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Based on findings from our prior trials with parents of children with learning and attentional disabilities and parents of children with autism spectrum disorder (Kuhlthau et al., 2020; Park et al., 2020; IRB approved: #:2016P001622 and 2016P002037 respectively), the investigators propose to pilot test and refine the adapted resiliency intervention (SMART-3RP) among fathers of children with special health care needs.
This is an open pilot study. Based on Phase I findings (IRB #2021P002838), the investigators propose to enroll up to 12 fathers (in 2 groups) of children and youth with special health care needs (CYSHCN) in the adapted SMART-3RP intervention. The SMART-3RP is an 8-session mind-body resiliency intervention that will be conducted virtually. Participants will complete the study survey at baseline and immediately following the intervention. As this is a pilot, participants will also be asked to provide weekly feedback on program sessions and participate in an exit interview following the intervention. The intervention may be iteratively modified as the investigators receive feedback from participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Pilot | Experimental | An adapted version of the Relaxation Response Resiliency Program (3RP) for fathers of CYSHCN. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relaxation Response Resiliency Program for Father of CYSHCN | Behavioral | Virtually delivered psycho-educational resiliency training program for fathers of CYSHCN |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feedback regarding adapted intervention acceptability by session | Likert ratings on post-session feedback surveys (0 to 5 with 5 more acceptable), qualitative responses from exit interviews | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (attendance at 6/8 sessions) | Feasibility will be assessed using attendance (i.e. 6/8 sessions). | 8 weeks |
| Feasibility (data collection number completing study surveys) | Feasibility will be assessed using number of dads completing study surveys |
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Inclusion Criteria:
Exclusion Criteria:
Self-reported identify as father or male guardian of at least one child with special health care needs (e.g., autism spectrum disorder, cerebral palsy, dyslexia)
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| Name | Affiliation | Role |
|---|---|---|
| Karen A Kuhlthau, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30900195 | Result | Kuhlthau KA, Luberto CM, Traeger L, Millstein RA, Perez GK, Lindly OJ, Chad-Friedman E, Proszynski J, Park ER. A Virtual Resiliency Intervention for Parents of Children with Autism: A Randomized Pilot Trial. J Autism Dev Disord. 2020 Jul;50(7):2513-2526. doi: 10.1007/s10803-019-03976-4. | |
| 34917419 | Result | Luberto CM, Perez GK, Finkelstein-Fox L, Millstein RA, Fell L, Chad-Friedman E, Park ER, Kuhlthau KA. Acceptability of a Virtual Mind-Body Intervention for Parents of Children With Autism or Learning Disabilities. Glob Adv Health Med. 2021 Dec 9;10:21649561211047804. doi: 10.1177/21649561211047804. eCollection 2021. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 4, 2022 | Sep 1, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 4, 2022 | Sep 1, 2022 | ICF_001.pdf |
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We ran two groups of a resiliency intervention.
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| 3 months |
| Acceptability helpfulness ratings of sessions and aspects of program | Acceptability will be assessed using a Participant Feedback questionnaire: questionnaire includes ratings of session helpfulness (1 to 5 with 1 being very helpful and 1 being not at all helpful), likert ratings of program aspects (number, length, etc of sessions), and open-ended qualitative feedback questions. | 3 months |
| 31650412 | Result | Park ER, Perez GK, Millstein RA, Luberto CM, Traeger L, Proszynski J, Chad-Friedman E, Kuhlthau KA. A Virtual Resiliency Intervention Promoting Resiliency for Parents of Children with Learning and Attentional Disabilities: A Randomized Pilot Trial. Matern Child Health J. 2020 Jan;24(1):39-53. doi: 10.1007/s10995-019-02815-3. |