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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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

603-650-5402

Catherine.Hylas.Saunders@dartmouth.edu

United States2 sites, 2 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

    Recruiting

Other trials in United States

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:

  1. To compare the effectiveness of Consultative PPCI versus Collaborative PPCI on partner engagement in research (primary outcome), partnership trust (secondary outcome).
  2. To use mixed methods to determine whether stakeholder engagement in research and partnership trust vary based on stakeholder characteristics.
  3. 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 groups in NCT06838689
Study groupRoleWhat they receive
Consultative PPCI Model via Community Advisory Boards (CAB)ExperimentalCommunity 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 QualitativeExperimentalParticipatory 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted21 Feb 2025
  2. Study start1 Sep 2025
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

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)
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

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.

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