TY - JOUR
T1 - Moving 2 Mindful (M2M) study protocol
T2 - Testing a mindfulness group plus ecological momentary intervention to decrease stress and anxiety in adolescents from high-conflict homes with a mixed-method longitudinal design
AU - Lucas-Thompson, Rachel
AU - Seiter, Natasha
AU - Broderick, Patricia C.
AU - Coatsworth, James Douglas
AU - Henry, Kimberly L.
AU - McKernan, Charlotte J.
AU - Smyth, Joshua M.
N1 - Funding Information:
We believe that this study is innovative, unique and important. The proposed study is significant because it will provide critical new information about the efficacy of directly targeting adolescents from high-conflict homes with an innovative mindfulness-based intervention to decrease stress and anxiety. This study will develop an intervention model for adolescents from high-conflict homes, but we believe this intervention model may eventually be applied more broadly to adolescents dealing with chronic environmental stressors. To support this effort, the current study will fill gaps in knowledge about within-person links between mindfulness, stress and anxiety. This study is innovative, as it seeks to shift the emphasis from intervening solely to improve marital relationships to also improving adolescent regulatory capabilities. This represents a test of a unique theoretical question (does a mindfulness intervention improve adolescent functioning in the context of marital conflict?) as well as employing a novel approach (incorporating a multimethod adaptive intervention into a mindfulness intervention). At the completion of this study, we expect to have generated evidence for a feasible and acceptable mindfulness plus multimethod adaptive programme that likely produces meaningful reductions in stress and anxiety. We plan to build on the results by preparing a larger-scale efficacy trial of L2B Plus for improving outcomes in adolescents from high-conflict homes. Contributors All authors were involved with study design. RLT and NS wrote the initial draft of the protocol. PCB, JDC, KLH, CJM and JMS read and revised the protocol. All authors approve the publication of this manuscript. A data safety and monitoring committee will be designated, which will review progress reports, including patient recruitment, retention/attrition and adverse experiences. This committee is independent from the sponsor. Protocol amendments will be reviewed by this committee as well as the sponsor and the Institutional Review Board at Colorado State University. Funding This work was supported by the National Center for Complementary and Integrative Health (Award Number K01AT009592-01; PI, Lucas-Thompson). Publication of this article was supported by the Colorado State University Libraries Open Access Research and Scholarship Fund. Disclaimer All study documents and information will be stored securely and identified with an identification number to protect participant confidentiality. Participants’ study-specific information will not be released to those outside the study team without written permission from the participant. Competing interests None declared. Patient consent for publication Not required. Ethics approval Colorado State University. Provenance and peer review Not commissioned; externally peer reviewed.
Funding Information:
This work was supported by the National Center for Complementary and Integrative Health (Award Number K01AT009592-01; PI, Lucas-Thompson). Publication of this article was supported by the Colorado State University Libraries Open Access Research and Scholarship Fund.
PY - 2019/11/1
Y1 - 2019/11/1
N2 - Introduction Interparental conflict exposure places adolescents at risk for problems with stress and anxiety; existing prevention/intervention strategies focus on reducing interparental conflict. Mindfulness-based programmes may be a promising treatment strategy for this population, but studies have not yet tested whether they are effective in this high-conflict context. In addition, evidence suggests that extensions to traditional treatments, such as delivering components in daily life that are tailored to moments of need, can increase treatment efficacy, particularly when combined with in-person treatments and particularly for adolescents. However, there are no such extensions to mindfulness interventions available. The Moving 2 Mindful study aims to (1) develop an ecological momentary intervention (EMI) supplement to Learning to BREATHE (L2B), an evidence-based mindfulness intervention for adolescents; (2) refine the EMI programme and determine the best delivery plan; (3) examine the feasibility and acceptability of L2B Plus (L2B plus the developed supplement) and (4) examine the potential for L2B Plus to reduce stress and anxiety for adolescents from high-conflict homes. Methods and analysis The Moving 2 Mindful study proposes a mixed-methods approach to developing and refining a multimethod adaptive supplement to L2B. Feasibility, acceptability and potential effectiveness will be tested in a sample of 38 families, who will be randomly assigned to receive L2B Plus or an active health and wellness control condition and followed until 3 months postintervention. A range of psychosocial and physiological factors will be assessed at multiple time points. This study is registered with clinicaltrials.gov (ID NCT03869749; pre-results). Ethics and dissemination The Institutional Review Board at Colorado State University has approved this study. Findings will be disseminated in scientific journals and conferences, whether they are positive, negative or inconclusive.
AB - Introduction Interparental conflict exposure places adolescents at risk for problems with stress and anxiety; existing prevention/intervention strategies focus on reducing interparental conflict. Mindfulness-based programmes may be a promising treatment strategy for this population, but studies have not yet tested whether they are effective in this high-conflict context. In addition, evidence suggests that extensions to traditional treatments, such as delivering components in daily life that are tailored to moments of need, can increase treatment efficacy, particularly when combined with in-person treatments and particularly for adolescents. However, there are no such extensions to mindfulness interventions available. The Moving 2 Mindful study aims to (1) develop an ecological momentary intervention (EMI) supplement to Learning to BREATHE (L2B), an evidence-based mindfulness intervention for adolescents; (2) refine the EMI programme and determine the best delivery plan; (3) examine the feasibility and acceptability of L2B Plus (L2B plus the developed supplement) and (4) examine the potential for L2B Plus to reduce stress and anxiety for adolescents from high-conflict homes. Methods and analysis The Moving 2 Mindful study proposes a mixed-methods approach to developing and refining a multimethod adaptive supplement to L2B. Feasibility, acceptability and potential effectiveness will be tested in a sample of 38 families, who will be randomly assigned to receive L2B Plus or an active health and wellness control condition and followed until 3 months postintervention. A range of psychosocial and physiological factors will be assessed at multiple time points. This study is registered with clinicaltrials.gov (ID NCT03869749; pre-results). Ethics and dissemination The Institutional Review Board at Colorado State University has approved this study. Findings will be disseminated in scientific journals and conferences, whether they are positive, negative or inconclusive.
UR - http://www.scopus.com/inward/record.url?scp=85075782906&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85075782906&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2019-030948
DO - 10.1136/bmjopen-2019-030948
M3 - Article
C2 - 31784436
AN - SCOPUS:85075782906
VL - 9
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 11
M1 - e030948
ER -