Trial Outcomes & Findings for Resiliency Programming for Caregivers of Children With Learning and Attentional Difficulties (NCT NCT06492278)

NCT ID: NCT06492278

Last Updated: 2026-03-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

Approximately 3 months (8-10 weeks) post-enrollment

Results posted on

2026-03-12

Participant Flow

Participant milestones

Participant milestones
Measure
SMART-3RP
This is an adapted 8-session group program of the Relaxation Response Resiliency Program (3RP) for parents of children with LAD.
Health Education Program
This is an adapted 8-session group program to provide health behavior education.
Overall Study
STARTED
15
13
Overall Study
COMPLETED
15
13
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Resiliency Programming for Caregivers of Children With Learning and Attentional Difficulties

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
SMART-3RP
n=15 Participants
This is an adapted 8-session group program of the Relaxation Response Resiliency Program (3RP) for parents of children with LAD.
Health Education Program
n=13 Participants
This is an adapted 8-session group program to provide health behavior education.
Total
n=28 Participants
Total of all reporting groups
Age, Continuous
43.8 Years
STANDARD_DEVIATION 9.2 • n=9 Participants
41.1 Years
STANDARD_DEVIATION 5.6 • n=9 Participants
42.5 Years
STANDARD_DEVIATION 7.7 • n=18 Participants
Sex: Female, Male
Female
15 Participants
n=9 Participants
13 Participants
n=9 Participants
28 Participants
n=18 Participants
Sex: Female, Male
Male
0 Participants
n=9 Participants
0 Participants
n=9 Participants
0 Participants
n=18 Participants
Race/Ethnicity, Customized
Hispanic/Latino
7 Participants
n=9 Participants
8 Participants
n=9 Participants
15 Participants
n=18 Participants
Race/Ethnicity, Customized
Not Hispanic/Latino
8 Participants
n=9 Participants
5 Participants
n=9 Participants
13 Participants
n=18 Participants
Preferred Language
English
8 Participants
n=9 Participants
8 Participants
n=9 Participants
16 Participants
n=18 Participants
Preferred Language
Spanish
7 Participants
n=9 Participants
5 Participants
n=9 Participants
12 Participants
n=18 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All participants screened eligible to participate

Number of participants enrolled in the study, of those eligible

Outcome measures

Outcome measures
Measure
All Participants
n=35 Participants
Rate of enrollment was assessed prior to participant randomization to SMART or HEP groups.
Health Education Program
This is an adapted 8-session group program to provide health behavior education.
Feasibility of Study Enrollment
28 Participants

PRIMARY outcome

Timeframe: Approximately 3 months (approximately 8-10 weeks after intervention start)

Population: Please note that 25 participants (of 28 randomized) attended at least one group session and are thus included in analyses reported here.

Number of participants attending at least 6 of 8 group meetings (of those who attended at least 1 group session)

Outcome measures

Outcome measures
Measure
All Participants
n=14 Participants
Rate of enrollment was assessed prior to participant randomization to SMART or HEP groups.
Health Education Program
n=11 Participants
This is an adapted 8-session group program to provide health behavior education.
Feasibility of Intervention Attendance (% Attending at Least 6 of 8 Sessions)
11 Participants
5 Participants

PRIMARY outcome

Timeframe: Approximately 3 months (approximately 8-10 weeks after intervention start)

Population: Please note that 25 participants (of 28 randomized) attended at least one group session and are thus included in analyses reported here.

Number of participants attending at least 4 of 8 group meetings

Outcome measures

Outcome measures
Measure
All Participants
n=14 Participants
Rate of enrollment was assessed prior to participant randomization to SMART or HEP groups.
Health Education Program
n=11 Participants
This is an adapted 8-session group program to provide health behavior education.
Feasibility of Intervention Attendance (% Attending at Least 4 of 8 Sessions)
12 Participants
9 Participants

PRIMARY outcome

Timeframe: Approximately 3 months (8-10 weeks) post-enrollment

Population: This index includes participants who agreed to complete study surveys despite not attending group sessions (intent-to-treat analysis); as such, all 28 participants who were randomized to either SMART-3RP or HEP are included.

Number of participants providing follow-up surveys after group completion

Outcome measures

Outcome measures
Measure
All Participants
n=15 Participants
Rate of enrollment was assessed prior to participant randomization to SMART or HEP groups.
Health Education Program
n=13 Participants
This is an adapted 8-session group program to provide health behavior education.
Feasibility of Follow-up Survey Completion
14 Participants
11 Participants

PRIMARY outcome

Timeframe: Approximately 3 months (approximately 8-10 weeks after intervention start)

Population: Please note that 24 participants (of 28 randomized) attended at least one group session and have available data, and are thus included in analyses reported here.

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.

Outcome measures

Outcome measures
Measure
All Participants
n=13 Participants
Rate of enrollment was assessed prior to participant randomization to SMART or HEP groups.
Health Education Program
n=11 Participants
This is an adapted 8-session group program to provide health behavior education.
Acceptability of the Refined Intervention Content (SMART-3RP and HEP)
9 Participants
5 Participants

PRIMARY outcome

Timeframe: Approximately 3 months (8-10 weeks) post-enrollment

Population: Please note that 24 participants (of 28 randomized) attended at least one group session and have available data, and are thus included in analyses reported here.

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.

Outcome measures

Outcome measures
Measure
All Participants
n=13 Participants
Rate of enrollment was assessed prior to participant randomization to SMART or HEP groups.
Health Education Program
n=11 Participants
This is an adapted 8-session group program to provide health behavior education.
Acceptability of Number of Sessions
10 Participants
9 Participants

PRIMARY outcome

Timeframe: Approximately 3 months (8-10 weeks) post-enrollment

Population: Please note that 23 participants (of 28 randomized) attended at least one group session and have available data and are thus included in analyses reported here.

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.

Outcome measures

Outcome measures
Measure
All Participants
n=13 Participants
Rate of enrollment was assessed prior to participant randomization to SMART or HEP groups.
Health Education Program
n=10 Participants
This is an adapted 8-session group program to provide health behavior education.
Acceptability of Teleconferencing Delivery
9 Participants
8 Participants

PRIMARY outcome

Timeframe: Approximately 3 months (8-10 weeks) post-enrollment

Population: Please note that 24 participants (of 28 randomized) attended at least one group session and have available data, and are thus included in analyses reported here.

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.

Outcome measures

Outcome measures
Measure
All Participants
n=13 Participants
Rate of enrollment was assessed prior to participant randomization to SMART or HEP groups.
Health Education Program
n=11 Participants
This is an adapted 8-session group program to provide health behavior education.
Acceptability- Group Cohesiveness
11 Participants
11 Participants

Adverse Events

Health Education Program

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

SMART-3RP

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elyse Park, PhD MPH

Mass General Brigham

Phone: 617-724-6836

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place