Learning Through Play (LTP) in My Own Way Plus CBT

NCT03683706 | Completed DMC

• 1 other identifier: LTP In My Own Way Plus
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intellectual Disability; Depression

Outcome Measures

Primary Outcomes (1)

• Session Log (Feasibility and acceptability)

  sessions logs (attendance of each participant) will be maintained.

  change in baseline to 12 weeks

Secondary Outcomes (3)

• Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003):

  change in baseline to 12 weeks

• Generalized Anxiety Disorder (GAD) 7 (Spitzer, Kroenke, Williams, & Löwe, 2006):

  change in baseline to 12 weeks

• Vineland Adpative Behaviour Scales (VABS-II) VABS-II (Sparrow et al., 2005):

  change in baseline to 12 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Participants in this arm will receive 12 sessions of LTP in My Own Way Plus interventions.

Behavioral: LTP in My Own Way Plus

Treatment as Usual

NO INTERVENTION

Participants in this arm will be getting their usual treatment

Interventions

LTP in My Own Way Plus BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Have a diagnosed serious medical or psychiatric condition
• Mothers of children with other medical illness
• Temporary residents unlikely to be available for follow-up

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (1)

A private school in Karachi

Karachi, 75500, Pakistan

Location

MeSH Terms

Conditions

Intellectual Disability; Depression

Interventions

Long-Term Potentiation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nasim Chaudhry

  Pakistan Institute of Living & Learning

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers doing outcome assessments will be kept blind to treatment allocations
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 25, 2018
• Study Start: March 15, 2019
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)