Problem Solving Skills Training For Parent Caregivers of Youth With Chronic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01496378|
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : May 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Abdominal Pain Headache||Behavioral: Problem-Solving Skills Training||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Problem Solving Skills Training For Parent Caregivers of Youth With Chronic Pain|
|Study Start Date :||May 2012|
|Primary Completion Date :||March 2015|
|Study Completion Date :||March 2015|
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.
- 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.
- 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 ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496378
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Tonya M. Palermo, PhD||University of Washington|