Intellectual DisabilityUmeedNCT03683706
Learning Through Play (LTP) in My Own Way Plus CBT
A study testing LTP in My Own Way Plus in people with Intellectual Disability and Depression, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial summary
Aim of the study is to evaluate the acceptability and feasibility of LTP in My Own Way Plus with depressed mothers of ID children. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability, Depression
- What is being tested?
- LTP in My Own Way Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2019to 8 Oct 2020
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mothers of ID children aged 3 to 6 years, screened positive for depression
- Ability to complete a baseline assessment
- Ability to communicate in Urdu or English
Who cannot join
- Have a diagnosed serious medical or psychiatric condition
- Mothers of children with other medical illness
- Temporary residents unlikely to be available for follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Trial of Learning Through Play (LTP) in My Own Way Plus CBT A Parent-Based Intervention for Depressed Mothers With ID Children
Aim of the study is to evaluate the acceptability and feasibility of LTP in My Own Way Plus with depressed mothers of ID children.
Read the detailed description
Having a child with a chronic medical problem or an intellectual disability increases anxiety and depression in parents. There is some growing evidence that families of ID children are able to meet the challenges. The purpose of the present study is to adapt LTP in my own way plus to test its acceptability and determine if it improves mothers knowledge about their child development and reduce their level of distress.
The study has two phases: quantitative phase and qualitative phase. Quantitative phase: A single blind randomised controlled trial in school settings in Karachi Pakistan.
Objectives:
- Help mothers cope better with their depression.
- Teach mothers play activities that will stimulate their children's development and improve mother-child interaction.
Qualitative Phase: This will help to determine acceptability of the intervention and identify perceived mechanisms of change and any barriers and facilitators to LTP in my own Plus intervention. In-depth digitally recorded interviews and focus groups will be conducted with the parents and teachers to understand their beliefs, views, and feelings about caring for ID children.
- Conditions
- Intellectual Disability, Depression
- Being tested
- LTP in My Own Way Plus
- Medical subject headings
- Intellectual Disability, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTP in My Own Way PlusBehavioural
LTP in My Own Way Plus is a 12-session integrated intervention-Learning through Play in My Own Way Plus Cognitive Behaviour Therapy (CBT). LTP in My Own Way is the extension of the parent education program called 'Learning Through Play' developed by Toronto Public Health (1993) revised by The Hincks-Dellcrest Centre (2000). LTP aims for the healthy growth of young children (birth to 6 years) using the stages of development incorporating Piaget's theory of cognitive development and Bowlby's theory of attachment. The objective of this program is to strengthen parent-child attachment by encouraging parental involvement and teaching parents how to use play activities to enhance their children's development. Second component of intervention is CBT adapted from Jeanne Miranda manual (Group CBT for Depression, group leaders guide book-2006) focusing on the three areas: thoughts and your mood, activities and your mood, people interaction and your mood.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Participants in this arm will receive 12 sessions of LTP in My Own Way Plus interventions. Receives: Behavioral: LTP in My Own Way Plus |
| Treatment as Usual | No intervention | Participants in this arm will be getting their usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Session Log (Feasibility and acceptability)
sessions logs (attendance of each participant) will be maintained.
Measured: change in baseline to 12 weeks
Secondary outcomes (3)
Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003):
The Patient health Questionnaire (PHQ-9) is 10 items self-report questionnaire for screening, diagnosing and measuring severity of depression which is easy to use and can be administered by a trained research worker. Score ranges from 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Measured: change in baseline to 12 weeks
Generalized Anxiety Disorder (GAD) 7 (Spitzer, Kroenke, Williams, & Löwe, 2006):
The GAD-7 is a 7-item scale used to screen for and measure severity of generalized anxiety disorder. Scores of 5, 10 \& 15 are taken as cut-off points for mild, moderate and high. it takes about 5 minutes to administer this sca
Measured: change in baseline to 12 weeks
Vineland Adpative Behaviour Scales (VABS-II) VABS-II (Sparrow et al., 2005):
VABS-II measure adaptive behaviors of individuals from birth to 90 years. The main domains are communication, daily living skills, socialization, and motor skills. The parent/caregiver self-report form requires a completion time of 30-60 minutes and yields an adaptive behaviour composite score.
