ParentingSPARKNCT06492278
Resiliency Programming for Caregivers of Children With Learning and Attentional Difficulties
A study testing SMART-3RP and Health Education Program in people with Parenting and Stress, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a randomized open pilot trial enrolling up to 40 co-primary caregivers of children with LAD. Participants will be randomized to receive either mind-body resiliency group (SMART-LAD, intervention) or an evidence-based group intervention Health Education Program (HEP, control) which is a multiple behavior change… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parenting, Stress, Learning Disabilities, Child
- What is being tested?
- SMART-3RP and Health Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 17 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- English-speaking
- Age 18 or older
- Ability to participate in group, virtual sessions including access to computer, tablet, or smartphone, and internet
- Parents or guardians of a child (< age 18) with LAD.
Who cannot join
- Parents with significant psychiatric conditions (i.e., active suicidality or psychosis) or who are otherwise unable to participate, at the investigators' clinical discretion.
- Only one parent per family can participate.
- Unwilling or unable to participate in the study
- Considered medically or otherwise unable to participate by the study PI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Pilot Trial of a Resiliency Group Program for Caregivers of Children With Learning and Attentional Difficulties: Supporting Parents Raising Kids (SPARK)
This is a randomized open pilot trial enrolling up to 40 co-primary caregivers of children with LAD. Participants will be randomized to receive either mind-body resiliency group (SMART-LAD, intervention) or an evidence-based group intervention Health Education Program (HEP, control) which is a multiple behavior change program that addresses sleep, exercise, nutrition, substance use, and working with one's healthcare team. Both the SMART-3RP and HEP programs have been modified based on adaptions from our previous qualitative study.
Read the detailed description
The primary objective of this protocol is to conduct an open pilot to elicit initial quantitative and qualitative feedback regarding feasibility and acceptability of the interventions (SMART-3RP and HEP) that we have refined. Both groups are designed to improve well-being for caregivers experiencing stress-related to caring for a child with LAD.
The investigators will ask participants to complete approximately 15-minute survey batteries via REDCap at baseline and after the 8-week program, including assessments of intervention feasibility and acceptability as well as psychosocial outcomes. To inform plans for ongoing program refinement, the investigators will also elicit specific feedback regarding study assessment tools, recruitment procedures, and group composition.
Results will be used to inform a larger randomized trial.
- Being tested
- SMART-3RP, Health Education Program
- Keywords
- Resiliency training, Stress management, Learning and attentional disabilities
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART-3RPBehavioural
The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
Health Education ProgramBehavioural
This is a multiple behavior change program that addresses sleep, exercise, nutrition, substance use, and working with one's healthcare team.
| Study group | Role | What they receive |
|---|---|---|
| SMART-3RP | Experimental | This is an adapted 8-session group program of the Relaxation Response Resiliency Program (3RP) for parents of children with LAD. Receives: Behavioral: SMART-3RP |
| Health Education Program | Active comparator | This is an adapted 8-session group program to provide health behavior education. Receives: Behavioral: Health Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Study Enrollment
Number of participants enrolled in the study, of those eligible
Measured: Baseline
Feasibility of Intervention Attendance (% Attending at Least 6 of 8 Sessions)
Number of participants attending at least 6 of 8 group meetings (of those who attended at least 1 group session)
Measured: Approximately 3 months (approximately 8-10 weeks after intervention start)
Feasibility of Intervention Attendance (% Attending at Least 4 of 8 Sessions)
Number of participants attending at least 4 of 8 group meetings
Measured: Approximately 3 months (approximately 8-10 weeks after intervention start)
Feasibility of Follow-up Survey Completion
Number of participants providing follow-up surveys after group completion
Measured: Approximately 3 months (8-10 weeks) post-enrollment
Acceptability of the Refined Intervention Content (SMART-3RP and HEP)
Number of participants rating satisfaction with intervention content as high (at least 4 on a Likert scale of 1-5), of those who attended at least one program session.
Measured: Approximately 3 months (approximately 8-10 weeks after intervention start)
Acceptability of Number of Sessions
Number of participants rating satisfaction with number of sessions as high (at least 4 on a Likert scale of 1-5), of those completing at least one group session.
Measured: Approximately 3 months (8-10 weeks) post-enrollment
Acceptability of Teleconferencing Delivery
Number of participants rating satisfaction with teleconferencing as high (at least 4 on a Likert scale of 1-5), of those who completed at least one program session.
Measured: Approximately 3 months (8-10 weeks) post-enrollment
Acceptability- Group Cohesiveness
Number of participants rating agreement with within-group trust as high (at least 4 on a Likert scale of 1-5), of those who completed at least one program session.
Measured: Approximately 3 months (8-10 weeks) post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Nov 2024
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Elyse Park, PhD, Massachusetts General Hospital
- Investigators
- Elyse R Park, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492278
- Sponsor's protocol ID
- 2024P001219
- Other IDs
- 1R56AT011869-01A1
- Acronym
- SPARK
- Status last verified
- Feb 2026
- First submitted
- 27 Jun 2024
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park ER, Goshe BM, Miranda I, Finkelstein-Fox L, Nourse P, Williams R, Nicolosi G, Lopez K, de la Cruz R, Barreto E, Millstein RA, Perez GK, Mahaffey B, Abuelo C, Winklosky B, Rippey R, Kuhlthau KA. Feasibility and Acceptability of Group-Based Interventions (Offered in English and Spanish) for Caregivers of Children With LAD. Glob Adv Integr Med Health. 2026 May 8;15:27536130261442880. doi: 10.1177/27536130261442880. eCollection 2026 Jan-Dec.
