Children With Medical Complexity (CMC)Phase 2NCT07774663
Legacy Photo-narrative Study
A Phase 2 study testing Photo-narratives in people with Children With Medical Complexity (CMC) and Family Caregivers, run by Seattle Children's Hospital.
Trial summary
Children with medical complexity (CMC) live full meaningful lives that are often short. CMC and their families experience substantial distress, poor mental health, and low emotional well-being. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Children With Medical Complexity (CMC), Family Caregivers
- What is being tested?
- Photo-narratives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2027to 15 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- has a child who receives care at one of the study sites for a complex medical condition and is followed by the complex care and/or palliative care team
- has a child who is ages 3 months through 25 years old
- has a child who has previously been home/discharged
- has a child whose life expectancy of >6 months
Who cannot join
- are not the child's identified parent/legally authorized representative
- has a preferred language of care other than English or Spanish
- has an active psychiatric or chronic health concerns that preclude research participation
- has active child protective services involvement
About this study
Official title: Photo-narratives as a Legacy Intervention for Children With Medical Complexity and Their Families
Children with medical complexity (CMC) live full meaningful lives that are often short. CMC and their families experience substantial distress, poor mental health, and low emotional well-being. Existing research and our prior studies suggest that legacy, defined as the summation of qualities and experiences that form the child's enduring presence, can be a resource for actionable appraisal of and coping with stressful life experiences. Photo-narratives are a novel intervention that facilitate family sharing of images to tell stories about everyday experiences related to their child's quality-of-life and personhood. In our prior studies, families reported that photo-narratives were a simple, easy way to meaningfully connect and had the potential to be an important part of their child's legacy. What remains poorly understood, however, is how photo-narratives might impact family-centered outcomes. This study aims to and evaluate the feasibility, acceptability, and potential impact of photo-narratives in a pilot randomized controlled trial.
- Being tested
- Photo-narratives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photo-narrativesBehavioural
Photo-narratives are created by patients/families and include a series of captioned photos focused on who is important in their family, information about their quality of life, and their strengths. The narrative is accompanied by clinician prompts to facilitate patient/family-clinician discussion and engagement.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care control |
| Photo-narratives | Experimental | Not described Receives: Behavioral: Photo-narratives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
percent enrolled (enrolled parents/total approached) and percent completion (parents completing intervention/total randomized to the intervention)
Measured: From first enrollment to end of intervention completion at about 2 years
Acceptability
Percentage of intervention parents likely or very likely to recommend the intervention to other parents out of total randomized to the intervention
Measured: From first enrollment to end of intervention completion at about 2 years
Secondary outcomes (3)
Meaning and purpose
NIH PROMIS Meaning and Purpose Scale
Measured: 1- and 3-months post-enrollment
Hope
State Hope Scale
Measured: 1- and 3-months post-enrollment
Therapeutic alliance
Human Connection Scale
Measured: 1- and 3-months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Jun 2027 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Medical Complexity (CMC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Monroe Carell Jr. Children's Hospital at Vanderbilt
- Responsible party
- Principal investigator, Jori Bogetz, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774663
- Sponsor's protocol ID
- STUDY00005985
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photo-narratives as a Legacy Intervention for Children With Medical Complexity and Their Families
- ClinicalTrials.gov ID
- NCT07774663
- Acronym / sponsor ID
- STUDY00005985
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Monroe Carell Jr. Children's Hospital at Vanderbilt
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children with medical complexity (CMC) live full meaningful lives that are often short. CMC and their families experience substantial distress, poor mental health, and low emotional well-being. Existing research and our prior studies suggest that legacy, defined as the summation of qualities and experiences that form the child's enduring presence, can be a resource for actionable appraisal of and coping with stressful life experiences. Photo-narratives are a novel intervention that facilitate family sharing of images to tell stories about everyday experiences related to their child's quality-of-life and personhood. In our prior studies, families reported that photo-narratives were a simple, easy way to meaningfully connect and had the potential to be an important part of their child's legacy. What remains poorly understood, however, is how photo-narratives might impact family-centered outcomes. This study aims to and evaluate the feasibility, acceptability, and potential impact of photo-narratives in a pilot randomized controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care control |
| Photo-narratives | Experimental | Behavioral: Photo-narratives |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- has a child who receives care at one of the study sites for a complex medical condition and is followed by the complex care and/or palliative care team
- has a child who is ages 3 months through 25 years old
- has a child who has previously been home/discharged
- has a child whose life expectancy of >6 months
Key exclusion criteria (4 listed)
- are not the child's identified parent/legally authorized representative
- has a preferred language of care other than English or Spanish
- has an active psychiatric or chronic health concerns that preclude research participation
- has active child protective services involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photo-narrativesPhoto-narratives are created by patients/families and include a series of captioned photos focused on who is important in their family, information about their quality of life, and their strengths. The narrative is accompanied by clinician prompts to facilitate patient/family-clinician discussion and engagement. | Behavioural | Photo-narratives |
Primary outcome
Feasibility
Time frame: From first enrollment to end of intervention completion at about 2 years
percent enrolled (enrolled parents/total approached) and percent completion (parents completing intervention/total randomized to the intervention)
Acceptability
Time frame: From first enrollment to end of intervention completion at about 2 years
Percentage of intervention parents likely or very likely to recommend the intervention to other parents out of total randomized to the intervention
3 secondary outcomes
Meaning and purpose
Time frame: 1- and 3-months post-enrollment
Hope
Time frame: 1- and 3-months post-enrollment
Therapeutic alliance
Time frame: 1- and 3-months post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
Related trials for Children With Medical Complexity (CMC)
Not yet recruiting
Pilot Trial of a Meaning And Problem-Solving (MAPS) Intervention for Family Caregivers of Children With Medical Complexity
Family Caregivers, Children With Medical Complexity (CMC)
Recruiting
Nurse-led Integrated Home Service to Support Parents in Symptom Management for Children Requiring Respiratory Support
Children With Medical Complexity (CMC), Symptom Management
Not yet recruiting
Sibling Caregiver CMC Pilot Study
Children With Medical Complexity (CMC), Siblings
Recruiting
Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis
Children With Medical Complexity (CMC), Multiple Chronic Conditions
Recruiting
A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity
Children With Medical Complexity (CMC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Photo-narratives in people with Children With Medical Complexity (CMC) and Family Caregivers, run by Seattle Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: From first enrollment to end of intervention completion at about 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.