Training
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
No Intervention: Standard Care
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.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496378

Contacts
Contact: Tonya M. Palermo, PhD 206-884-4208 tonya.palermo@seattlechildrens.org

Locations
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Michael Harris, PhD       harrismi@ohsu.edu   
Principal Investigator: Anna C. Wilson, PhD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Tonya M. Palermo, PhD    206-884-4208    tonya.palermo@seattlechildrens.org   
Principal Investigator: Tonya M. Palermo, PhD         
Sponsors and Collaborators
Seattle Children's Hospital
Oregon Health and Science University
Investigators
Principal Investigator: Tonya M. Palermo, PhD University of Washington
  More Information

No publications provided

Responsible Party: Tonya Palermo, Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01496378     History of Changes
Other Study ID Numbers: 1R21HD065180-01A1
Study First Received: December 19, 2011
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
Chronic Pain
Abdominal Pain
Headache
Adolescents
Children
Parents
Problem-Solving Skills Training

Additional relevant MeSH terms:
Headache
Chronic Pain
Abdominal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 19, 2014