Problem Solving Skills Training For Parent Caregivers of Youth With Chronic Pain - Full Text View

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:

MedlinePlus related topics: Abdominal Pain Anxiety Caregivers Chronic Pain Headache

U.S. FDA Resources

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:	May 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.

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

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 11, 2013
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:

Abdominal Pain
Headache
Pain
Signs and Symptoms

Signs and Symptoms, Digestive
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013