Parent Supports Intervention Project
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01981070|
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : June 7, 2016
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:
- Support and Information Intervention - provides parents with support and information about services for their sons and daughters
- Mindfulness Intervention - empowers parents through teaching them mindfulness skills
We hypothesize that:
- Parents in both types of interventions will report benefits (reductions in psychological distress) maintained at follow-up.
- 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.
- Parents in mindfulness intervention group will show greater improvements by 3 months follow-up than parents in the support and information group.
|Condition or disease||Intervention/treatment||Phase|
|Stress||Behavioral: Mindfulness Intervention for Parents Behavioral: Support and Information for Parents||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Parent Supports Intervention Project for Parents of Adults With Developmental Disabilities|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Mindfulness Intervention for Parents
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
See Study Arms
Active Comparator: Support and Information for Parents
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
See Study Arms
- Depression Stress Anxiety Scale [ Time Frame: 21 weeks following Randomization ]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.
- Family Empowerment Scale [ Time Frame: 21 weeks following Randomization ]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.
- Five Facet Mindfulness Questionnaire-Short Form [ Time Frame: 21 weeks following Randomization ]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.
- Bangor Mindful Parenting Scale [ Time Frame: 21 weeks following Randomization ]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."
- Self-Compassion Scale-Short Form [ Time Frame: 21 weeks following Randomization ]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."
- Positive Gains Scale [ Time Frame: 21 weeks following Randomization ]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."
- Burden Scale [ Time Frame: 21 weeks following Randomization ]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.
- Brief Family Distress Scale [ Time Frame: 21 weeks following Randomization ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981070
|Toronto, Ontario, Canada, M5V 2B4|
|Principal Investigator:||Yona Lunsky, PhD CPsych||Centre for Addiction and Mental Health|