Measured: change in baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start15 Mar 2019
- Primary completion8 Oct 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasim Chaudhry, Principal investigator, Pakistan Institute of Living & Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683706
- Sponsor's protocol ID
- LTP In My Own Way Plus
- Acronym
- Umeed
- Status last verified
- Oct 2020
- First submitted
- 19 Sep 2018
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of Learning Through Play (LTP) in My Own Way Plus CBT A Parent-Based Intervention for Depressed Mothers With ID Children
- ClinicalTrials.gov ID
- NCT03683706
- Acronym / sponsor ID
- Umeed / LTP In My Own Way Plus
- Conditions
- Intellectual Disability, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is to evaluate the acceptability and feasibility of LTP in My Own Way Plus with depressed mothers of ID children.
Detailed description
Having a child with a chronic medical problem or an intellectual disability increases anxiety and depression in parents. There is some growing evidence that families of ID children are able to meet the challenges. The purpose of the present study is to adapt LTP in my own way plus to test its acceptability and determine if it improves mothers knowledge about their child development and reduce their level of distress.
The study has two phases: quantitative phase and qualitative phase. Quantitative phase: A single blind randomised controlled trial in school settings in Karachi Pakistan.
Objectives:
- Help mothers cope better with their depression.
- Teach mothers play activities that will stimulate their children's development and improve mother-child interaction.
Qualitative Phase: This will help to determine acceptability of the intervention and identify perceived mechanisms of change and any barriers and facilitators to LTP in my own Plus intervention. In-depth digitally recorded interviews and focus groups will be conducted with the parents and teachers to understand their beliefs, views, and feelings about caring for ID children.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: LTP in My Own Way PlusParticipants in this arm will receive 12 sessions of LTP in My Own Way Plus interventions. |
| Treatment as Usual | No intervention | –Participants in this arm will be getting their usual treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mothers of ID children aged 3 to 6 years, screened positive for depression
- Ability to complete a baseline assessment
- Ability to communicate in Urdu or English
Key exclusion criteria (3 listed)
- Have a diagnosed serious medical or psychiatric condition
- Mothers of children with other medical illness
- Temporary residents unlikely to be available for follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTP in My Own Way PlusLTP in My Own Way Plus is a 12-session integrated intervention-Learning through Play in My Own Way Plus Cognitive Behaviour Therapy (CBT). LTP in My Own Way is the extension of the parent education program called 'Learning Through Play' developed by Toronto Public Health (1993) revised by The Hincks-Dellcrest Centre (2000). LTP aims for the healthy growth of young children (birth to 6 years) using the stages of development incorporating Piaget's theory of cognitive development and Bowlby's theory of attachment. The objective of this program is to strengthen parent-child attachment by encouraging parental involvement and teaching parents how to use play activities to enhance their children's development. Second component of intervention is CBT adapted from Jeanne Miranda manual (Group CBT for Depression, group leaders guide book-2006) focusing on the three areas: thoughts and your mood, activities and your mood, people interaction and your mood. | Behavioural | Intervention |
Primary outcome
Session Log (Feasibility and acceptability)
Time frame: change in baseline to 12 weeks
sessions logs (attendance of each participant) will be maintained.
3 secondary outcomes
Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003):
Time frame: change in baseline to 12 weeks
Generalized Anxiety Disorder (GAD) 7 (Spitzer, Kroenke, Williams, & Löwe, 2006):
Time frame: change in baseline to 12 weeks
Vineland Adpative Behaviour Scales (VABS-II) VABS-II (Sparrow et al., 2005):
Time frame: change in baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasim Chaudhry principal investigator
Pakistan Institute of Living & Learning
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LTP in My Own Way Plus in people with Intellectual Disability and Depression, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
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 3 inclusion and 3 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 14 Oct 2020. 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 Pakistan. 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?
Session Log (Feasibility and acceptability) (time frame: change in baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2020.