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

NCT01496378 | Completed DMC

• 1 other identifier: 1R21HD065180-01A1
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain; Abdominal Pain; Headache

Keywords

Chronic Pain; Abdominal Pain; Headache; Adolescents; Children; Parents; Problem-Solving Skills Training

Outcome Measures

Primary Outcomes (5)

• 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).

  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.

  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.

  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.

  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.

  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

  baseline, immediately post-treatment, and 3-month follow-up

• Treatment expectancies

  baseline

• Brief symptom inventory

  baseline

• Treatment satisfaction

  immediately post-treatment and 3-month follow-up

Study Arms (2)

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.

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.

Interventions

Problem-Solving Skills Training BEHAVIORAL

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

Problem-Solving Skills Training

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Oregon Health and Science University: collaborator

Study Sites (2)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Chronic Pain; Abdominal Pain; Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Tonya M. Palermo, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 21, 2011
• Study Start: May 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

US (2)