Clinical trial NCT03564847: Learning Through Play (LTP) Plus Intervention for Depressed Fathers (LTP Plus Dads)
Official title: Testing Low-cost Learning Through Play (LTP) Plus Parenting Intervention for Depressed Fathers (LTP Plus Dads) A Cluster Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Learning Through Play Plus
Cognitive Behavior Therapy
Parenting Intervention
Low and middle-income country
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
First posted: 2018-06-21
Enrollment: 357
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the clinical and cost effectiveness of culturally adapted group parenting intervention delivered by non-specialists and community health workers for depressed fathers.

Detailed description: Most research on the association between parental depression and child outcomes has focused mainly on mothers. However, studies suggest that the relationship between parental depression and child outcome is not necessarily limited to mothers.

The study has two phases quantitative and qualitative:

Purpose of this quantitative phase is to determine if the LTP plus programme delivered by non-specialists and community health workers reduces symptoms of paternal depression and improves child development compared to treatment as usual.

In the qualitative part of the study focus groups and in-depth digitally recorded interviews will be conducted with participants by trained research staff at two-time points both before and after the intervention. These focus groups and in-depth interviews will continue till the data saturation is achieved. In addition, Participants who refused to participate in the trial will be asked if they would be willing to be contacted by a researcher to discuss their reasons for not taking part. Moreover, in-depth digitally-recorded interviews with stakeholders (grandparents, therapists, health professionals, etc) will also be conducted by trained researchers.

Eligibility criteria: Inclusion Criteria:

* 18 to 55 years old fathers
* Having children aged between 0-30 months
* Diagnosis of major depressive disorder using the Structure Clinical Interview for DSM-V,
* Ability to complete a baseline assessment.
* Given written informed consent

Exclusion Criteria:

* Any medical illness that will prevent them from participation in the clinical trial,
* Current or past diagnosis of bipolar depression
* Currently using antidepressants or receiving any kind of psychotherapy
* Active suicidal ideation,
* Any other severe physical or mental disorders

Primary outcomes:
measure: Hamilton Depression Scale HAM-D 17 (Hamilton, 1960)
timeFrame: Changes from Baseline to 4th and 6th Month
Secondary outcomes:
measure: Generalized Anxiety Disorder (GAD) 7 (Spitzer, Kroenke, Williams, & Löwe, 2006):
timeFrame: Changes from Baseline to 4th and 6th Month
measure: Rosenberg's Self-Esteem Scale (Rosenberg, 1995)
timeFrame: Changes from Baseline to 4th and 6th Month
measure: Brief Disability Questionnaire BDQ:(Von Korff, Ustun, Ormel, Kaplan, & Simon, 1996)
timeFrame: Changes from Baseline to 4th and 6th Month
measure: Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003)
timeFrame: Changes from Baseline to 4th and 6th Month
measure: Client Satisfaction Questionnaire (CSQ) (Attkisson & Greenfield, 1995)
timeFrame: After completion of the intervention at 4th month only
measure: Parenting Scale (Arnold, O'leary, Wolff, & Acker, 1993)
timeFrame: Changes from Baseline to 4th and 6th Month
measure: Euro-Qol-5 Dimensions (EQ-5D) ( Brooks R. EuroQol,.1996)
timeFrame: Changes from Baseline to 4th and 6th Month
measure: Hurt, Insulted, Threatened with Harm and Screamed (HITS) (Sherin, Sinacore, Li, Zitter, & Shakil, 1998):
timeFrame: Changes from Baseline to 4th and 6th Month
measure: Dyadic Adjustment Scale (DAS):(Spanier, 1976)
timeFrame: Changes from Baseline to 4th and 6th Month
measure: Knowledge of Expectation and Child Development
timeFrame: Changes from Baseline to 4th and 6th Month
measure: OSLO 3 (Nosikov & Gudex, 2003)
timeFrame: Changes from Baseline to 4th and 6th Month
measure: Parenting Stress Index - Short Form (Abidin, 1995)
timeFrame: Changes from Baseline to 4th and 6th Month
measure: Eyberg Child Behaviour Inventory (ECBI) (Eyberg, Boggs, & Reynolds, 1980)
timeFrame: Changes from Baseline to 4th and 6th Month
measure: Manchester Assessment of Caregiver-Infant Interaction (MACI)
timeFrame: Changes from Baseline to 6th Month
measure: Anthropometric measures (Weight)
timeFrame: Changes from Baseline, to 4th and 6th Month
measure: Anthropometric measures (Height)
timeFrame: Changes from Baseline, to 4th and 6th Month
measure: Anthropometric measures (Head Circumference)
timeFrame: Changes from Baseline, to 4th and 6th Month
measure: Anthropometric measures (Arm Circumference)
timeFrame: Changes from Baseline, to 4th and 6th Month
measure: Ages and Stages Social-Emotional Questionnaire(Squires et al., 2009)
timeFrame: Changes from Baseline to 4th and 6th Month
measure: Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009)
timeFrame: Changes from Baseline to 4th and 6th Month
measure: Bayley Scales of Infant Development (BSID-V3) (Bayley, Nancy (2006
timeFrame: Changes from Baseline to 6th Month
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Bin Qasim Town
state: Sindh
city: Karachi
country: Pakistan
facility: Orangi Town
state: Sindh
Study officials:
affiliation: PILL
name: Nasim Chaudhary, MD
role: PRINCIPAL_INVESTIGATOR
References:
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