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

Depression Clinical Trial

— LTP+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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564847
• Other study ID #: PILL-LTP Plus Dads-002
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: October 2020
• Source: Pakistan Institute of Living and Learning
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Bin Qasim Town	Karachi	Sindh
Pakistan	Orangi Town	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning	Grand Challenges Canada

Country where clinical trial is conducted

Pakistan, 

References & Publications (11)

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. — View Citation

Hirschfeld RM, Montgomery SA, Keller MB, Kasper S, Schatzberg AF, Möller 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2004 Nov 24. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Anthropometric measures (Weight)	Weight will be measured in Kilograms	Changes from Baseline, to 4th and 6th Month
Secondary	Anthropometric measures (Height)	Height will be measured in centimeters	Changes from Baseline, to 4th and 6th Month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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