NCT01981070

Brief Summary

The purpose of this study is to evaluate the impact of two community based interventions for parents of adults with intellectual or developmental disabilities (IDD) who are requesting services. The two interventions will include:

  1. 1.Support and Information Intervention - provides parents with support and information about services for their sons and daughters
  2. 2.Mindfulness Intervention - empowers parents through teaching them mindfulness skills
  3. 3.Parents in both types of interventions will report benefits (reductions in psychological distress) maintained at follow-up.
  4. 4.Parents in mindfulness intervention group will report improvements in mindful parenting, self compassion, positive gain, empowerment, and reduced burden. Parents in support and information intervention group will report improvements in empowerment, positive gain, and reduced burden.
  5. 5.Parents in mindfulness intervention group will show greater improvements by 3 months follow-up than parents in the support and information group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

June 7, 2016

Status Verified

June 1, 2016

Enrollment Period

1.7 years

First QC Date

October 24, 2013

Last Update Submit

June 6, 2016

Conditions

Keywords

parent supportmindfulnessintellectual disabilitydevelopmental disabilityempowermentpsychological acceptanceparental stressparental depression

Outcome Measures

Primary Outcomes (1)

  • Depression Stress Anxiety Scale

    The Depression, Anxiety and Stress Scale (DASS; Lovibond \& Lovibond, 1995) is a 21-item scale assessing the severity of a range of symptoms across depression, anxiety, and stress. Parents will be asked to rate each item (statement) on a 4-point Likert scale, with 0 being "did not apply to me at all" and 3 being "applied to me very much, or most of the time." Only two subscales, 7-items each, will be used: depression and stress. The DASS generates a total score for each of the two subscales.

    21 weeks following Randomization

Secondary Outcomes (7)

  • Family Empowerment Scale

    21 weeks following Randomization

  • Five Facet Mindfulness Questionnaire-Short Form

    21 weeks following Randomization

  • Bangor Mindful Parenting Scale

    21 weeks following Randomization

  • Self-Compassion Scale-Short Form

    21 weeks following Randomization

  • Positive Gains Scale

    21 weeks following Randomization

  • +2 more secondary outcomes

Study Arms (2)

Mindfulness Intervention for Parents

OTHER

The mindfulness intervention program incorporates the same structure as the Support and Information for Parents intervention (orientation session, six 2-hour sessions over 6 weeks, co-facilitated by two leaders) but different content. Instead of presentations by experts and open-ended discussions and peer support, sessions will offer experiential training in meditation practice (sitting meditation, gentle yoga, and walking meditation), as outlined in the MBCT Program (Segal et al., 2012). Each week, parents will be required to practice a mindfulness skill, and also participate in a "mindful parenting" exercise as homework, such as joining their child in an activity of the child's choice.

Behavioral: Mindfulness Intervention for Parents

Support and Information for Parents

ACTIVE COMPARATOR

This 6-week program includes orientation session, six 2-hour sessions, held weekly. Parents will be provided with information on existing services in the region, and strategies to be strong advocates and plan and access services for their child. Each session will include a presentation by an expert, with a question answer period, a break, and facilitated discussion with other parents. The sessions will be co-facilitated by clinicians from the Disability Services Ontario (DSO) and Centre for Addiction and Mental Health (CAMH).

Behavioral: Support and Information for Parents

Interventions

See Study Arms

Mindfulness Intervention for Parents

See Study Arms

Support and Information for Parents

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parent applied to Disability Services Ontario (DSO) Toronto Region for services for their adult child
  • Adult child determined eligible for services but not yet completed the standardized assessment of need
  • Child age 17.5 and up and living at home
  • Parent proficient in English

You may not qualify if:

  • Parent has not applied for DSO Toronto Region for services for their adult child
  • Adult child determined ineligible for services
  • Child age under 17.5 or not living at home
  • Parent not proficient in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAMH

Toronto, Ontario, M5V 2B4, Canada

Location

Related Publications (22)

  • Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.

    PMID: 16443717BACKGROUND
  • Blackledge, J.T., & Hayes, S.C.. Using acceptance and commitment training in the support of parents of children diagnosed with autism. Child and Behaviour Therapy, 28, 1-18, 2006.

    BACKGROUND
  • Bohlmeijer E, ten Klooster PM, Fledderus M, Veehof M, Baer R. Psychometric properties of the five facet mindfulness questionnaire in depressed adults and development of a short form. Assessment. 2011 Sep;18(3):308-20. doi: 10.1177/1073191111408231. Epub 2011 May 17.

