Learning Through Play (LTP) Plus Intervention for Depressed Fathers (LTP Plus Dads) (LTP+Dads)

Testing Low-cost Learning Through Play (LTP) Plus Parenting Intervention for Depressed Fathers (LTP Plus Dads) A Cluster Randomized Controlled Trial (RCT)

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: LTP Plus

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.

• Study Type: Interventional
• Enrollment (Actual): 357
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Bin Qasim Town
    • Karachi, Sindh, Pakistan
      • Orangi Town

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LTP Plus; LTP Plus Participants will receive the intervention over 4 months Weekly sessions for 2 months and fortnightly for next two months by trained non-specialists/community health workers.	Behavioral: LTP Plus; LTP+Dads is a 12 - session group integrated parenting intervention: i.e LTP (Learning through Play) which includes a pictorial calendar, consisting of stages of child development from birth to 3 years. It includes parent-child play and other activities that promote parental involvement, learning, and attachment. In each stage, there are five areas of child development: sense of self, physical, relationships, understanding, and communication. All areas are written in simple, low-literacy language. 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. Third component of intervention is content taken from Ed Bader's manual (Focus on Fathers) includes importance of fathers in child development, stress management at work and home, budgeting, anger management, conflict resolution and time management.
NO_INTERVENTION: Treatment As Usual (TAU); Treatment as Usual (TAU) group will receive routine care and their follow up will be done at 4th and 6th month post randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Scale HAM-D 17 (Hamilton, 1960)	The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The HAM-D is a simple 17 item self-report questionnaire can also be administered by a trained research worker. The translated version of the scale has been used in previous studies in Pakistan (Husain et al., 2017). It takes about 10 to 15 minutes to administer this scale. A score of 0-7 indicates normal, 8-13 mild depression, 14-18 moderate depression, 19-22 severe depression and > 22 severe depression	Changes from Baseline to 4th and 6th Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 scale.	Changes from Baseline to 4th and 6th Month
Rosenberg's Self-Esteem Scale (Rosenberg, 1995)	Rosenberg's Self-Esteem Scale will be used to measure self-esteem and personal worthlessness. It is a simple 9 item questionnaire. Higher scores indicate higher self-esteem. The Urdu translated version of scale has been used in our previous studies in Pakistan. (Husain et al 2014; Husain et al., 2017).The scale takes about 5 to 10 minutes to administer	Changes from Baseline to 4th and 6th Month
Brief Disability Questionnaire BDQ:(Von Korff, Ustun, Ormel, Kaplan, & Simon, 1996)	BDQ is a simple 8 Items questionnaire to measure disability in the physical or social life. Total scores across items 1-6 are considered to indicate 'moderate' and 'severe' disability for score ranges 8-13 and 14-22 respectively. The translated version of scale has been used in previous trials in Pakistan (Naeem et al., 2015). It takes about 5 to 10 minutes to administer this scale	Changes from Baseline to 4th and 6th Month
Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003)	The Patient health Questionnaire (PHQ-9) is 10 items self-report questionnaire 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	Changes from Baseline to 4th and 6th Month
Client Satisfaction Questionnaire (CSQ) (Attkisson & Greenfield, 1995)	The participants will rate their satisfaction with the intervention at 4th month using the CSQ, it comprises of 8 items, high scores indicate greater satisfaction (Attkisson & Greenfield, 1995). it takes about 5 minutes to administer this scale	After completion of the intervention at 4th month only
Parenting Scale (Arnold, O'leary, Wolff, & Acker, 1993)	Parent-completed 30-item questionnaire measuring three dysfunctional discipline styles: (1) laxness (permissive discipline), (2) over-reactivity (authoritarian discipline) and (3) verbosity (reliance on talking), with responses rated on a seven-point scale. it takes about 10 minutes to administer this scale.	Changes from Baseline to 4th and 6th Month
Euro-Qol-5 Dimensions (EQ-5D) ( Brooks R. EuroQol,.1996)	Health-related quality of life will be measured by using EQ-5D. This is a standardized instrument that measures five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each scored from 1 to 3 indicating "no problem" to "severe problems". In both the visual analogue scale, and the standardized valuation score, lower scores indicate poorer QOL. It takes about 5 minutes to administer this scale.	Changes from Baseline to 4th and 6th Month
Hurt, Insulted, Threatened with Harm and Screamed (HITS) (Sherin, Sinacore, Li, Zitter, & Shakil, 1998):	HITS is simple 4 item domestic violence screening tool. Each item is scored from 1-5. Range between 4-20. A score greater than 10 signify that an individual are at risk of domestic violence. It takes about 5 minutes to administer this scale. An adapted version of the scale is being used in this study.	Changes from Baseline to 4th and 6th Month
Dyadic Adjustment Scale (DAS):(Spanier, 1976)	DAS is a 32 items self-report questionnaire, to measure couple satisfaction and to assess how each partner perceives his/her relationship. The scale has good psychometric properties (Graham, Liu, & Jeziorski, 2006) and has also been used with depressed mothers (Wolman, Chalmers, Hofmeyr, & Nikodem, 1993). A total DAS score, ranging from 0 to 150, is derived by summing across the four subscales. The 32 items of the DAS are answered on Likert-type scales with questions representing each of the four subscales distributed throughout.It takes about 10 to 15 minutes to administer. The culturally adapted version of the scale is being used in this study.	Changes from Baseline to 4th and 6th Month
Knowledge of Expectation and Child Development	A 25-item questionnaire will be used to assess paternal knowledge and expectations for child development in the first three years. Higher score indicated higher knowledge about child development. (Husain et al 2017) .It takes about 5 to 10 minutes to administer this scale	Changes from Baseline to 4th and 6th Month
OSLO 3 (Nosikov & Gudex, 2003)	Oslo-3 Items social support scale focuses on the quality of social network, perceived positive interest and concern from other people and available help from neighbors if necessary. A score of 3-8 is "poor support", 9-11 is "moderate support" and 12-14 is "strong support". The Urdu version of the scale has already been used in previous studies in Pakistan(Husain, Chaudhry, Jafri, et al., 2014). it takes about 5 minutes to administer this scale.	Changes from Baseline to 4th and 6th Month
Parenting Stress Index - Short Form (Abidin, 1995)	Parents rate 36 items on a five-point rating scale (1-5) on three sub scales: (1) Parenting Distress, (2) Difficult Child Characteristics, and (3) Dysfunctional Parent-Child Interaction. it takes about 10 to 15 minutes to administer this scale.	Changes from Baseline to 4th and 6th Month
Eyberg Child Behaviour Inventory (ECBI) (Eyberg, Boggs, & Reynolds, 1980)	The ECBI is a parent rating scale consisting of items relating specifically to behaviors associated with conduct problems in children. The ECBI is a behaviorally specific instrument consisting of a list of 36 behaviors. It has two scales: (a) The Intensity Scale, which indicates how often these behaviors occur, and (b) The Problem Scale, identifying which specific behaviors are considered as problems by the parents. Rating on intensity scale will be done on seven-point (1-7) whereas on problem scale with YES or NO. it takes about 10-15 minutes to administer this scale.	Changes from Baseline to 4th and 6th Month
Manchester Assessment of Caregiver-Infant Interaction (MACI)	It is designed as a global rating measure, covering general features of parents, infant and dyadic qualities of interaction. It comprises of seven rating scales that covers broad aspects of interaction between a primary caregiver and their infant, each with a seven point scale (Wan, Brooks, Green, Abel, & Elmadih, 2016). It is a method of systematically evaluating qualitative or global aspects of behavioural interaction between a primary caregiver and infant through rating their unstructured play from videotape. Ratings are made along a 7-point scale that show variance across the population Based on 6 minutes of caregiver-infant interaction videotaped in the lab or home.	Changes from Baseline to 6th Month
Anthropometric measures (Weight)	Weight will be measured in Kilograms	Changes from Baseline, to 4th and 6th Month
Anthropometric measures (Height)	Height will be measured in centimeters	Changes from Baseline, to 4th and 6th Month
Anthropometric measures (Head Circumference)	The measurement swill be taken with a device that cannot be stretched, such as a flexible metal tape measure.	Changes from Baseline, to 4th and 6th Month
Anthropometric measures (Arm Circumference)	The measurement swill be taken with a device that cannot be stretched, such as a flexible metal tape measure.	Changes from Baseline, to 4th and 6th Month
Ages and Stages Social-Emotional Questionnaire(Squires et al., 2009)	This scale will be used to measure child development. Parents will report on their child's communication,gross motor, fine motor, problem solving and personal-social development. it takes about 10 minutes to administer this scale.	Changes from Baseline to 4th and 6th Month
Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009)	This scale will be used to measure child development. Parents will report on their child's communication, gross motor, fine motor, problem solving and personal-social at different time points. it takes about 15 to 20 minutes to administer this scale	Changes from Baseline to 4th and 6th Month
Bayley Scales of Infant Development (BSID-V3) (Bayley, Nancy (2006	The Bayley Scales of Infant and Toddler Development is a standard series of measurements originally developed by psychologist Nancy Bayley used primarily to assess the development of infants and toddlers, ages 1-42 months. Scoring: 0 or 1 depending on if the child is able to perform the activity for cognitive, motor(fine and gross subscales), and language(expressive and receptive subscales) scored by examiner. Social-emotional and adaptive questionnaires filled out by parent/caregiver with same scale 0 or 1. The highest possible score on a subtest is 19, and the lowest possible score is 1. Scores from 8 to 12 are considered average.	Changes from Baseline to 6th Month

Collaborators and Investigators

• Sponsor: Pakistan Institute of Living and Learning
• Collaborators: Grand Challenges Canada
• Investigators: Principal Investigator: Nasim Chaudhary, MD, PILL

Publications and helpful links

General Publications

• Husain N, Chaudhry I, Raza-ur-Rehman, Ahmed GR. Self-esteem and obsessive compulsive disorder. J Pak Med Assoc. 2014 Jan;64(1):64-8.
• Hasin DS, Goodwin RD, Stinson FS, Grant BF. Epidemiology of major depressive disorder: results from the National Epidemiologic Survey on Alcoholism and Related Conditions. Arch Gen Psychiatry. 2005 Oct;62(10):1097-106. doi: 10.1001/archpsyc.62.10.1097.
• Hirschfeld RM, Montgomery SA, Keller MB, Kasper S, Schatzberg AF, Moller HJ, Healy D, Baldwin D, Humble M, Versiani M, Montenegro R, Bourgeois M. Social functioning in depression: a review. J Clin Psychiatry. 2000 Apr;61(4):268-75. doi: 10.4088/jcp.v61n0405.
• Husain MI, Chaudhry IB, Husain N, Khoso AB, Rahman RR, Hamirani MM, Hodsoll J, Qurashi I, Deakin JF, Young AH. Minocycline as an adjunct for treatment-resistant depressive symptoms: A pilot randomised placebo-controlled trial. J Psychopharmacol. 2017 Sep;31(9):1166-1175. doi: 10.1177/0269881117724352. Epub 2017 Aug 31.
• Husain N, Chaudhry N, Jafri F, Tomenson B, Surhand I, Mirza I, Chaudhry IB. Prevalence and risk factors for psychological distress and functional disability in urban Pakistan. WHO South East Asia J Public Health. 2014 Apr-Jun;3(2):144-153. doi: 10.4103/2224-3151.206730.
• Husain N, Parveen A, Husain M, Saeed Q, Jafri F, Rahman R, Tomenson B, Chaudhry IB. Prevalence and psychosocial correlates of perinatal depression: a cohort study from urban Pakistan. Arch Womens Ment Health. 2011 Oct;14(5):395-403. doi: 10.1007/s00737-011-0233-3. Epub 2011 Sep 4.
• Kane P, Garber J. The relations among depression in fathers, children's psychopathology, and father-child conflict: a meta-analysis. Clin Psychol Rev. 2004 Jul;24(3):339-60. doi: 10.1016/j.cpr.2004.03.004.
• Kaufman J, Yang BZ, Douglas-Palumberi H, Houshyar S, Lipschitz D, Krystal JH, Gelernter J. Social supports and serotonin transporter gene moderate depression in maltreated children. Proc Natl Acad Sci U S A. 2004 Dec 7;101(49):17316-21. doi: 10.1073/pnas.0404376101. Epub 2004 Nov 24.
• Klein DN, Lewinsohn PM, Rohde P, Seeley JR, Olino TM. Psychopathology in the adolescent and young adult offspring of a community sample of mothers and fathers with major depression. Psychol Med. 2005 Mar;35(3):353-65. doi: 10.1017/s0033291704003587.
• Naeem F, Gul M, Irfan M, Munshi T, Asif A, Rashid S, Khan MN, Ghani S, Malik A, Aslam M, Farooq S, Husain N, Ayub M. Brief culturally adapted CBT (CaCBT) for depression: a randomized controlled trial from Pakistan. J Affect Disord. 2015 May 15;177:101-7. doi: 10.1016/j.jad.2015.02.012. Epub 2015 Feb 23.
• Ramchandani P, Stein A, Evans J, O'Connor TG; ALSPAC study team. Paternal depression in the postnatal period and child development: a prospective population study. Lancet. 2005 Jun 25-Jul 1;365(9478):2201-5. doi: 10.1016/S0140-6736(05)66778-5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): November 30, 2019

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (ACTUAL): June 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Cognitive Behavior Therapy; Low and middle-income country; Parenting Intervention; Learning Through Play Plus
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: PILL-LTP Plus Dads-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No