Trial record 6 of 144 for:    intellectual and developmental disabilities

Parent Supports Intervention Project

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Community Living Toronto (Toronto, Canada)
Surrey Place Centre (Toronto, Canada)
York University
Queen's University
Ontario Ministry of Community and Social Services
Information provided by (Responsible Party):
Yona Lunsky, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01981070
First received: October 24, 2013
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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. 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.

Condition Intervention
Stress
Behavioral: Mindfulness Intervention for Parents
Behavioral: Support and Information for Parents

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Parent Supports Intervention Project for Parents of Adults With Developmental Disabilities

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Depression Stress Anxiety Scale [ Time Frame: 21 weeks following Randomization ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Family Empowerment Scale [ Time Frame: 21 weeks following Randomization ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: October 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mindfulness Intervention for Parents
The mindfulness intervention program incorporates the same structure as the Support and Information for Parents intervention (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 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

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01981070

Locations
Canada, Ontario
CAMH
Toronto, Ontario, Canada, M5V 2B4
Sponsors and Collaborators
Centre for Addiction and Mental Health
Community Living Toronto (Toronto, Canada)
Surrey Place Centre (Toronto, Canada)
York University
Queen's University
Ontario Ministry of Community and Social Services
Investigators
Principal Investigator: Yona Lunsky, PhD CPsych Centre for Addiction and Mental Health
  More Information

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

Responsible Party: Yona Lunsky, Clinician Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01981070     History of Changes
Other Study ID Numbers: 095/2013
Study First Received: October 24, 2013
Last Updated: June 12, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre for Addiction and Mental Health:
parent support
mindfulness
intellectual disability
developmental disability
empowerment
psychological acceptance
parental stress
parental depression

Additional relevant MeSH terms:
Developmental Disabilities
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on August 27, 2014