    PMID: 21586480BACKGROUND
  • Carlson LE, Ursuliak Z, Goodey E, Angen M, Speca M. The effects of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients: 6-month follow-up. Support Care Cancer. 2001 Mar;9(2):112-23. doi: 10.1007/s005200000206.

    PMID: 11305069BACKGROUND
  • Duncan LG, Coatsworth JD, Greenberg MT. A model of mindful parenting: implications for parent-child relationships and prevention research. Clin Child Fam Psychol Rev. 2009 Sep;12(3):255-70. doi: 10.1007/s10567-009-0046-3.

    PMID: 19412664BACKGROUND
  • Dykens, E. (2012, July). Mindfulness-Based Stress Reduction: Overall Findings from the Parent-Stress Intervention Project (PSIP). Paper presented at 2012 IASSID World Congress, Halifax, Nova Scotia.

    BACKGROUND
  • Epstein-Lubow, G., McBee, L., Darling, E., Armey, M., & Miller, M.. A pilot investigation of mindfulness-based stress reduction for caregivers of frail elderly. Mindfulness,2(2),95-102, 2011.

    BACKGROUND
  • Ferraioli, S. J., & Harris, S. L.. Comparative effects of mindfulness and skills-based parent training programs for parents of children with autism: feasibility and preliminary outcome data. Mindfulness, 1-13, 2013.

    BACKGROUND
  • Gutierrez, L. M.. Beyond coping: An empowerment perspective on stressful life events. Journal of Sociology & Social Welfare, 21: 201-219, 1994.

    BACKGROUND
  • Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.

    PMID: 16300724BACKGROUND
  • Jones L, Hastings RP, Totsika V, Keane L, Rhule N. Child behavior problems and parental well-being in families of children with autism: the mediating role of mindfulness and acceptance. Am J Intellect Dev Disabil. 2014 Mar;119(2):171-85. doi: 10.1352/1944-7558-119.2.171.

    PMID: 24679352BACKGROUND
  • Kabat-Zinn, J.. Mindfulness-Based Interventions in Context: Past, Present, and Future. Clinical Psychology: Science and Practice, 10(2): 144-156, 2003.

    BACKGROUND
  • Koren, P., Dechillo, N., & Friesen, B.. Measuring empowerment in families whose children have emotional disabilities: A brief questionnaire. Rehabilitation Psychology, 37(4): 305-321, 1992.

    BACKGROUND
  • Lawton MP, Moss M, Hoffman C, Perkinson M. Two transitions in daughters' caregiving careers. Gerontologist. 2000 Aug;40(4):437-48. doi: 10.1093/geront/40.4.437.

    PMID: 10961033BACKGROUND
  • Lovibond, S. H., & Lovibond, P. F.. Manual for the Depression Anxiety Stress Scales. Sydney: Psychology Foundation, 1995.

    BACKGROUND
  • Lunsky, Y., Tint, A., Robinson, S., Vickar, M., Ouelette-Kuntz, H.. System-wide information about family caregivers of adults with intellectual/developmental disabilities - a scoping review of the literature. Journal of Policy and Practice in Intellectual Disabilities. Submitted.

    BACKGROUND
  • Neece, C.. Mindfulness-Based Stress Reduction for Parents of Children with Developmental Delays: A Pilot Study. Paper presented at 2012 IASSID World Congress, Halifax, Nova Scotia. 2012, July.

    BACKGROUND
  • Pit-ten Cate, I.. Positive gain in mothers of children with physical disabilities. Unpublished Doctoral Dissertation, University of Southampton, UK, 2003.

    BACKGROUND
  • Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.

    PMID: 21584907BACKGROUND
  • Singh, N. N., Lancioni, G. E., Winton, A. S. W., Fisher, B. C., Wahler, R. G., McAleavey, K., Singh, J. & Sabaawi, M.. Mindful parenting decreases aggression, noncompliance, and self-injury in children with autism. Journal of Emotional and Behavioral Disorders, 14: 169-177, 2006.

    BACKGROUND
  • Singh NN, Lancioni GE, Winton AS, Singh J, Curtis WJ, Wahler RG, McAleavey KM. Mindful parenting decreases aggression and increases social behavior in children with developmental disabilities. Behav Modif. 2007 Nov;31(6):749-71. doi: 10.1177/0145445507300924.

    PMID: 17932234BACKGROUND
  • Weiss, J., & Lunsky, Y.. The brief family distress scale: A measure of crisis in caregivers of individuals with autism spectrum disorders. Journal of Child and Family Studies, 20(4): 521-528, 2011.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Intellectual DisabilityDevelopmental DisabilitiesEmpowerment

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Yona Lunsky, PhD CPsych

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Scientist

Study Record Dates

First Submitted

October 24, 2013

First Posted

November 11, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

June 7, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations