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StressNCT01981070

Parent Supports Intervention Project

A study testing Mindfulness Intervention for Parents and Support and Information for Parents in people with Stress, run by Centre for Addiction and Mental Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Stress
What is being tested?
Mindfulness Intervention for Parents and Support and Information for Parents
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteCanada
Study dates
Oct 2013to Jul 2015
Phase
Interventional
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • CAMH

    Toronto, Ontario, M5V 2B4

Other trials in Canada

About this study

Official title: Parent Supports Intervention Project for Parents of Adults With Developmental Disabilities

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:

Read more
  1. Support and Information Intervention - provides parents with support and information about services for their sons and daughters
  2. Mindfulness Intervention - empowers parents through teaching them mindfulness skills

We hypothesize that:

  1. Parents in both types of interventions will report benefits (reductions in psychological distress) maintained at follow-up.
  2. 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.
  3. Parents in mindfulness intervention group will show greater improvements by 3 months follow-up than parents in the support and information group.
Read the detailed description

Parents report many positive dimensions of raising a child with IDD, yet at the same time, being a parent to an individual with IDD is associated with increased stress and poorer psychological wellbeing. Through the MAPS (see www.mapsresearch.ca) program, we have been studying the experience of parents of adults with IDD to better understand what contributes to their difficulties, and factors associated with their wellbeing. This research, combined with our recent systematic review on the experience of parents needing services, highlights the need for psychological supports to empower parents and to enhance their ability to care for their children. With the appropriate psychological supports, parents may be able to support their sons/daughters for longer. It is crucial that we invest in researching interventions and promising practices that may enhance the capacity of parents. However, limited research has considered what types of support make a difference in parental well-being.

Parent empowerment, mindfulness and psychological acceptance are key psychological variables related to positive parent outcomes, including the ability to more effectively care for others. Parent empowerment refers to active attempts to change situations through the application of knowledge and skill. Empowerment is possible when parents feel more familiar with services, and more able to advocate and plan for their child. Person directed planning, orientation to services, practical tips and planning are all helpful for empowerment. Psychological acceptance is a process that involves embracing current difficulties without actively attempting to directly change them, thus facilitating positive action in line with an individual's or family's values. Such acceptance can be particularly helpful for parents when stressful events cannot be immediately resolved or addressed.

Mindfulness is related to psychological acceptance, and is defined as the awareness that emerges through paying attention, on purpose, in the present moment, nonjudgementally to the unfolding of experience moment by moment. These latter processes may help parents preserve their emotional energy and reduce those thoughts, attitudes and judgments that can interfere with addressing their needs and the needs of their child. In this way, we expect that increasing psychological acceptance and mindfulness will facilitate parental and family empowerment. Mindfulness is an innovative support that shows particular promise because it may serve to strengthen parent capacity to care in times of stress, may fundamentally alter how parents spend time with their children, and it may help to make parents more effective advocates for their children. There is an emerging evidence base demonstrating the benefits of mindfulness and acceptance based interventions for a host of medical and psychological issues. Recent attention has been paid to teaching mindfulness to caregivers to help them with caregiving. Studies have included caregivers of patients with cancer, adults with dementia, youth with behavioural difficulties, and most recently, children with IDD.

Preliminary research from the UK and the US has demonstrated the benefits that mindfulness based interventions have on parent ability to care for their young children and youth with IDD. Singh and colleagues published case series teaching parents of children with IDD the philosophy and practice of mindfulness. These papers demonstrated that with 12 training sessions, parents reported decreases in child behaviour problems and increased parenting satisfaction. Blackledge and Hayes applied Acceptance and Commitment Therapy to a group of 20 parents of youth with autism and demonstrated significant improvement in general distress, depression, and maternal acceptance immediately following the therapy as well as 3 months later.

Most recently, Dykens and colleagues demonstrated improved mood and reductions in in a cohort of 287 parents of children with IDD participating in Mindfulness Based Stress Reduction in Tennessee, compared to parents participating in a Positive Psychology Support Program. Neece and colleagues reported similar improvements in a group of 100 parents with preschool age children with IDD in California. Most impressive in both studies was the high attendance rate of parents, attributed in part to onsite childcare. A similar group, using a modification of Mindfulness Based Cognitive Therapy (MBCT), developed by team member Zindel Segal and colleagues is currently being evaluated in Wales by team member Richard Hastings and colleagues.

We will evaluate the impact of two community based interventions for parents of adults with IDD who are requesting services. The first intervention is considered current best practice (active control), which will offer parents support and information about services to enhance parent empowerment ("support and information for parents"). This will be compared to an intervention that will target both parent empowerment and psychological acceptance/mindfulness by blending parent support with mindfulness training ("mindfulness intervention for parents"). The idea of adding a psychological intervention to a more practical intervention has been explored in mindfulness research previously and also in the parent training literature more generally. We will compare this intervention to an "active control" so that we can determine the unique contribution of the mindfulness component of the intervention.

