Pediatric Mental Health ServicesPAQNCT06838689
Participatory Approaches to Qualitative Research (PAQ): Comparing Two Approaches to Patient, Public and Clinician Involvement in Qualitative Research
A study of Pediatric Mental Health Services and Cancer Screening, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
The goal of this trial is to compare two types of patient, public and clinician involvement (PPCI) in research: Consultative PPCI and Collaborative PPCI. The study team will compare these methods of PPCI in a randomized clinical trial (RCT) in which PPCI participants will engage with research teams on one of three… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pediatric Mental Health Services, Cancer Screening, Serious Illness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2025to 31 Oct 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years
- Can communicate in English
- Able to take part in research activities via a computer or a smartphone
- Patients, care partners, clinicians, other healthcare professionals, teachers and school staff, health policy experts, and community members
- Has lived experience or professional expertise relating to pediatric mental health
- Adults aged ≥21 years
Show all 15Show fewer
- Can communicate in English
- Able to take part in research activities via a computer or a smartphone
- Patients, care partners, clinicians, other healthcare professionals, health policy experts, and community members
- Is eligible for population-based cancer screening tests (breast, prostate, cervical, colorectal cancer), or has lived experience or professional expertise relating to generalized cancer screening
- Adults aged ≥18 years
- Can communicate in English
- Able to take part in research activities via a computer or a smartphone
- Patients, care partners, clinicians, other healthcare professionals, health policy experts, and community members
- Has lived experience or professional expertise relating to serious illness (defined as "a health condition that carries a high risk of mortality and either negatively impacts a person's daily functioning or quality of life or excessively strains his or her caregivers."
Who cannot join
- Children <18 years
- Cannot communicate in English
- Adults unable to provide verbal consent
- Prisoners
- Unable to take part in research activities via a computer or a smartphone
- Generalized cancer screening
Show all 18Show fewer
- Children <18 years
- Cannot communicate in English
- Adults unable to provide verbal consent
- Prisoners
- Unable to take part in research activities via a computer or a smartphone
- Serious illness experience
- Children <18 years
- Cannot communicate in English
- Adults unable to provide verbal consent
- Prisoners
- Unable to take part in research activities via a computer or a smartphone
- Note: We will not specifically exclude pregnant women, so they may be included incidentally.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Catherine Saunders, Assistant Professor of Medicine, PhD, MPH contact
United States2 sites, 2 recruiting
- Recruiting
Geisel School of Medicine at Dartmouth
Hanover, New Hampshire, 03755
603-650-5402
Christine M Gunn, PhD
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
603-650-5402
JoAnna K Leyenaar, MD, PhD, MPH
About this study
Official title: Participatory Approach to Qualitative Research (PAQ): Comparing Two Methods of Engaging Stakeholders in Qualitative Research
The goal of this trial is to compare two types of patient, public and clinician involvement (PPCI) in research: Consultative PPCI and Collaborative PPCI.
The study team will compare these methods of PPCI in a randomized clinical trial (RCT) in which PPCI participants will engage with research teams on one of three real qualitative research interview studies addressing topics: 1) pediatric mental health, 2) cancer screening and 3) serious illness. Qualitative interviews are conversations with people about their experiences and perspectives. In all three qualitative studies, PPCI participants will help us at every stage of the research, from design (making choices about how to set up the study) through dissemination (sharing findings).
The researchers do not know about any quantitative (numbers) evidence from RCTs about how well different PPCI approaches work. As far as the study team knows, this is the first RCT of PPCI approaches. Given this gap in knowledge, the research question is: How does a Consultative PPCI approach compare to a Collaborative PPCI approach in increasing engagement and partnership trust in research, particularly among historically underrepresented groups? The researchers' best guess (hypothesis), considering the information available, is that Collaborative PPCI will increase PPCI participant engagement, trust and the patient-centeredness of research more than Consultative PPCI.
Read the detailed description
This stratified randomized controlled clinical trial (RCT) is to test Consultative patient, public and clinician involvement (PPCI) in research against Collaborative PPCI in the context of three real-world qualitative research studies. Qualitative research methods can reveal insights into complex health phenomena, such as access to health services, clinician-patient communication, implementation research, and organizational culture and improvement. PPCI has also been acknowledged as indispensable in enhancing the validity, rigor and credibility of research.
The research team developed detailed guides for two approaches to PPCI throughout the lifetime of qualitative research projects, including 1) design, 2) data collection, 3) analysis and 4) dissemination. While there is a strong theoretical rationale that participatory research processes like Consultative PPCI may improve partner engagement more than consultative PPCI, evidence from experimental studies is lacking.
Given this gap, the research question is: How does a Consultative PPCI approach to involvement in research compared to a Collaborative PPCI approach in increasing engagement and partnership trust in research, particularly among historically underrepresented groups?
The study team hypothesizes Collaborative PPCI will result in higher partner-reported engagement, trust and patient-centeredness of research than Consultative PPCI.
Study Aims:
- To compare the effectiveness of Consultative PPCI versus Collaborative PPCI on partner engagement in research (primary outcome), partnership trust (secondary outcome).
- To use mixed methods to determine whether stakeholder engagement in research and partnership trust vary based on stakeholder characteristics.
- To evaluate the extent to which engagement and partnership trust are mediated by engagement experience and group dynamics.
The research team will conduct a randomized controlled trial (RCT) to test the relative effectiveness of these PPCI approaches across three real-world qualitative studies. Participants will be randomly assigned to Consultative or Collaborative PPCI using a stratified approach with three embedded qualitative studies as strata. The core function of Collaborative PPCI is to test a simple, collaborative partner engagement model, while the core function of Consultative PPCI is to test the traditional consultative partner engagement model. The researchers are are operationalizing Consultative PPCI with Community Advisory Boards (CAB) and Collaborative PPCI with a new approach called the Participatory Approach to Qualitative Research (PAQ). The study team selected an RCT with stratified randomization to evaluate the research question in the context of three diverse topic areas, to maintain separate Consultative and Collaborative study groups of reasonable size within each strata (n=10 for each study's CAB or PAQ group, for a total of 60 participants), and to ultimately increase generalizability of results. Following randomization, the researchers will evaluate for balance across groups in participant age, race, ethnicity, rurality and composite socioeconomic status (comprising education and income). The objectives, interventions and outcomes will be measured at the individual participant level. The RCT will be conducted over an 18-month period. The PAQ and CAB arms will have separate professional research staff facilitators, both experienced in CAB and PAQ facilitation; these facilitators will be involved in all three project strata. Prior to study start, the research team will standardize Consultative and Collaborative PPCI training.
- Being tested
- Comparison of two standard of care regimens
- Keywords
- Pediatric mental health, Serious illness in elderly patients, cancer screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of two standard of care regimensOther
Also called Comparison between the CAB and PAQ models of community engagement
Participatory Approaches to Qualitative Research (PAQ): Comparing Two Approaches to Patient, Public and Clinician Involvement (PPCI) in Qualitative Research: PAQ and CAB (Community Advisory Boards)
| Study group | Role | What they receive |
|---|---|---|
| Consultative PPCI Model via Community Advisory Boards (CAB) | Experimental | Community Advisory Board: a consultative model of engagement where participants attend 4 quarterly meetings with shared leadership between participants and research team. Receives: Other: Comparison of two standard of care regimens |
| Collaborative PPCI Model via the Participatory Approach to Qualitative | Experimental | Participatory Approach to Qualitative Research: a collaborative model of engagement with 4 idea coproduction sessions and a close partnership with study staff. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Engagement in Research scale (PEIRS-22)
Engagement in research, measured using the Patient Engagement in Research scale (PEIRS-22). Total score is 22-110, with higher scores reflecting greater engagement in research.
Measured: 18 months
Secondary outcomes (3)
Research Engagement Survey Tool (REST)
Partnership Trust, measured using the "build and maintain trust in the partnership" scale of the Research Engagement Survey Tool (REST). Component scores are calculated as means, with four being the best possible score.
