Pilot Trial of a Meaning And Problem-Solving (MAPS) Intervention for Family Caregivers of Children With Medical Complexity

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Study arms

• Experimental
  MAPS Intervention

  Participants randomized to this experimental arm will undergo 8 one-on-one sessions with a trained MAPS interventionist over 2-3 months. Sessions can be conducted in-person or via videoconference (per participant preference); and will last 45- to 60-minutes in duration.

  Behavioral: MAPS (Meaning And Problem Solving)

• Active comparator
  Usual Psychosocial Care

  Participants randomized to the comparison arm will receive usual psychosocial care services routinely provided by our institution's pediatric complex care and palliative care interdisciplinary team. This psychosocial care includes routine clinical evaluations, emotional and social support, and care coordination services, which are delivered via scheduled outpatient clinic visits, phone/virtual consultations, or inpatient visits.

  Behavioral: Usual Psychosocial Care

Interventions

• BehavioralMAPS (Meaning And Problem Solving)

  The MAPS intervention is a manualized behavioral program, tailored for family caregivers of children with medical complexity, which consists of 8 one-on-one 45-60 minute sessions delivered by a trained interventionist. The intervention aims to improve participant mental health and emotional well-being by enhancing participants' sense of meaning and problem-solving skills. Key components adapted from meaning-centered psychotherapy include: identifying sources of meaning, guided imagery, personalized coping statements, meaningful activity scheduling, and values-based goal setting. Problem-solving skills-training is adapted from Bright IDEAS, a 5-step framework to teach problem-solving skills originally developed for mothers of children with cancer. Participants receive a workbook with reference materials, worksheets, and home practice exercises to promote skill mastery and routine maintenance.

• BehavioralUsual Psychosocial Care

  Participants randomized to the comparison arm will receive usual psychosocial care services routinely provided by our institution's pediatric complex care and palliative care interdisciplinary team. This psychosocial care includes routine clinical evaluations, emotional and social support, and care coordination services, which are delivered via scheduled outpatient clinic visits, phone/virtual consultations, or inpatient visits.

Primary outcomes

1. Feasibility: Recruitment Rate

   Percentage of eligible caregivers approached who consent to participate, and percentage of consented participants who are successfully enrolled.

   Time frame: Approach-to-Consent: from initial approach to 12 weeks after initial approach. Consent-to-Enroll: 12 weeks from obtaining written informed consent .

2. Feasibility: Retention Rate

   Percentage of randomized participants who complete the study protocol.

   Time frame: From study enrollment to 12-weeks post-enrollment

3. Feasibility: Data Collection Completion Rate

   Percentage of required participant-reported outcome assessments successfully completed across all study time points.

   Time frame: From study enrollment to 12-weeks post-enrollment

4. Feasibility: Intervention Session Completion

   Percentage of planned intervention sessions completed by end of trial.

   Time frame: From study enrollment to 12-weeks post-enrollment

5. Feasibility: Intervention Fidelity

   Adherence of interventionists to protocol content, delivery, and procedures, evaluated using an intervention fidelity scoring matrix. For all intervention sessions, this matrix assesses the following domains: rapport building, professionalism, flexibility, engagement, protocol application, and pacing. Each domain is assessed on a 5-point Likert scale (Poor \[1\] to Excellent \[5\]). Additionally, each session will be assessed for delivery of session-specific content (e.g., "discussing concept of meaning"), also using a 5-point Likert scale. Session intervention fidelity will be calculated by averaging rating for each element; higher scores represent higher intervention fidelity.

   Time frame: From study enrollment to 12-weeks post-enrollment

6. Intervention and Trial Protocol Acceptability

   Percentage of participants reporting high acceptability ("agree" or "completely agree") to participating in the intervention and trial protocol on post-study exit questionnaire.

   Time frame: From study enrollment to 12-weeks post-enrollment

7. Satisfaction with Intervention

   Percentage of participants reporting high satisfaction ("satisfied" or "very satisfied") in the experiences with the MAPS intervention in post-study evaluation questionnaire.

   Time frame: From study enrollment to 12-weeks post-enrollment.

Secondary outcomes

1. Change in Meaning-Focused Coping (PROMIS Item Bank v1.0 - Meaning and Purpose - Short Form 8a)

   Assessed using the 8-item PROMIS Meaning and Purpose Short Form. Items evaluate self-reported sense of life direction, purpose, and value on a 5-point Likert scale (1 = "Not at all" to 5 = "Very much"). Item scores are summed and converted to a standardized T-score (mean = 50, SD = 10; typical range: 24.3 to 68.2). Higher T-scores indicate a higher sense of meaning and purpose.

   Time frame: Baseline and 12-weeks post-enrollment

2. PROMIS General Self-Efficacy

   Assessed using the PROMIS General Self-Efficacy scale. Items evaluate a person's general confidence in their ability to carry out tasks and reach goals. Items are scored on a 5-point Likert scale and converted to a standardized T-score (mean = 50, standard deviation = 10; typical range approximately 20 to 80). Higher T-scores reflect greater general self-efficacy.

   Time frame: Baseline and 12-weeks post-enrollment

3. Change in Emotional Regulation Self-Efficacy (PROMIS Item Bank v1.0 - Self-Efficacy for Managing Emotions - Short Form 8a)

   Assessed using the 8-item PROMIS Self-Efficacy for Managing Emotions Short Form. Items evaluate confidence in managing difficult emotional states on a 5-point Likert scale (1 = "I am not at all confident" to 5 = "I am very confident"). Item scores are summed and converted to a standardized T-score (mean = 50, SD = 10; typical range: 25.8 to 64.2). Higher T-scores represent greater self-efficacy for emotional regulation.

   Time frame: Baseline and 12-weeks post-enrollment

4. Change in Positive Affect (PROMIS Positive Affect Short Form)

   Assessed using the PROMIS Positive Affect Short Form (15 items). Items evaluate feelings of happiness, joy, and positive emotional states over the past 7 days on a 5-point Likert scale. Scores are converted to a standardized T-score (mean = 50, standard deviation = 10; range approximately 20 to 80). Higher T-scores indicate higher levels of positive affect.

   Time frame: Baseline and 12-weeks post-enrollment

5. Change in Emotional Distress (PROMIS Anxiety, Depression, and Anger Short Forms)

   Assessed using the PROMIS Anxiety Short Form (8 items), PROMIS Depression Short Form (8 items) and PROMIS Anger Short Form (5 items). Items evaluate self-reported symptoms over the past 7 days on a 5-point Likert scale. Each domain generates a separate standardized T-score (mean = 50, standard deviation = 10; range approximately 20 to 80). Higher T-scores indicate higher levels of anxiety, depression, and anger (greater emotional distress).

   Time frame: Baseline and 12-weeks post-enrollment

6. Change in Emotional Support (PROMIS Item Bank v2.0 - Emotional Support - Short Form 8a)

   Assessed using the 8-item PROMIS Emotional Support Short Form. Items evaluate perceived feelings of being cared for and having someone to listen to or confide in on a 5-point Likert scale (1 = "Never" to 5 = "Always"). Raw scores are converted to a standardized T-score (mean = 50, SD = 10; typical range: 25.3 to 63.8). Higher T-scores indicate higher levels of perceived emotional support.

   Time frame: Baseline and 12-weeks post-enrollment

7. Change in Global Health (PROMIS Scale v1.2 - Global Health)

   Assessed using the 10-item PROMIS Global Health scale. Items evaluate overall perceptions of general health, physical health, mental health, quality of life, social activities, and pain/fatigue on 5-point Likert scales. Items are summarized into two primary domain subscales: Global Physical Health (GPH) and Global Mental Health (GMH). Raw subscale scores are converted to standardized T-scores (mean = 50, SD = 10; range: 16.2 to 67.7). Higher T-scores indicate better health functioning.

   Time frame: Baseline and 12-weeks post-enrollment

8. Change in Child Global Health (PROMIS Early Childhood Global Health)

   Assessed using the parent-proxy PROMIS Early Childhood Global Health Module (8 items). Evaluates the child's overall physical, mental, and social health status on a 5-point scale. Raw scores are converted to a standardized T-score (mean = 50, SD = 10; range: approx. 16.2 to 66.8). Higher T-scores represent better overall child health status.

   Time frame: Baseline and 12-weeks post-enrollment

9. Change in Spiritual Well-Being (FACIT-Sp-12)

   Assessed using the 12-item Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-Sp-12). Items evaluate spiritual well-being across two main domains (Meaning/Peace and Faith) or three subdomains (Meaning, Peace, and Faith) on a 5-point Likert scale (0 = "Not at all" to 4 = "Very much"). Total scores range from 0 to 48, with higher scores indicating greater spiritual well-being and a stronger sense of meaning, peace, and faith.

   Time frame: Baseline and 12-weeks post-enrollment

10. Change in Social Problem-Solving Ability (SPSI-R:SF)

    Assessed using the 25-item Social Problem-Solving Inventory-Revised Short Form (SPSI-R:SF). Items evaluate real-world problem-solving attitudes and skills across 5 subscales: Positive Problem Orientation (PPO), Negative Problem Orientation (NPO), Rational Problem Solving (RPS), Impulsivity/Carelessness Style (ICS), and Avoidance Style (AS). Items are scored on a 5-point Likert scale (0 = "Not at all true of me" to 4 = "Extremely true of me"). Standardized total scores range from 0 to 20 (or converted standard scores with a mean of 100, SD = 15), with higher total scores reflecting more constructive and effective social problem-solving abilities.

    Time frame: Baseline and 12-weeks post-enrollment

11. Change in Child Symptom Experience (Memorial Symptom Assessment Scale)

    Assessed using the Memorial Symptom Assessment Scale (MSAS) parent-proxy scale (20 items). Evaluates the frequency, severity, and distress associated with common physical and psychological symptoms. Symptom items are scored on multi-point Likert scales to yield subscale scores and a Total MSAS Score ranging from 0 to 100, where higher scores represent greater symptom frequency, severity, and distress.

    Time frame: Baseline to 12-weeks post-enrollment

Other outcomes

1. Change in child acute health care utilization

   Assessed using electronic health record (EHR)-extracted healthcare utilization count data. We will track the total count of acute and routine healthcare service encounters, including emergency department (ED) visits, inpatient hospital admissions, and outpatient clinic appointments. Comparison evaluates the difference in encounter counts per participant between the 3-month pre-enrollment period and the 3-month post-enrollment period.

   Time frame: 3 months prior to study enrollment and 3 months post-enrollment

Individual participant data

Plan to share: Yes — All de-identified individual participant data, along with the study protocol and statistical analysis plan, will be available to qualified researchers upon reasonable request and creation of a data sharing agreement. Data will be made available following the publication of primary study results.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Beginning 3 months after publication of results and up to 5 years after publication of results.

Access criteria: Access to de-identified participant data, study protocol, and statistical analysis plan will be granted to scientific researchers who provide a methodologically sound research proposal. Requests must be sent to the Principal Investigator for review and approval. Data release is contingent upon creation of a formal data sharing agreement (DSA) to ensure participant confidentiality and data security.