Conditions
Stress
Being tested
Mindfulness Intervention for Parents, Support and Information for Parents
Keywords
parent support, mindfulness, intellectual disability, developmental disability, empowerment, psychological acceptance, parental stress, parental depression
Medical subject headings
Intellectual Disability, Developmental Disabilities, Empowerment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Intervention for ParentsBehavioural

    See Study Arms

  • Support and Information for ParentsBehavioural

    See Study Arms

Study groups in NCT01981070
Study groupRoleWhat they receive
Mindfulness Intervention for ParentsOtherThe 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.
Receives: Behavioral: Mindfulness Intervention for Parents
Support and Information for ParentsActive comparatorThis 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).
Receives: Behavioral: Support and Information for Parents

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 21 weeks following Randomization

Secondary outcomes (7)
  1. Family Empowerment Scale

    The Family Empowerment Scale (FES; Koren et al., 1992) is a 34-item measure that assesses feelings of empowerment. The FES is comprised of 3 subscales: Family, Service System and Community/Political and responses are given on a 5-point Likert scale, with 1 being "never" and 5 being "very often." Only two subscales, 12 items each, will be used: Family and Service System.

    Measured: 21 weeks following Randomization

  2. Five Facet Mindfulness Questionnaire-Short Form

    The Five Facet Mindfulness Questionnaire- Short Form (FFMQ-SF; Bohlmeijer, et al, 2011) measures day-to-day mindfulness through 24 items on a 5-point Likert scale, with 1 being "never or very rarely true" and 5 being "very often or always true." It is commonly used in mindfulness research studies.

    Measured: 21 weeks following Randomization

  3. Bangor Mindful Parenting Scale

    The Bangor Mindful Parenting Scale (BMPS; Jones, et al., in press) is a 15-item measure that assesses mindfulness explicitly in the parenting role and was developed for parents of children with developmental disabilities in the UK. Responses are given on a 4-point Likert scale, with 0 being "never true" and 3 being "always true."

    Measured: 21 weeks following Randomization

  4. Self-Compassion Scale-Short Form

    The Self-Compassion Scale-Short Form (SCS-SF, Raes, et al., 2011) is a 12-item questionnaire that measures participant levels of self-compassion. Caregivers will be asked to rate each statement on a 5-point Likert scale, with 1 being "almost never" and 5 being "almost always."

    Measured: 21 weeks following Randomization

  5. Positive Gains Scale

    The Positive Gains Scale (PGS; Pit-ten Cate, 2003) is 7-item measure that assesses caregivers' perceptions of positive contributions their child has made to their lives. The measure utilizes a 5-point Likert scale, ranging from 1 being "strongly agree" to 5 being "strongly disagree."

    Measured: 21 weeks following Randomization

  6. Burden Scale

    The Caregiver Burden scale measures subjective feelings of caregiver burden using the 9-item burden subscale of the Revised Caregiver Appraisal Scale (Lawton, Kleban, Moss, Rovine \& Glicksman, 2000). Items measure caregiver's perception of the negative impacts caregiving has had on his or her health, well-being, social life and personal relationships. The items utilize a 5-point Likert scale ranging from 5 being "agree a lot" to 1 being "disagree a lot." Total scores range from 9 to 45, with higher scores indicating higher levels of perceived burden.

    Measured: 21 weeks following Randomization

  7. Brief Family Distress Scale

    The Brief Family Distress Scale (BFDS; Weiss \& Lunsky, 2011) measures family distress. Parents will be asked to select one of ten statements that best represents where their families are in terms of crisis. Each of the 10 statements corresponds to a number, with 0 being "no stress" and 10 being "crisis." This measure will only be given at baseline to match families on distress.

    Measured: 21 weeks following Randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01981070
Sponsor's protocol ID
095/2013
Status last verified
Jun 2016
First submitted
24 Oct 2013
Last updated
7 Jun 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16443717
  • 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.

  • 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.

    PubMed 21586480
  • 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.

    PubMed 11305069
  • 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.

    PubMed 19412664
  • 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.

  • 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.

  • 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.

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

  • 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.

    PubMed 16300724
  • 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.

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

  • 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.

  • 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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Intervention for Parents and Support and Information for Parents in people with Stress, run by Centre for Addiction and Mental Health at 1 site in Canada.

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 7 Jun 2016. 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Depression Stress Anxiety Scale (time frame: 21 weeks following Randomization). 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 NCT01981070, which also lists 22 linked publications.

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 7 Jun 2016.

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