Measured: 18 months
Patient and Public Involvement in Research Assessment Survey
Research patient-centeredness, measured using the Patient and Public Involvement in Research Assessment Survey (PAS). Possible scores range from 0-80, with higher scores equating to higher patient-centeredness.
Measured: 18 months
Person-Centeredness of Research Scale
Research patient centeredness, measured using the Person-Centeredness of Research Scale. Possible scores range from -14 to +14, with higher scores representing more patient-centered research.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Sep 2025
- Primary completion30 Aug 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Mental Health ServicesStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental Intervention 1: Consultative PPCI Model via Community Advisory Boards (CAB): Community Advisory Board: a consultative model of engagement where participants attend 4 quarterly meetings with shared leadership between participants and research team. Experimental Intervention 2: Collaborative PPCI Model via the Participatory Approach to Qualitative Research (PAQ) Participatory Approach to Qualitative Research: a collaborative model of engagement with 4 idea coproduction sessions and a close partnership with study staff.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Dartmouth College
- Responsible party
- Principal investigator, Catherine Hylas Saunders, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838689
- Sponsor's protocol ID
- PAQ_STUDY02002675_RCT
- Other IDs
- SOE-2023C3-25572
- Acronym
- PAQ
- Status last verified
- Nov 2025
- First submitted
- 19 Feb 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participatory Approach to Qualitative Research (PAQ): Comparing Two Methods of Engaging Stakeholders in Qualitative Research
- ClinicalTrials.gov ID
- NCT06838689
- Acronym / sponsor ID
- PAQ / PAQ_STUDY02002675_RCT
- Keywords
- Pediatric mental health, Serious illness in elderly patients, cancer screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Dartmouth College
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 21 Feb 2025 (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.
The goal of this trial is to compare two types of patient, public and clinician involvement (PPCI) in research: Consultative PPCI and Collaborative PPCI.
The study team will compare these methods of PPCI in a randomized clinical trial (RCT) in which PPCI participants will engage with research teams on one of three real qualitative research interview studies addressing topics: 1) pediatric mental health, 2) cancer screening and 3) serious illness. Qualitative interviews are conversations with people about their experiences and perspectives. In all three qualitative studies, PPCI participants will help us at every stage of the research, from design (making choices about how to set up the study) through dissemination (sharing findings).
The researchers do not know about any quantitative (numbers) evidence from RCTs about how well different PPCI approaches work. As far as the study team knows, this is the first RCT of PPCI approaches. Given this gap in knowledge, the research question is: How does a Consultative PPCI approach compare to a Collaborative PPCI approach in increasing engagement and partnership trust in research, particularly among historically underrepresented groups? The researchers' best guess (hypothesis), considering the information available, is that Collaborative PPCI will increase PPCI participant engagement, trust and the patient-centeredness of research more than Consultative PPCI.
Detailed description
This stratified randomized controlled clinical trial (RCT) is to test Consultative patient, public and clinician involvement (PPCI) in research against Collaborative PPCI in the context of three real-world qualitative research studies. Qualitative research methods can reveal insights into complex health phenomena, such as access to health services, clinician-patient communication, implementation research, and organizational culture and improvement. PPCI has also been acknowledged as indispensable in enhancing the validity, rigor and credibility of research.
The research team developed detailed guides for two approaches to PPCI throughout the lifetime of qualitative research projects, including 1) design, 2) data collection, 3) analysis and 4) dissemination. While there is a strong theoretical rationale that participatory research processes like Consultative PPCI may improve partner engagement more than consultative PPCI, evidence from experimental studies is lacking.
Given this gap, the research question is: How does a Consultative PPCI approach to involvement in research compared to a Collaborative PPCI approach in increasing engagement and partnership trust in research, particularly among historically underrepresented groups?
The study team hypothesizes Collaborative PPCI will result in higher partner-reported engagement, trust and patient-centeredness of research than Consultative PPCI.
Study Aims:
- To compare the effectiveness of Consultative PPCI versus Collaborative PPCI on partner engagement in research (primary outcome), partnership trust (secondary outcome).
- To use mixed methods to determine whether stakeholder engagement in research and partnership trust vary based on stakeholder characteristics.
- To evaluate the extent to which engagement and partnership trust are mediated by engagement experience and group dynamics.
The research team will conduct a randomized controlled trial (RCT) to test the relative effectiveness of these PPCI approaches across three real-world qualitative studies. Participants will be randomly assigned to Consultative or Collaborative PPCI using a stratified approach with three embedded qualitative studies as strata. The core function of Collaborative PPCI is to test a simple, collaborative partner engagement model, while the core function of Consultative PPCI is to test the traditional consultative partner engagement model. The researchers are are operationalizing Consultative PPCI with Community Advisory Boards (CAB) and Collaborative PPCI with a new approach called the Participatory Approach to Qualitative Research (PAQ). The study team selected an RCT with stratified randomization to evaluate the research question in the context of three diverse topic areas, to maintain separate Consultative and Collaborative study groups of reasonable size within each strata (n=10 for each study's CAB or PAQ group, for a total of 60 participants), and to ultimately increase generalizability of results. Following randomization, the researchers will evaluate for balance across groups in participant age, race, ethnicity, rurality and composite socioeconomic status (comprising education and income). The objectives, interventions and outcomes will be measured at the individual participant level. The RCT will be conducted over an 18-month period. The PAQ and CAB arms will have separate professional research staff facilitators, both experienced in CAB and PAQ facilitation; these facilitators will be involved in all three project strata. Prior to study start, the research team will standardize Consultative and Collaborative PPCI training.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental Intervention 1: Consultative PPCI Model via Community Advisory Boards (CAB): Community Advisory Board: a consultative model of engagement where participants attend 4 quarterly meetings with shared leadership between participants and research team. Experimental Intervention 2: Collaborative PPCI Model via the Participatory Approach to Qualitative Research (PAQ) Participatory Approach to Qualitative Research: a collaborative model of engagement with 4 idea coproduction sessions and a close partnership with study staff.
| Arm | Type | Receives |
|---|---|---|
| Consultative PPCI Model via Community Advisory Boards (CAB) | Experimental | Other: Comparison of two standard of care regimensCommunity Advisory Board: a consultative model of engagement where participants attend 4 quarterly meetings with shared leadership between participants and research team. |
| Collaborative PPCI Model via the Participatory Approach to Qualitative | Experimental | –Participatory Approach to Qualitative Research: a collaborative model of engagement with 4 idea coproduction sessions and a close partnership with study staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adults aged ≥18 years
- Can communicate in English
- Able to take part in research activities via a computer or a smartphone
- Patients, care partners, clinicians, other healthcare professionals, teachers and school staff, health policy experts, and community members
- Has lived experience or professional expertise relating to pediatric mental health
Key exclusion criteria (18 listed)
- Children <18 years
- Cannot communicate in English
- Adults unable to provide verbal consent
- Prisoners
- Unable to take part in research activities via a computer or a smartphone
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 |
|---|---|---|
| Comparison of two standard of care regimensAlso: Comparison between the CAB and PAQ models of community engagementParticipatory Approaches to Qualitative Research (PAQ): Comparing Two Approaches to Patient, Public and Clinician Involvement (PPCI) in Qualitative Research: PAQ and CAB (Community Advisory Boards) | Other | Consultative PPCI Model via Community Advisory Boards (CAB) |
Primary outcome
Patient Engagement in Research scale (PEIRS-22)
Time frame: 18 months
Engagement in research, measured using the Patient Engagement in Research scale (PEIRS-22). Total score is 22-110, with higher scores reflecting greater engagement in research.
3 secondary outcomes
Research Engagement Survey Tool (REST)
Time frame: 18 months
Patient and Public Involvement in Research Assessment Survey
Time frame: 18 months
Person-Centeredness of Research Scale
Time frame: 18 months
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 Nov 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Catherine Saunders, Assistant Professor of Medicine, PhD, MPH contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pediatric Mental Health Services and Cancer Screening, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
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 15 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Contact Catherine Saunders, Assistant Professor of Medicine, PhD, MPH (603-650-5402, Catherine.Hylas.Saunders@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Engagement in Research scale (PEIRS-22) (time frame: 18 months). 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 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.