PubMed 42137451
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Pilot Trial of a Resiliency Group Program for Caregivers of Children With Learning and Attentional Difficulties: Supporting Parents Raising Kids (SPARK)
- ClinicalTrials.gov ID
- NCT06492278
- Acronym / sponsor ID
- SPARK / 2024P001219
- Keywords
- Resiliency training, Stress management, Learning and attentional disabilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Posted 12 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized open pilot trial enrolling up to 40 co-primary caregivers of children with LAD. Participants will be randomized to receive either mind-body resiliency group (SMART-LAD, intervention) or an evidence-based group intervention Health Education Program (HEP, control) which is a multiple behavior change program that addresses sleep, exercise, nutrition, substance use, and working with one's healthcare team. Both the SMART-3RP and HEP programs have been modified based on adaptions from our previous qualitative study.
Detailed description
The primary objective of this protocol is to conduct an open pilot to elicit initial quantitative and qualitative feedback regarding feasibility and acceptability of the interventions (SMART-3RP and HEP) that we have refined. Both groups are designed to improve well-being for caregivers experiencing stress-related to caring for a child with LAD.
The investigators will ask participants to complete approximately 15-minute survey batteries via REDCap at baseline and after the 8-week program, including assessments of intervention feasibility and acceptability as well as psychosocial outcomes. To inform plans for ongoing program refinement, the investigators will also elicit specific feedback regarding study assessment tools, recruitment procedures, and group composition.
Results will be used to inform a larger randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART-3RP | Experimental | Behavioral: SMART-3RPThis is an adapted 8-session group program of the Relaxation Response Resiliency Program (3RP) for parents of children with LAD. |
| Health Education Program | Active comparator | Behavioral: Health Education ProgramThis is an adapted 8-session group program to provide health behavior education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking
- Age 18 or older
- Ability to participate in group, virtual sessions including access to computer, tablet, or smartphone, and internet
- Parents or guardians of a child (< age 18) with LAD.
Key exclusion criteria (4 listed)
- Parents with significant psychiatric conditions (i.e., active suicidality or psychosis) or who are otherwise unable to participate, at the investigators' clinical discretion.
- Only one parent per family can participate.
- Unwilling or unable to participate in the study
- Considered medically or otherwise unable to participate by the study PI
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 |
|---|---|---|
| SMART-3RPThe adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies. | Behavioural | SMART-3RP |
| Health Education ProgramThis is a multiple behavior change program that addresses sleep, exercise, nutrition, substance use, and working with one's healthcare team. | Behavioural | Health Education Program |
Primary outcome
Feasibility of Study Enrollment
Time frame: Baseline
Number of participants enrolled in the study, of those eligible
Feasibility of Intervention Attendance (% Attending at Least 6 of 8 Sessions)
Time frame: Approximately 3 months (approximately 8-10 weeks after intervention start)
Number of participants attending at least 6 of 8 group meetings (of those who attended at least 1 group session)
Feasibility of Intervention Attendance (% Attending at Least 4 of 8 Sessions)
Time frame: Approximately 3 months (approximately 8-10 weeks after intervention start)
Number of participants attending at least 4 of 8 group meetings
Feasibility of Follow-up Survey Completion
Time frame: Approximately 3 months (8-10 weeks) post-enrollment
Number of participants providing follow-up surveys after group completion
Acceptability of the Refined Intervention Content (SMART-3RP and HEP)
Time frame: Approximately 3 months (approximately 8-10 weeks after intervention start)
Number of participants rating satisfaction with intervention content as high (at least 4 on a Likert scale of 1-5), of those who attended at least one program session.
Acceptability of Number of Sessions
Time frame: Approximately 3 months (8-10 weeks) post-enrollment
Number of participants rating satisfaction with number of sessions as high (at least 4 on a Likert scale of 1-5), of those completing at least one group session.
Acceptability of Teleconferencing Delivery
Time frame: Approximately 3 months (8-10 weeks) post-enrollment
Number of participants rating satisfaction with teleconferencing as high (at least 4 on a Likert scale of 1-5), of those who completed at least one program session.
Acceptability- Group Cohesiveness
Time frame: Approximately 3 months (8-10 weeks) post-enrollment
Number of participants rating agreement with within-group trust as high (at least 4 on a Likert scale of 1-5), of those who completed at least one program session.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42137451Park ER, Goshe BM, Miranda I, Finkelstein-Fox L, Nourse P, Williams R, Nicolosi G, Lopez K, de la Cruz R, Barreto E, Millstein RA, Perez GK, Mahaffey B, Abuelo C, Winklosky B, Rippey R, Kuhlthau KA. Feasibility and Acceptability of Group-Based Interventions (Offered in English and Spanish) for Caregivers of Children With LAD. Glob Adv Integr Med Health. 2026 May 8;15:27536130261442880. doi: 10.1177/27536130261442880. eCollection 2026 Jan-Dec.
- 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. This study is not recruiting at the moment.
Elyse R Park, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART-3RP and Health Education Program in people with Parenting and Stress, run by Massachusetts General Hospital at 1 site 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 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: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 12 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Study Enrollment (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06492278, which also lists 1 linked publication.
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 12 Mar 2026.